Rapid Micro Methods News

PRESS RELEASE: Rapid Molecular Test for Flu and COVID-19 on FINDER Platform Gets FDA Clearance and CLIA-Waiver

2026-04-06T08:29:00.001-04:00

Image created by Dr. Michael J. Miller

The Food and Drug Administration (FDA) has granted 510(k) clearance for Baebies‘ FINDER Flu A&B/SARS-CoV-2 Test, which also received CLIA-waiver approval. The rapid RT-PCR assay runs on the FINDER platform, establishing it as a molecular point-of-care platform with multifunctional capabilities, according to Baebies.

The automated system is designed for use in decentralized settings, including urgent care centers, emergency departments, and clinics. It delivers positive results in as early as 15 minutes and negative results in approximately 20 minutes.

“For too long, testing in decentralized settings has been fragmented across multiple instruments,” says Richard West, founder and CEO of Baebies, in a release. “This clearance expands our opportunity in urgent care, the ED, and other near-patient settings, and builds an installed base that can be leveraged to support multifunctional assays on the same platform.”

Technology and Workflow

The FINDER platform is powered by digital microfluidics, combining rapid PCR with integrated sample preparation in a fully enclosed cartridge. The workflow is designed to meet the demands of urgent care settings, which require speed and minimal hands-on time to support diagnostic decisions during a patient visit.

Beyond the respiratory test, the company is developing a broader molecular menu. This pipeline includes high-plex panels for pathogens detected from blood, urine, nasal, and vaginal swabs, host-response transcriptomic assays, and quantitative PCR programs for HIV and HCV.

Multifunctional Platform Capabilities

The platform’s capabilities extend beyond molecular diagnostics. The system previously received FDA 510(k) clearance for a G6PD test, and its Anti-Factor Xa Test received FDA Breakthrough Device Designation as a point-of-care heparin monitoring assay.

“FINDER is designed to deliver the speed and menu breadth needed for single-visit diagnostic decisions, helping clinicians get patients the right care without sending them to multiple instruments or settings,” says Vamsee Pamula, PhD, founder and president of Baebies, in a release.

The company says the platform aims to make diagnostic testing more accessible in near-patient settings. The FINDER system was previously recognized with the Association for Diagnostics & Laboratory Medicine Disruptive Technology Award.

PRESS RELEASE: HudsonAlpha Affiliate GeneCapture Unveils Rapid Infection Testing Breakthrough

2026-04-06T08:22:00.002-04:00

Image created by Dr. Michael J. Miller

The HudsonAlpha Institute for Biotechnology associate company demonstrated its breakthrough diagnostic technology to local clinicians and physicians. Their portable, lab-free platform enables identification of the correct antibiotic treatment in near real-time. While traditional hospital diagnostics can often take two to four days to process raw samples, GeneCapture’s technology uses a combination of sequence-based probes, biochemical reactions and optical cytometry to move from patient sample to prescription in 2 hours.

“We’ve just completed an important milestone – a diagnostic study to determine which drugs would best treat a specific infection,” said Paula Millirons, GeneCapture Chief Scientist. “We manually validated the process and the results show an impressive 98% match to the gold standard results a hospital would obtain; however, we did it in 2 hours instead of the typical 2 to 3 days.”

“The speed to treatment will improve health outcomes, especially as antimicrobial resistance is on the rise,” said Louise O’Keefe, PhD, CRNP, and Professor Emerita at UAH, upon reviewing the data with GeneCapture scientists.

GeneCapture CEO Peggy Sammon said the implications of the study are far-reaching. “Imagine getting the right drug, right away, without a laboratory. This will reduce costs, contagion, and sepsis,” Sammon said. “Our goal is to provide inexpensive portable equipment to clinics, schools, nursing homes, cruise ships, rural health centers, and any location without laboratory access. The era of waiting days for results will soon be over.”

Recent testing confirmed the rapid workflow, which was designed by a team of microbiologists and biomedical engineers at GeneCapture’s lab at HudsonAlpha. The innovations will allow a small disposable cartridge and a compact instrument to read the results. The technology can detect multiple pathogens. This specific study focused on urinary tract infections, a commonly misdiagnosed condition that can rapidly escalate into serious complications if not treated promptly and correctly.

GeneCapture’s sample to prescription approach is defined by three core innovations: a rapid pathogen identification system that uses a molecular signature-matching algorithm; a miniaturized biochemical growth chamber for accelerated bacterial growth; and a proprietary method for sorting, distinguishing, and counting the bacteria before and after exposure to antibiotics. The platform will accept urine, swab, and blood.

“We have come to expect significant breakthroughs from our associate companies, and GeneCapture’s latest achievement is a true ‘leap ahead’ for diagnostic care,” said Neil Lamb, PhD, president of HudsonAlpha. “This demonstration proves that the future for rapid, accessible infectious disease management is being built right here in Huntsville. We congratulate the entire team on this milestone.”

GeneCapture has successfully completed the FDA pre-submission process and is now preparing the cartridge and instrument for clinical tests. In addition to its commercial progress, the company has secured multiple government contracts to develop rapid infection diagnostic techniques for battlefield use, including a current contract focused on identifying the source of emerging unknown biothreats.

The platform will enable the company’s Global Infection Grid™, which will be a network for predicting global infection pathways and identifying mutations. Think of it as a weather map for infections: showing where dangerous strains are appearing, which antibiotics are losing their effectiveness, and where the next outbreak might hit.

PRESS RELEASE: bioMérieux Invests in Plair to Advance Environmental Monitoring in Pharma

2026-03-31T08:50:00.001-04:00

Image created by Dr. Michael J. Miller

bioMérieux, a world leader in in vitro diagnostics headquartered in Marcy-l’Étoile, France, has announced an investment of over CHF 1 million in Plair, a Geneva-based scale-up developing real-time microbial detection and air sampling solutions. The investment marks a strategic expansion of bioMérieux’s pharmaceutical quality control offering and establishes a formal partnership between the two companies. As part of the collaboration, Michael Reynier, Senior Vice President of Pharma Quality Control at bioMérieux, will join Plair’s Board of Directors.

Founded as a spin-off of the University of Geneva, Plair specializes in professional environmental monitoring systems using proprietary laser-based detection technology capable of identifying allergens, air pollution, bacteria, and virus aerosols in real time. Its flagship product, RAPID-C+, is a unique real-time viable particle counter that combines total and viable particle counting with continuous certified sampling on standard agar media, enabling microbial identification and supporting faster, more informed decision-making in pharmaceutical cleanroom environments. The product is already commercially available.

The partnership addresses a growing need in pharmaceutical manufacturing, where environmental monitoring in cleanrooms is subject to increasingly stringent regulatory requirements. RAPID-C+’s biofluorescent particle counting methodology represents a new approach to this challenge, and bioMérieux’s endorsement is expected to accelerate its regulatory acceptance and industry adoption.

The investment builds on Plair’s earlier institutional backing, including a CHF 300,000 growth loan awarded by the FONGIT Innovation Fund in 2023, and reinforces Geneva’s position as a hub for precision environmental sensing and life sciences innovation. With bioMérieux present in more than 160 countries, the partnership provides Plair with a global commercial platform to scale its technology across the pharmaceutical industry.

PRESS RELEASE: BabyCue Receives Government Support to Develop Rapid Diagnostic for Childhood Diarrhoea

2026-03-30T14:10:00.001-04:00

Image created by Dr. Michael J. Miller

The Technology Development Board of the Department of Science and Technology, Government of India, has provided financial assistance to Cuttack-based startup BabyCue for a project to develop a disposable paper analytical device for rapid detection of childhood diarrhoea.

The project focuses on commercialising indigenous rapid diagnostic kits, which have been designed to detect the difference between bacterial and non-bacterial diarrhoea in children in a timely manner.

The proposed product, DyCue Diagnostic Kit is an important indigenous innovation combining biotechnology and materials science to tackle the widespread problem of diarrhoea in the country. The kit is designed as a quick, non-harmless and cost-effective diagnostic tool that can also be used in rural health centres and temporary diagnostic centres.

The device is based on lateral flow assay (LFA) technology, which rapidly identifies disease using disease-specific fecal biomarkers. The system uses gold nanoparticle-based colorimetric detection, allowing results to be visually understood without the need for specialised laboratory equipment. The use of proprietary biomarkers and specially designed reagents ensures high sensitivity and specificity, making it possible to make a reliable distinction between bacterial and non-bacterial infections. Proprietary biomarkers are patented, biological indicators (molecules, genes, or imaging characteristics) that are made by specialty pharmaceutical, diagnostic, or biotech companies to detect diseases, predict treatment efficacy, or drug efficacy.

The technology has been developed in collaboration with National Institute of Pharmaceutical Education and Research, Hyderabad and has been clinically validated at ESIC Hospital, Hyderabad.

Technology Development Board will help the company to accelerate product development, increase manufacturing capacity and deploy this diagnostic solution widely for the benefit of healthcare providers and patients.

PRESS RELEASE: NomadX Wins Award for Biotech R&D Excellence in Food Safety

2026-03-30T12:36:00.001-04:00

Image created by Dr. Michael J. Miller

NomadX, a leader in next generation pathogen detection, has been recognized in the Global 100 – 2026 Awards for its outstanding contributions to Biotech R&D. The company’s integrated approach to pathogen detection, decontamination, and data driven analytics is transforming how the food industry prevents contamination and safeguards public health.

NomadX’s work is redefining what modern food safety can achieve through comprehensive decontamination processes, advanced microbiology, sensing technologies, and rapid, same shift detection capabilities. By combining proactive decontamination, superior sample collection and concentration, and real time analytics, the company is enabling food producers to identify and eliminate threats earlier and more effectively across the entire supply chain.

“Our mission has always been clear: to eliminate contaminated food products from reaching consumers by making food testing faster, more reliable, and verifiable at scale,” said a NomadX CEO, Lyle Probst. “This recognition affirms the impact of combining rigorous science with practical innovation to address challenges that matter to producers, regulators, and consumers worldwide.”

With nonhazardous decontamination technologies capable of targeting contamination from farm through packaging, and spectroscopy based same-shift detection capabilities designed to detect whole, viable bacteria without lengthy enrichment, NomadX is helping facilities move from reactive testing toward proactive prevention.

The company continues to expand its R&D pipeline, advance its real time detection platforms, and support food producers, processors, and industry decision makers committed to achieving the highest safety standards.

About NomadX

NomadX is a biotechnology company developing full solution food safety systems that integrate comprehensive decontamination, enhanced sample collection and concentration, and rapid pathogen detection. NomadX’s technologies are engineered to eliminate pathogens at their source, deliver same day actionable results, and help producers meet stringent regulatory requirements. The organization’s mission is to make global food systems safer, more efficient, and more transparent to help ensure the safety of consumers.

PRESS RELEASE: Cepheid Selected by CDC as National Collaborator, Advancing Rapid Diagnostic Innovation to Strengthen U.S. Pandemic Preparedness

2026-03-30T12:26:00.001-04:00

Image created by Dr. Michael J. Miller

Cepheid today announced that it has been selected by the U.S. Centers for Disease Control and Prevention (CDC) as one of four national collaborators under a new federal initiative designed to accelerate the development and deployment of rapid diagnostic technologies during public health emergencies. The award—issued under a multiple-award Indefinite Delivery-Indefinite Quantity (IDIQ)1 contract—reinforces Cepheid’s longstanding leadership in outbreak response and its commitment to bolstering the nation's pandemic readiness.

Through this collaboration, CDC can provide Cepheid with early access to outbreak samples, genomic sequences, and critical reference materials. This access aims to help close development gaps during early pathogen emergence and accelerate the creation of next-generation diagnostic assays, ensuring that rapid, accurate testing can be deployed quickly when new threats arise.

"For years, Cepheid has been at the forefront of outbreak response," said Vitor Rocha, President of Cepheid. "We are honored to be selected by CDC for this IDIQ award for rapid, scalable diagnostics, and we are confident the collaboration can leverage our pioneering technology and global footprint to help public health systems respond swiftly and effectively to emerging challenges."

Accelerating Diagnostic Readiness for Future Threats

Cepheid's integrated PCR systems are designed to deliver fast, accurate results wherever testing is needed—from major health systems to remote settings. By supporting real-time surveillance, early detection, and evidence-based decision-making, Cepheid's innovations help fortify public health infrastructure and expand rapid response capabilities globally.

"Cepheid has proven we can reliably deliver quality molecular diagnostics when they're needed most," said Larry Kelmar, Vice President, Government Programs and Pharma Collaborations at Cepheid. "Working closely with partners like the CDC strengthens our ability to rapidly respond to new outbreaks and safeguard communities with advanced, high-impact testing solutions."

Cepheid's legacy of rapid assay development was exemplified during the COVID-19 pandemic, when the company launched the first point-of-care PCR test for SARS-CoV-2 in the United States2 within weeks of the viral sequence being published. This milestone demonstrated the company's ability to compress development timelines without compromising accuracy or quality—capabilities that remain central to its role in national emergency preparedness.

Supporting a Stronger Public Health Future

As part of this multi-award IDIQ framework, Cepheid will contribute to a coordinated national effort to modernize outbreak detection, accelerate diagnostic innovation, and ensure testing remains agile in the face of evolving threats. This collaboration underscores the importance of public-private partnerships for rapid scaling, scientific advancement, and operational readiness.

"We remain committed to developing transformative diagnostics that empower healthcare providers and protect public health nationwide," added Kelmar. "CDC's selection reflects not only our technical expertise but also the critical need for sustained collaboration to ensure the country is ready for whatever comes next."

PRESS RELEASE: FDA Grants Breakthrough Device Designation to Two Rapid Tests Targeting Critical Drug-Resistant Pathogens

2026-03-30T12:22:00.001-04:00

Image created by Dr. Michael J. Miller

In a major step forward against Antimicrobial Resistance (AMR), NG Biotech, in partnership with Hardy Diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designations to two rapid diagnostic assays: NG-TEST® Candida auris and NG-TEST® Acineto-5®. The designation recognizes technologies with the potential to address life-threatening conditions and significant unmet medical needs.

Both tests target pathogens classified as critical priorities by the World Health Organization (WHO). Candida auris, listed in the WHO Fungal Priority Pathogens List (2022), is a multidrug-resistant yeast responsible for hospital outbreaks worldwide. It is often difficult to detect and associated with high mortality. Carbapenem-resistant Acinetobacter baumannii (CRAB), included in the WHO Bacterial Priority Pathogens List (2024), is among the most dangerous hospital-acquired bacteria due to its resistance profile and rapid transmission in healthcare settings.

NG-TEST® Candida auris is the first rapid lateral flow immunoassay specifically designed to identify C. auris from cultured samples in 15 minutes. Published data demonstrate 100% concordance with reference methods across diverse isolates, supporting its role in outbreak investigation and infection control.

NG-TEST® Acineto-5® detects and differentiates five major carbapenemase families--OXA-23-like, OXA-24/143-like, OXA-58-like, VIM, and NDM--directly from Acinetobacter samples, also delivering results within 15 minutes. The PCR-free assay is designed for ease of use, without specialized equipment.

"These breakthrough designations validate both the technology behind our assays and the real-world need they address," said Milovan Stankov-Pugès, CEO, NG Biotech.

"The designation underscores the growing urgency around rapid detection of multidrug-resistant organisms that pose serious risks in healthcare settings," said Andre Hsiung, Chief Scientific Officer of Hardy Diagnostics.

Developed and manufactured in France by NG Biotech, the assays are distributed exclusively in the United States by Hardy Diagnostics. They are currently available for Research Use Only while FDA review continues.

By accelerating detection of high-risk pathogens, these breakthrough-designated tests aim to strengthen surveillance, guide infection control decisions, and support global efforts to fight antimicrobial resistance.

PRESS RELEASE: Visby Medical Collaborates with Watchmaker Genomics to Enhance Respiratory Pathogen Detection in the At-Home Setting

2026-02-08T15:04:00.001-05:00

Image created by Dr. Michael J. Miller

Visby Medical, a leading innovator in at-home PCR testing of infectious diseases, has announced a strategic collaboration with Watchmaker Genomics, a supplier of innovative products for molecular analysis, to develop next-generation diagnostic tests for respiratory pathogen detection in the at-home setting. This partnership pairs Visby Medical’s instrument-free PCR testing technology – the first and only of its kind – with Watchmaker’s expertise in engineering enzymes to address application-specific performance gaps.

Clinical samples collected from patients for at-home testing are typically unprocessed, making them vulnerable to molecular inhibitors that can reduce signal strength and lower assay sensitivity. The need for rapid results in the at-home setting also places unique performance demands on the assays and the enzymes they rely on.

“Recent increases in COVID cases involving new strains and the current flu season highlight the need for tests that are reliable and fast,” explained Gary Schoolnik, MD, infectious disease expert, Chief Medical Officer at Visby Medical, and Professor of Medicine at Stanford University. “Every patient and their healthcare professional needs test results they can have confidence in so that appropriate treatment decisions can be made quickly for optimal recovery, infection control, and the judicious use of antibiotics. The essential tool is rapid PCR testing that does not require instruments or extended lab preparation.”

“This partnership underscores Watchmaker’s commitment to delivering solutions that address real issues in clinically relevant applications, and we are excited to work with Visby Medical to provide a unique and urgently needed solution that utilizes their PCR platform,” stated Trey Foskett, Co-Founder, and CEO of Watchmaker Genomics. “Our StellarScript HT+ Reverse Transcriptase is engineered to be highly inhibitor-tolerant and thermostable – the novel enzyme is an excellent fit for rapid pathogen detection.”

Watchmaker Genomics applies advanced enzymology to enable breakthrough applications for the reading, writing, and editing of DNA and RNA. The company combines domain expertise in protein engineering with large-scale enzyme manufacturing to address the demanding quality, performance, and scale requirements of high-growth clinical genomics applications. Watchmaker’s product portfolio includes enzymes and kits for next-generation sequencing, synthetic biology, and molecular diagnostics.

Founded in 2012, Visby Medical is revolutionizing infectious disease diagnosis by empowering users to accurately test for infections anywhere, anytime, with laboratory accuracy. The company’s proprietary technology platform delivers true PCR results in under 30 minutes through the world’s first instrument-free, single-use PCR tests that fit in the palm of your hand. Currently, Visby Medical offers FDA-cleared tests for sexually transmitted infections (STIs) directly to consumers in the comfort of their own home. Visby Medical is actively expanding its platform targeting other critical respiratory and sexual health pathogens.

PRESS RELEASE: MedGenome Launches MetaSeq to Detect Over 1,400 Pathogens in a Single Blood Test

2026-02-08T14:58:00.001-05:00

Image created by Dr. Michael J. Miller

MedGenome has announced the launch of MetaSeq, an advanced blood test designed to enable faster and more comprehensive detection of bloodstream infections (BSIs). The test delivers results in approximately five days and has demonstrated higher sensitivity than standard blood culture methods, supporting clinicians in making earlier and more informed treatment decisions—particularly for critically ill and immunocompromised patients, where timely intervention is critical.

MetaSeq leverages metagenomic next-generation sequencing (NGS) to analyse microbial cell-free DNA (cfDNA) present in the bloodstream. This approach enables the identification of over 1,400 clinically relevant pathogens—including bacteria, fungi, parasites, and DNA viruses—through a single test, eliminating the need for multiple targeted assays.

Conventionally, bloodstream infections are diagnosed using blood culture tests, which can take several days and often yield false-negative results, especially in patients who have already received antibiotics. MetaSeq overcomes these limitations by detecting microbial DNA directly from blood samples, enabling accurate pathogen identification even when traditional methods are inconclusive.

MetaSeq is CE-IVD validated for peripheral blood samples and can also be performed on other clinical sample types, including cerebrospinal fluid, synovial fluid, and ascitic fluid.

Commenting on the launch, Vedam Ramprasad, PhD, CEO, MedGenome Labs Ltd, said, “Diagnosing bloodstream infections remains one of the most challenging aspects of clinical care. Physicians are often forced to rely on symptom-based provisional diagnoses and probability-driven treatment decisions, leading to prolonged therapies, repeated testing, and delays in administering the right treatment.”

He added that the advanced blood test enables early and accurate diagnosis through genomics-driven, actionable insights.

“MetaSeq transforms clinical decision-making by providing precise diagnostic visibility earlier in the care pathway, empowering clinicians with timely and reliable information and ultimately improving patient outcomes. With MetaSeq, we are raising the benchmark for speed, sensitivity, and reliability in infectious disease diagnostics in India," he said.

MedGenome developed MetaSeq in partnership with Noscendo, a Germany-based company specialising in software-driven pathogen diagnostics. The test is powered by Noscendo’s DISQVER® platform, which employs advanced bioinformatics algorithms for accurate pathogen identification. DISQVER® is recognised by the World Health Organisation (WHO) as the only clinically approved NGS platform for diagnosing invasive fungal diseases.

Andreas Käpplein, CEO, Noscendo, said, “This collaboration between MedGenome and Noscendo has the potential to revolutionise infection diagnostics in South Asia. With precise pathogen identification, MetaSeq lays the foundation for faster and more accurate diagnosis of infections. In critical cases, this can significantly improve treatment outcomes and even save lives. Patients across India can now benefit from these advancements.”

PRESS RELEASE: Berlin Water Utility Lab Delivers Legionella Test Results Within 24 Hours

2026-02-08T14:46:00.003-05:00

Image created by Dr. Michael J. Miller

The laboratory of the Berlin Water Utility has been commissioned to enhance the safety of public drinking water by providing rapid testing for Legionella bacteria in 450 state-owned properties, which include schools, administrative offices, police stations, and fire departments. This initiative aims to ensure the ongoing safety and quality of Berlin's public water supply, especially in buildings with high occupancy and critical public service functions.

State property managers are required to regularly assess water quality to comply with legal standards and to protect public health. This includes mandatory annual testing of warm water systems for Legionella, a bacterium that can cause serious respiratory illness. The Berlin Water Utility's laboratory will now handle these tests, enabling a more centralized and efficient approach to water safety monitoring across Berlin's government facilities.

One of the major advancements introduced by the laboratory is the use of molecular biological PCR analysis. This method significantly reduces the waiting period for Legionella test results from the conventional eleven days to just one day. Faster results allow property managers to respond promptly in the event of contamination, minimizing health risks to building occupants and ensuring more effective management of water systems.

The data exchange and reporting process has also been streamlined. Test results and relevant data will be shared through the public digital platform "Hygiene Monitor," operated by the Berlin Water Utility. This digital solution exemplifies how technology is being leveraged to enhance collaboration among state agencies and to improve the speed and transparency of water quality management. The platform allows for secure, rapid communication of test outcomes, enabling stakeholders to act swiftly if water quality concerns are detected.

Each year, the Berlin Water Utility laboratory analyzes more than 60,000 water samples for a range of contaminants, including chemical, virological, and bacterial agents. The inclusion of comprehensive Legionella testing in state-owned buildings extends the laboratory's role in safeguarding the quality of Berlin's public water supply. Through its advanced technology and improved reporting procedures, the laboratory is positioned to set a new standard in public health protection.

Legionella bacteria pose a particular risk in large or older buildings where water can stagnate in pipes, allowing the bacteria to multiply. By ensuring that testing is both more frequent and more rapid, Berlin's public sector is taking proactive steps to mitigate the risk of Legionella outbreaks. The new system not only supports compliance with health regulations but also demonstrates a commitment to the well-being of the city's residents and public sector workers.

This initiative comes at a time when concerns about waterborne diseases are increasing, and the rapid identification of contamination sources is crucial for preventing outbreaks. The integration of digital tools and advanced laboratory methods reflects a broader trend in urban management, where data-driven processes are used to enhance public safety and service delivery.

The Berlin Water Utility's laboratory will continue to play a crucial role in monitoring, analyzing, and ensuring the safety of drinking water in Berlin's public buildings. The adoption of new technologies and digital platforms is expected to further improve response times and overall water quality management in the city.

PRESS RELEASE: Spore.Bio Appoints Dr. Michael J. Miller as VP of Scientific & Regulatory Affairs to Advance Rapid Microbiology in Manufacturing QC

2026-01-29T07:33:00.002-05:00

Spore.Bio, a company at the intersection of AI, biophotonics, and microbiology, today announced that renowned microbiologist, Dr. Michael J. Miller has joined as Vice President of Scientific & Regulatory Affairs. His appointment marks yet another step in Spore.Bio’s mission to embed rapid, modern microbiology at the heart of pharmaceutical manufacturing and other highly regulated industries worldwide.

With nearly 40 years of experience in pharmaceutical microbiology, contamination control and the validation of rapid microbiological methods, Dr Miller has held senior and executive roles in Microbiology at Johnson & Johnson, Eli Lilly and Company, Bausch & Lomb.

He has served as an expert witness on numerous pharmaceutical and medical device patent and product liability cases, has advised the USP Microbiology Expert Committee, authored more than 100 technical publications and presentations, and serves on the editorial and scientific review boards for American Pharmaceutical Review, European Pharmaceutical Review, and the PDA Journal of Pharmaceutical Science and Technology. Through his consultancy, he now advises multinational companies on microbiology, quality, and regulatory affairs.

He is also chairperson for the revision of PDA Technical Report No. 33 - created to establish industry-wide criteria on what constitutes an acceptable alternative or rapid microbiology test - and provides an educational platform dedicated to the advancement of rapid microbiological methods through Rapid Microbiological Methods. At Spore.bio he will combine this experience and his regulatory skills and expertise to further strengthen the company's strategy as it scales.

“Bringing the biggest Key Opinion Leader of our field into Spore.Bio is a strong signal of where we’re headed as a company,” said Amine Raji, CEO, Spore.Bio. “His decades of experience in rapid methods, contamination control, and regulatory strategy give us exactly the kind of scientific and regulatory backbone we need as we scale and with Michael on board, we’re not just advancing our technology – we’re raising the bar for how it is validated, implemented and communicated to regulators, partners and customers. This is an important milestone for Spore.Bio, and it’s only the beginning of what we’ll be announcing in the weeks ahead.”

“Spore.Bio is tackling a problem I’ve spent my entire career thinking about: how to make microbiology faster, more reliable, and more actionable for manufacturers,” said Dr. Michael J. Miller, VP of Scientific & Regulatory Affairs at Spore.Bio. “The combination of AI, biophotonics, and microbiology Spore.Bio is building has the potential to redefine what ‘rapid methods’ mean. I’m excited to work with a firm that continues to set the standard for what a scientifically robust, validated and regulated platform can bring to users across pharma and beyond.”

PRESS RELEASE: En Carta Diagnostics receives FDA Breakthrough Device Designation for EC Pocket Lyme Test

2026-01-29T07:25:00.001-05:00

Image created by Dr. Michael J. Miller

En Carta Diagnostics, a deeptech start-up developing rapid Point-of-Needmolecular diagnostics kits, today announces that EC Pocket Lyme, its test for the early detection of Borrelia bacteria – the cause of Lyme disease – has received Breakthrough Device Designation (BDD) from the US Food and Drug Administration (FDA).

As a molecular assay with a visual result, EC Pocket Lyme is intended for the detection of Borrelia bacteria directly from skin interstitial fluid samples from individuals with signs of tick bites or erythema migrans (EM). The test is delivered in a single-use frugal cassette format designed for accuracy, affordability and accessibility, allowing easy large-scale distribution. The results will aid in the diagnosis of infections with Borrelia bacteria causing Lyme disease, in conjunction with clinical findings and other laboratory tests.

FDA Breakthrough Device Designation is reserved for technologies that have demonstrated the potential to provide more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases. Through this designation, the FDA will provide En Carta Diagnostics with a priority review and enhanced, interactive communication with FDA experts and senior leadership, supporting a more efficient path toward US commercialization.

“This Breakthrough Device Designation is a pivotal moment for us. It significantly strengthens our regulatory path by enabling closer collaboration with the FDA and accelerating our route to market, so patients can benefit from our technology sooner. The designation is also a powerful external validation of the quality, robustness and clinical relevance of our platform,” said Dr. Margot Karlikow, co-founder and CTO of En Carta Diagnostics.

Lyme disease, a tick-borne infection, remains one of the most challenging infectious diseases to diagnose at an early stage. Existing standard-of-care relies on visual diagnosis of a specific type of rash (erythema migrans or EM) and tests detecting the antibodies produced by the immune system in response to infection. However, EM can go unnoticed and antibodies become detectable only five to six weeks after a tick bite, rendering early-stage immuno-based testing impossible. If left undiagnosed or not treated early, Lyme disease can develop into acute illness and in rare cases can result in death.

EC Pocket Lyme is set to address this limitation with two innovative solutions. First, its microneedle-based sampler, that allows access to interstitial fluid right at the tick bite – unlocking a sample source previously inaccessible without an invasive biopsy. Second, its portable and precise molecular test designed to accurately detect Lyme disease-causing bacteria via DNA identification, before the immune response appears. People showing signs of a tick bite or a suspected EM will be able to rapidly determine whether they are at risk of Lyme disease.

The global prevalence of Lyme disease is most widespread in the Northern Hemisphere, and the number of cases has been steadily increasing for over 40 years. There are an estimated 476,000 new cases of Lyme disease in the US, annually.

New way of delivering fast and accurate Point-of-Need diagnostics

The EC Pocket Lyme platform is underpinned by more than a decade of intensive research and leverages aptamer-based technology, which enables high-affinity and high-specificity binding to predefined targets. These molecular ‘signatures’ can be programmed to detect a wide range of genetic, pathogenic and veterinary indications, opening the door to a broad pipeline of future applications beyond Lyme disease.

“From an investment perspective, this milestone de-risks our development program and enhances our credibility with regulators and partners. If approved, our diagnostics platform will be the first one to aid in the early detection of the bacteria responsible for Lyme disease. I am convinced our work will become a go-to solution for the 50 million people who see signs of a tick bite each year. I am immensely proud of our team, who transformed, in record time, frontier synbio technology into a robust and cost-effective product,” said Guillaume Horreard, co-founder and CEO of En Carta Diagnostics.

About En Carta Diagnostics

En Carta Diagnostics is a deep-tech startup creating Point-of-Need molecular diagnostics that are as easy to use as rapid tests, with the precision of a PCR machine. Its first product focuses on the early diagnosis of Lyme disease, a growing health challenge in the US and Europe with no effective solution currently on the market.

The company develops a patented molecular diagnostics platform with an exclusive worldwide license. Founded in 2022 by Harvard and Institut Pasteur alumni, En Carta Diagnostics has built five prototypes, published ten papers in scientific journals on the proof of concept on pathogens including Zika, chikungunya, Ebola and typhoid, and secured a commercial contract with a digital healthcare leader.

Its scientific team members received a $17.7M DARPA project award in 2023 and collaborate with an extensive network of research institutes in Latin America. The company also raised €1.5M in 2024 and reached clinical stage prior to receiving FDA breakthrough designation.

Located in Paris, France, En Carta Diagnostics is a Creative Destruction Lab (CDL) graduate, incubated at Paris Biotech Santé and 50 Partners Santé.

PRESS RELEASE: Diasorin, Thermo Fisher Ink US Distribution Pact for Rapid POC Molecular System, Respiratory Test

2026-01-27T07:15:00.002-05:00

Image created by Dr. Michael J. Miller

Diasorin announced today that, following the recent 510(k) clearance and CLIA-waiver from the U.S. Food and Drug Administration (FDA) for its first assay—the FLU A/B, RSV & COVID-19 Panel for use on the LIAISON NES® platform— the Company has entered into an exclusive distribution agreement with Fisher Scientific, part of Thermo Fisher Scientific, for the LIAISON NES® molecular point-of-care (POC) platform in the U.S. hospital market.

The LIAISON NES® is a next-generation molecular POC system designed to expand access to high-quality diagnostic testing in decentralized settings. Its fully automated workflow requires only a few seconds of hands-on time and delivers results in approximately 15 minutes, enabling timely clinical decisions while reducing dependence on specialized laboratory personnel.

The U.S. represents one of the largest global markets for molecular respiratory testing, with over 7,000 hospitals and approximately 130,000 POLs performing such diagnostics. Fisher Scientific’s strong footprint and established relationships across the hospital channel make it a strategic partner for the introduction and scale-up of the LIAISON NES® platform and its respiratory panel.

The agreement strengthens Diasorin’s commercial capabilities in the hospital segment, complementing the Company’s existing U.S. commercial organization, which today promotes Diasorin’s molecular solutions—including LIAISON® MDX and LIAISON® PLEX—as well as the recently expanded salesforce dedicated to the LIAISON NES® program.

“This agreement will accelerate our entry into the hospital segment and support access to major U.S. Integrated Delivery Networks (IDNs),” commented Carlo Rosa, CEO of Diasorin.

“We are also working to finalize additional distribution agreements with others in the United States aimed at providing full coverage of the non-acute market segment, which includes more than 130,000 POLs, ensuring a comprehensive and efficient go-to-market strategy across all key customer categories”.

PRESS RELEASE: New Deep Tech Startup Launches Rapid DNA Air Sequencing Technology, for Biological Threat Detection

2026-01-27T07:04:00.002-05:00

Image created by Dr. Michael J. Miller

The Natural History Museum, London and Earlham Institute, Norwich today announce a joint venture spin-out company Agnos Biosciences™ (the first of its kind in the Museum’s history). The Agnos Biosciences™ team developed the AirSeq™ technology which provides rapid detection of airborne pathogens, transforming capabilities for early pathogen detection.

This new technology is a method for characterising biological particles in the air using a combination of novel molecular biology, DNA sequencing and bespoke computational analysis. With a low false positive rate, it can be used to quantify the presence of bacteria, viruses, fungi, pollen or any other biological material. Unlike alternatives, AirSeq™ is unbiased, is not targeted to specific pathogens and can detect multiple (1000s) species.

Culminating years of scientific research and development funded by the Biotechnology and Biological Sciences Research Council and other public and philanthropic funding bodies in the UK and US, the AirSeq™ technology has a range of potential applications with proven results in environmental monitoring, agricultural pathogen detection, food manufacturing pathogen detection and monitoring - and biological threat detection following extensive research with the US DARPA (United States’ Defense Advanced Research Projects Agency).

Natural History Museum Research Leader and Agnos Biosciences’ Co-Founder and CSO Professor Matt Clark says: “AirSeq is the culmination of many years of research. We are very excited about how fast and accurate it is at detecting pathogens or indeed any organism via their DNA – identifying them in the air enables early, critical interventions hopefully preventing infections and pandemics taking hold.”

Earlham Institute Group Leader and Agnos Biosciences Co-Founder and CTO Dr Richard Leggett says: “I'm delighted to launch AirSeq as a service after so many years of research and development. This is an exciting opportunity to use this technology to help new customers with different applications, as well as develop AirSeq's continued use in agriculture, the wider food industry and in biosecurity.”

The Earlham Institute and Natural History Museum are licensing AirSeq technology to Agnos Biosciences™ which will enable the spinout to offer it as an end-to-end commercial service. The service includes air sampling, lab-based DNA extraction and sequencing, as well as bioinformatics analysis and web-based visualisation of results.

With the core technology (patented novel molecular biology methods and bioinformatics platform) prototyped, tried and tested, AirSeq™ is already being used by customers in the UK.

Natural History Museum Entrepreneur in Residence and Agnos Biosciences Co-Founder and CEO Simon Kim says: “We are excited to launch our dual-use venture Agnos Biosciences™, with its civil and defence applications. Our innovative AirSeq™ technology tackles a growing global health issue, the spread of pathogens and biological threats. With clients in agriculture, food manufacturing and academic research and applications in biosecurity and biopharma development it has clean room applications, even potentially in space!”

The dual-use spinout Agnos Biosciences™ is the first venture to launch from the Museum’s Strategy and Innovation Unit created in 2023 and is one of the first of its kind in the UK’s Culture sector.

Natural History Museum Director of Strategy and Innovation Bethan Parry says: “To create positive impact for the planet, society, and the economy, we need the research of the Natural History Museum’s 400 scientists to be used at scale. We have a number of exciting projects and patents in progress which include innovations around the way we extract the minerals needed to support the green economy through to new dyes and nutraceuticals which can replace toxic chemicals with natural alternatives that offer health benefits.”

At the Earlham Institute, scientists have contributed over a decade of research to AirSeq technology. Dr Liliya Serazetdinova, Head of Business Development and Impact at the Earlham Institute, says: “Agnos Biosciences is our second spinout company at the Earlham Institute; we truly believe in the importance of translating our cutting-edge science into real-world applications. It enables so many more lives to be transformed and we are delighted to work with the Natural History Museum on this joint venture.’’

PRESS RELEASE: Zepto Launches Mold Panel to Accelerate Diagnosis of Invasive Fungal Infections

2026-01-22T06:14:00.003-05:00

Image created by Dr. Michael J. Miller

Zepto Life Technology announced the launch of the FungiFlex Mold Panel, a plasma-based molecular diagnostic test now available through its CLIA-certified reference laboratory. The new offering expands access to faster, noninvasive testing for patients at risk of invasive fungal infections (IFIs), a group of diseases that remain difficult to diagnose with current standard methods.

“Delayed diagnosis remains one of the biggest challenges in managing invasive fungal infections,” Zepto Life Technology CEO Hannah Zhang said in a statement. “By launching FungiFlex as a reference laboratory test, we are making this targeted approach available today, while advancing a platform designed for rapid deployment closer to patient care.”

The FungiFlex Mold Panel detects fungal cell-free DNA (cfDNA)—small fragments of DNA circulating in the bloodstream—from a single plasma sample. The test is designed to identify 21 clinically important mold species, including major pathogens such as Aspergillus and Mucorales, which are responsible for some of the most severe and life-threatening fungal infections. Using Zepto’s fully automated, sample-to-result system, results are typically available within approximately 24 hours of sample receipt.

While the panel is initially being offered as a reference laboratory test, it represents the first clinical deployment of Zepto’s targeted, rapid, and deployable liquid biopsy platform for infectious disease diagnostics. The launch marks a key commercial milestone for the company and serves as an early step toward broader, decentralized clinical use of its technology in the future.

Invasive mold infections are among the most challenging fungal diseases to diagnose. Filamentous fungi grow slowly in culture, often requiring days to weeks before results are available. In many cases, diagnosis depends on invasive and costly procedures such as tissue biopsy or bronchoalveolar lavage, which may still fail to yield definitive results. These delays can have serious consequences, particularly for immunocompromised patients, for whom invasive fungal infections are associated with high mortality rates.

A targeted, blood-based molecular approach offers a promising alternative. By detecting fungal DNA directly from plasma, clinicians may gain earlier insight into the presence of invasive mold infections without relying on invasive sampling procedures. Earlier detection can support more timely treatment decisions and potentially improve patient outcomes.

The FungiFlex Mold Panel is intended for patients who show symptoms of invasive fungal disease or who have medical conditions that place them at higher risk. This includes individuals undergoing organ or stem cell transplantation, as well as patients receiving immunosuppressive therapies for cancer, autoimmune disorders, or other conditions. All samples are processed at Zepto Life Technology’s CLIA-certified laboratory in St. Paul, Minnesota, ensuring compliance with federal quality and regulatory standards.

Looking ahead, Zepto aims to expand the clinical reach of its liquid biopsy platform beyond invasive fungal infections. The company’s technology is designed to deliver clinically actionable results from a simple blood draw and to scale across additional infectious disease indications, potentially transforming how complex infections are diagnosed and managed.

Zepto Life Technology is a molecular diagnostics company focused on developing rapid, deployable liquid biopsy platforms for infectious disease. Beginning with invasive fungal infections, the company aims to provide clinicians with faster, less invasive diagnostic tools that can improve patient care and support better clinical decision-making.

PRESS RELEASE: Cepheid Receives FDA Clearance for Xpert® GI Panel to Support Broad Detection of Gastrointestinal Pathogens

2026-01-22T05:50:00.000-05:00

Image created by Dr. Michael J. Miller

Cepheid announced today that it has received FDA clearance for Xpert GI Panel, a multiplex PCR test designed to provide fast and accurate detection of 11 clinically relevant gastrointestinal (GI) pathogens from a single patient sample. Leveraging Cepheid's advanced 10-color multiplexing technology on its GeneXpert® systems, the test offers a robust solution to simplify GI testing workflows and deliver meaningful answers to clinicians.

Cepheid's Xpert GI Panel simultaneously detects and identifies 11 important bacterial, viral, and parasitic pathogens directly from stool specimens in Cary-Blair transport media. The streamlined workflow requires less than one minute of hands-on time, delivering results in approximately 74 minutes.

Patient and Public Health Impact of GI Pathogens

Gastrointestinal infections are a common cause of illness worldwide,[1] with an estimated incidence of 179 million cases of acute gastroenteritis annually in the United States.[2] These infections can be caused by a wide range of pathogens—including bacteria, viruses, and parasites—and often present with overlapping symptoms such as diarrhea, abdominal pain, and fever that make diagnosis challenging.[3] Rapid and accurate identification of the causative agent is critical for guiding appropriate treatment in high-risk patients and can aid in reducing the risk of outbreaks in healthcare and community settings.[3]

Traditional diagnostic methods, such as stool culture, can be time-consuming, labor-intensive, and may miss co-infections or low-abundance pathogens.[4, 5] Multiplex molecular testing offers a faster, more comprehensive approach by simultaneously testing for multiple pathogens. This equips clinicians to make informed decisions quickly and potentially improves patient outcomes.

"The Xpert GI Panel is designed to help healthcare providers identify the cause of infectious diarrhea acquired in the community," said Dr. Connie Savor, Chief Medical Officer at Cepheid. "By focusing on the most common causative pathogens, we've created a panel that balances clinical relevance with operational efficiency."

Multiplex Technology Expands What GeneXpert Systems Can Detect

The test will run on Cepheid's widely adopted GeneXpert systems equipped or upgraded with 10-color modules that enable simultaneous detection of 10 or more pathogens or biomarkers.

"Multiplex panels on the GeneXpert system deliver healthcare providers the versatility to do even more for their patients who need answers quickly —from targeted single-pathogen tests to broader multiplex tests on a single platform," said Vitor Rocha, President of Cepheid.

Expanding Access to High‑Quality Diagnostics

The new Xpert GI panel test underscores Cepheid's commitment to improving access to high-quality diagnostics in both inpatient and outpatient settings. It complements Cepheid's existing GI solutions portfolio, which includes standalone PCR tests for Clostridioides difficile and Norovirus. The Xpert GI Panel will begin shipping to U.S. customers in the coming weeks.

US-IVD. In Vitro Diagnostic Medical Device.

References:

Wang Y et al., 2023. Global Burden of Digestive Diseases: A Systematic Analysis of the Global Burden of Diseases Study, 1990 to 2019. Gastroenterology, Volume 165, Issue 3, 773 - 783.e15
CDC Emerging Infectious Diseases. Volume 28, Number 11, November 2022. Incidence, Etiology, and Healthcare Utilization for Acute Gastroenteritis in the Community, United States. https://wwwnc.cdc.gov/eid/article/28/11/22-0247_article Accessed January 2026.
Shane AL et al., 2017. 2017 Infectious Diseases Society of America Clinical Practice Guidelines for the Diagnosis and Management of Infectious Diarrhea, Clinical Infectious Diseases, Volume 65, Issue 12, 15 December 2017, Pages e45–e80, https://doi.org/10.1093/cid/cix669
Mehravar S 2023. Diagnostic Tools for Detecting Gastrointestinal Infections. International Foundation for Gastrointestinal Disorders Fact Sheet. https://iffgd.org/wp-content/uploads/280-Diagnostic-tests-for-GI-infections.pdf Accessed January 2026.
Testing.com Medical Review Board. 2021. Gastrointestinal Pathogens Panel. https://www.testing.com/tests/gastrointestinal-pathogens-panel/ Accessed January 2026.

PRESS RELEASE: ShanX Medtech Secures Funding to Accelerate Development of Ultra-Rapid Antimicrobial Susceptibility Diagnostics

2026-01-13T11:31:00.002-05:00

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ShanX Medtech B.V. (SXM), an innovative startup transforming how microbial infections are managed with its novel In-Vitro Diagnostic (IVD) platform, announces the closing of an oversubscribed EUR 15 million (~USD 17,5 million) seed funding round. The round combines multiple funding instruments including equity, grants and the Innovatiekrediet. The equity investment is led by the Borski Fund, NextGen Ventures, CbusineZ - an independent investment fund closely associated with healthcare insurer CZ -, Brabantse Ontwikkelings Maatschappij (BOM), Invest-NL, and a prominent strategic angel fund.

This financing is further complemented by the recently awarded EUR 8,85 million (~USD 10,4 million) European Commission Contract (HADEA/2025/CPN/0006), developed by the Health Emergency Preparedness and Response Authority (DG HERA) in collaboration with the European Health and Digital Executive Agency (HADEA), bringing the total financing to EUR 24 million. The innovation addresses one of the most urgent challenges in global healthcare today: the escalating threat of antimicrobial resistance (AMR). The obtained funding accelerates the final development, clinical validation, regulatory approval, and commercial launch of the SXM diagnostic platform, which is already seeing heavy interest from healthcare and commercial partners.

ShanX Medtech is transforming infection care with ultra-rapid, direct-from-sample antimicrobial susceptibility testing (AST). Using novel chemistry to monitor microbial metabolism, SXM delivers comprehensive results within an hour with minimal user involvement, representing a breakthrough improvement over current methods, which require multiple trained technicians and take days to yield actionable results. By enabling faster, evidence-based treatment decisions in both laboratory and point-of-care settings, the platform has the potential to improve patient outcomes, reduce healthcare costs, curb the spread of AMR, and strengthen pandemic preparedness.

“We founded ShanX Medtech because of a single patient story, one that revealed how much is at stake when diagnostic results arrive too late,” said Dr. Sophia E. Shanko, Founder and CEO of ShanX Medtech. “Our vision is to equip every clinician with the ability to act decisively, guided by diagnostic evidence in real-time. This funding brings us significantly closer to delivering ultra-rapid AST directly to both laboratory and point-of-care environments; faster, simpler, and more accessible than ever before.”

“Borski Fund is pleased to announce our investment in Eindhoven-based ShanX Medtech,” said Simone Brummelhuis, Partner at Borski Fund. “Following an extensive market analysis of innovations addressing antimicrobial resistance, ShanX’s technology clearly emerged as best-in-class. While the company’s initial go-to-market strategy focuses on a well-defined women’s health application in urinary tract infections, the underlying platform offers substantial potential across a wide range of clinical indications.

We are proud to support Sophia and her exceptional team in realizing their ambitious vision. The oversubscribed financing round, together with multiple multi-million-euro commercial contracts, underscores both the strength of the technology and the founder’s proven commercial execution.”

“Antimicrobial resistance represents one of the most critical unmet needs in global healthcare, with few effective solutions available today,” said Paul Vernooij, Investment Manager at Brabant Development Agency (BOM). “ShanX Medtech introduces a highly innovative technology that contributes preventively to global health. As an early-stage investor, BOM is proud to take this next step alongside such a pioneering company.”

About ShanX Medtech

Founded in 2019, ShanX Medtech is a Dutch company based at the High Tech Campus in Eindhoven, The Netherlands. The company develops innovative In-Vitro Diagnostic (IVD) solutions that deliver ultra-rapid and accessible antimicrobial susceptibility testing, supporting global efforts to combat AMR and improve public health.

With 350+ MedTech companies and responsible for 90% of Dutch MedTech patents, the ecosystem in Eindhoven combines world-class research, advanced manufacturing, and entrepreneurial drive to accelerate healthcare solutions from idea to market.

PRESS RELEASE and VIDEO: Spore.Bio Selected by the Google.org AI for Science Fund to Advance its Biophotonics and AI Deep learning Platform; Launches Spore.Labs, its AI-Native Fundamental Research Center

2026-01-08T10:16:00.005-05:00

Spore.Bio, a Paris-based deeptech company, today announces a major multi-million dollar funding from the Google.Org Fund for AI in Science, and the launch of Spore.Labs, a new fundamental AI-native research division to tackle the most pressing challenges in Public Health.

Following the recent award to Demis Hassabis and John Jumper of the Nobel Prize (® the Nobel Foundation) in Chemistry, for AlphaFold’s contributions to protein structure prediction, Google.org announced the creation of a major fund to support academic and nonprofit organizations around the world that are using AI to address increasingly complex problems at the intersections of different disciplines of science.

Spore.Bio is the only startup in the world selected by the Google.org AI for Science Fund to tackle this challenge, placing the company at the forefront of global efforts in Public Health and giving major resources to fight the microbial challenges of the Twenty-First Century.

Spore.Labs represents a new model for microbiology research, bringing together AI researchers, microbiologists, and photonics engineers in a collaborative environment designed to unlock fundamentally new understanding of microbial behavior. By combining advanced biophotonics with machine learning, the platform captures and analyzes how micro-organisms behave, evolve, and develop resistance at unprecedented resolution and speed.

Spore.Labs’ research will drive innovations in diagnostic technologies, industrial biomonitoring, and environmental health applications, with the potential to transform how we detect and respond to microbial threats. By making microbial testing faster, more accurate, and intelligence-driven, the lab's work promises to accelerate breakthroughs that protect public health and industrial safety.

"Spore.Labs embodies our vision of what microbiology research should look like in the AI era," said Amine Raji, CEO of Spore.Bio. “With support from Google.org, we're creating a research environment where the boundaries between biology, physics, and computer science dissolve, allowing us to see and understand microbes in ways that were previously impossible."

With consequent funding and Google Cloud Platform credits from Google.org, Spore.Labs will develop open datasets, publish research findings, and collaborate with academic and clinical partners to validate its approaches. The lab has opened 15 scientists positions in Microbiology, Photonics and Deep Learning, and will hire 30 scientists by the end of 2026.

About Spore.Bio

Spore.Bio is a Paris-based biotech company transforming microbiology through the convergence of photonics, hardware engineering, and artificial intelligence. The company develops intelligent full stack platforms that enable industries and healthcare systems to monitor and understand microbial life with unprecedented speed, accuracy, and insight. By making microbial testing faster, more reliable, and data-driven, Spore.Bio's technology contributes to safer products, cleaner environments, and more resilient public health systems. Spore.Bio has raised 35M$ to date.

About the Google.org AI for Science Fund

The Google.org AI for Science Fund is a multi-million initiative supporting organizations at the forefront of AI-driven scientific discovery, awarding grants to academic institutions, nonprofit and for-profit organizations worldwide applying artificial intelligence to solve complex challenges across scientific disciplines.

WHO Prequalifies the First Two Rapid Antigen Detection Tests for COVID-19

2025-12-25T10:37:00.000-05:00

Image created by Dr. Michael J. Miller

On 17 December 2025, the World Health Organization (WHO) announced the prequalification of two rapid antigen diagnostic tests (Ag-RDT) for SARS-CoV-2, the virus that causes COVID-19. The two tests are the SD Biosensor STANDARD Q COVID-19 Ag Test and the ACON Biotech Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing). This marks the first time that rapid antigen tests for SARS-CoV-2 have achieved WHO prequalification.

This achievement builds on earlier regulatory milestones for these products previously listed under WHO’s Emergency Use Listing (EUL). In September 2020, the SD Biosensor STANDARD Q COVID-19 Ag Test became the first rapid antigen test ever listed under WHO’s EUL, enabling its rapid deployment across more than 100 countries during the COVID-19 pandemic. WHO EUL is a risk-benefit assessment, designed to accelerate access to life-saving health products during public health emergencies, based on limited available data where the benefits outweigh the risks.

The new WHO prequalification now provides long-term quality assurance, confirming that the products meet WHO standards for quality, safety and performance. It also makes these Ag-RDTs eligible for procurement by United Nations agencies, global health partners and countries, expanding access to rapid, reliable diagnostic tests in low- and middle-income countries (LMICs). The test can be prioritized in pooled procurement initiatives aimed at reducing prices and improving supply stability in LMICs, ultimately helping countries overcome barriers to accessing high-quality diagnostic tests due to cost, supply and regulatory constraints.

Two and a half years after WHO announced the end of the emergency phase of COVID-19, the virus continues to circulate worldwide, though current evidence indicates relatively stable trends of SARS-CoV-2 activity. The need for affordable, accurate diagnostic tools remains strong, especially in the world’s lower income countries where access to laboratory testing is limited.

Rapid antigen-detection tests provide results in 15–30 minutes, are affordable, and can be used outside centralized laboratories – in clinics, community sites and mobile settings – making them critical for timely detection of infectious cases and targeted public-health action. They are a vital complement to molecular (polymerase-chain reaction or PCR) tests, particularly in resource-limited settings with limited laboratory capacity.

Rapid antigen testing remains essential for:

detecting and controlling local outbreaks
protecting vulnerable populations and health-care workers
maintaining preparedness for future respiratory pandemics.

WHO’s broader diagnostics strategy highlights the ongoing need for decentralized, quality-assured testing as part of universal health coverage and global health-security efforts.

About WHO prequalification and EUL

For many years, the WHO Prequalification programme has been crucial in speeding up access to health products in LMICs by assessing their quality, safety, and effectiveness. It enables multilateral organizations to purchase quality-assured medicines, vaccines, diagnostic tools, and vector control products, while also providing guidance to developing regulatory authorities that may not yet have the resources to perform their own evaluations. Through its Emergency Use Listing (EUL), WHO prequalification conducts risk-based assessments of products during public health emergencies of international concern to meet urgent public health needs.

PRESS RELEASE: ImpetusDX Unveils Rapid Oral Microbial Test as Dental Practices Race to Catch Rising Rates of Gum Disease

2025-12-17T06:49:00.001-05:00

Image created by Dr. Michael J. Miller

With periodontal disease affecting more than four in ten American adults and growing evidence connecting oral bacteria to conditions such as cardiovascular disease, diabetes, and pregnancy complications dental teams are searching for faster, clearer ways to diagnose what traditional exams often miss. ImpetusDX is stepping into that need with the launch of its IDX Oral Health Microbial Testing panel, a rapid, DNA-based saliva test that detects high-risk periodontal pathogens in as little as 24 hours and easily fits into routine hygiene visits.

“Our panel is versatile and can be integrated into existing hygiene, periodontal maintenance, or surgical planning,” said Michelle Moore, CEO of Physicians Choice Labs, which powers the ImpetusDX platform. “The sample can be collected chairside during routine cleanings and exams, or as a diagnostic tool when an infection is suspected. Collection is noninvasive and only takes minutes, so it becomes a natural part of patient intake without disrupting the schedule.”

The ImpetusDX test moves beyond visual cues and probing depths by using PCR technology to identify the exact bacteria driving infection, including several emerging pathogens not yet covered by competitor panels. Clinicians receive a color-coded, semi-quantitative report within 24 to 48 hours, giving teams a faster and more targeted way to diagnose periodontitis, plan treatment, and track changes over time. With overnight shipping and Monday samples resulting by Tuesday, the turnaround is among the fastest available.

Key features of the ImpetusDX Oral Health Microbial Testing panel include:

DNA-based detection of high-risk periodontal pathogens, including emerging organisms such as Selenomonas noxia, Filifactor alocis, Pseudomonas aeruginosa, and Streptococcus mutans, providing a four-pathogen advantage over many competing tests.
Seamless integration into daily workflow. The test fits naturally into hygiene visits, periodontal-maintenance appointments, surgical planning, and functional or preventive medicine evaluations.
Rapid, reliable results with overnight shipping and 24–48-hour reporting; Monday samples result by Tuesday.
CAP-accredited, CLIA-certified laboratory processing and participation in the American Dental Association.
A simple six-step process that moves from chairside collection to clear, data-backed treatment pathways and retesting.

“Our panel is positioned to deliver results in under 48 hours, provide a broader oral–systemic view beyond traditional periodontal testing, and include real clinical support for easy integration into routine care,” Moore said. “We’re one of the only companies with representatives who will come onsite to help teams adopt the workflow and support doctors hands-on. Between CE credits, education forums, hygienist incentive programs, and pilot initiatives, we’re focused on building confidence and making the test a natural part of everyday patient care.”

Clinicians adopting the test report clearer treatment pathways, stronger patient acceptance, and a deeper understanding of the microbial drivers behind periodontal disease. Objective PCR data provides clarity that visual signs alone cannot, helping teams distinguish inflammation from active bacterial burden and illustrating the oral–systemic connection for patients. Many practices see meaningful financial growth after integrating the test, often reporting increased production within the first year and a significant rise in annual net revenue.

Looking ahead, ImpetusDX plans to expand its presence in dental school programs, grow state-by-state availability, and continue strengthening its CE-accredited education. As oral-microbiome research evolves, the company anticipates adding new microbial targets or biomarkers to further deepen its clinical value.

Indonesia's BRIN Color Sensor Can Rapidly Detect Tuberculosis

2025-12-04T11:57:00.006-05:00

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The research team of the Indonesian National Research and Innovation Agency (BRIN) has develop a way of detecting tuberculosis (TB) by using a colorimetric sensor to develop a rapid TB detection tool.

Ni Luh Wulan Septiani, a researcher in the team, stated that the colorimetric sensor possesses unique optical properties from silver nanoparticles, particularly triangular prism-shaped particles, with surface plasmon resonance (SPR) characteristics.

"This system works by inducing a color change when the biomarkers of the TB-causing bacteria are detected," said Ni Luh Wulan on BRIN's official website on Tuesday, December 2, 2025.

Materials with specific SPR can change color when their environment conditions change. Triangular-shaped silver nanoparticles have a blue color in a solution and are very sensitive. "If the environment changes, their shape can become round and the solution color turns yellow," said Ni Luh Wulan.

The properties of the nanoparticles were then modified. The research team attached specific TB receptors to the surface of triangular-shaped nanoparticles. When TB biomarkers are present in the sample, the receptors keep the particles in their triangular shape, and their color remains blue. On the other hand, when the sample does not contain TB, the particle shape changes and the color fades to yellow.

The blue color is interpreted as a positive sign of TB. "This color change happens very rapidly, within one to two minutes, making it possible to see whether the TB biomarkers are present or not," said Wulan.

During the testing process of the detection tool, the team used commercial protein sputum samples that were imported. Authentic sputum samples were obtained through collaboration with universities that have health facilities.

Through this research involving the Bandung Institute of Technology (ITB) and Airlangga University, BRIN researchers aim to complement the current standard TB detection procedure, which still relies on bacterial culture tests. This method is considered accurate but time-consuming. Meanwhile, the World Health Organization's recommendation for rapid detection within two hours based on molecular tests is still expensive.

The team seeks to offer the advantage of obtaining detection results within one minute. The results can be directly observed without the need for a complete laboratory, only requiring a small tube, a colorimeter device, and a smartphone. This simple detection method is considered ideal for community health centers and regional health services.

As the research is still in the laboratory stage, Wulan mentioned that it still needs to undergo accuracy testing, so there are no definitive figures yet. However, she is optimistic that the accuracy of this detection can compete with other rapid tests. The silver nanoparticle-based colorimetric TB sensor is targeted to become an early screening solution to help healthcare workers recognize TB more quickly.

PRESS RELEASE: FDA Clears Rapid Bordetella PCR Test

2025-12-04T11:34:00.001-05:00

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Roche reported that its first point-of-care assay for diagnosing whooping cough and other Bordetella infections received US Food and Drug Administration 510(k) clearance with a Clinical Laboratory Improvement Amendments waiver, along with CE IVDR certification. The polymerase chain reaction–based test, designed for use on the cobas liat system, generates results in 15 minutes. This turnaround enables physicians to diagnose patients during the visit and take prompt action, including providing appropriate antibiotics.

Pertussis continues to pose a global health burden, with an estimated 24.1 million cases and 170,000 deaths annually in children younger than 5 years. Early manifestations often resemble other respiratory infections, leading to empiric treatment and delayed confirmation. Such delays may permit disease progression.

The assay identifies and differentiates three clinically relevant species: Bordetella pertussis, the primary cause of classic pertussis; Bordetella parapertussis, which produces a similar but often milder illness with variable response to standard therapy; and Bordetella holmesii, an emerging pathogen associated with pertussis-like presentations and diagnostic complexity. Rising case numbers have been reported, consistent with the disease’s 3- to 5-year cyclical pattern. Recent increases may be driven by disruptions in routine vaccination during the pandemic period, waning immunity, and vaccine hesitancy, contributing to broader age-range susceptibility and atypical symptom patterns in older patients.

The cobas liat system is already used in point-of-care settings worldwide for respiratory diagnostics. It delivers polymerase chain reaction–level accuracy in 20 minutes or less and supports assays for SARS-CoV-2, influenza A, influenza B, respiratory syncytial virus, and group A Streptococcus.

PRESS RELEASE: Zymo Research Advances Wastewater Surveillance as Sponsor of the Microbes in Wastewater Symposium 2026

2025-12-02T08:29:00.002-05:00

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Zymo Research Corporation, a global leader in molecular biology and pathogen detection, is proud to sponsor the Microbes in Wastewater Symposium 2026, taking place January 15–16, 2026, at the Balboa Bay Resort in Newport Beach, California. The annual event brings together leading researchers, government agencies, and industry partners to advance scientific understanding and collaboration in wastewater-based epidemiology and microbial surveillance.

Hosted by the Aladdin Bioinformatics Foundation, Columbia University, The University of North Carolina at Chapel Hill, Los Angeles County Sanitation District, and SCCWRP, the 2026 symposium will highlight cutting-edge molecular and next-generation sequencing technologies driving progress in pathogen and antimicrobial resistance monitoring. This year's keynote speakers include Dr. Bruce E. Rittmann, Professor of Environmental Engineering and Director of the Biodesign Swette Center for Environmental Biotechnology at Arizona State University and Dr. Joan B. Rose, Nowlin Chair in Water Research and Director of the Water Alliance at Michigan State University, both internationally recognized pioneers in environmental biotechnology and water research.

"Having served as a keynote speaker at last year's symposium, I'm excited to help organize the 2026 event and continue advancing this important field," said Dr. Kartik Chandran, Professor of Environmental Engineering at Columbia University. "The Microbes in Wastewater Symposium has quickly become a cornerstone for collaboration in wastewater microbiology, bringing together leading scientists, engineers, and public health professionals to share insights, strengthen AMR and pathogen surveillance, and shape the future of wastewater science."

"Zymo Research's partnership helps make this symposium possible" said Dr. Annabelle Damerum, Program Director at the Aladdin Bioinformatics Foundation. "Their support allows us to convene a broad community of researchers and practitioners to advance wastewater microbiology, AMR monitoring, and next-generation sequencing surveillance approaches. Their ongoing commitment to developing high-quality molecular tools strengthens the impact of these discussions and accelerates progress in public health."

Zymo Research has been at the forefront of microbiome research for years, applying their expertise to wastewater analysis during the COVID-19 pandemic. As a company, Zymo Research has consistently championed workflow standardization, a crucial step toward improving wastewater surveillance.

To support researchers, Zymo Research offers industry-leading solutions, including:

Quick-DNA/RNA™ Water Kit: Extracts and purifies total DNA/RNA from large volume water samples, concentrating viruses and low-abundance targets while removing inhibitors, including from raw influent wastewater.
Wastewater Sample Collection Bottle: Features a stabilization buffer that preserves sample integrity for up to 7 days at ambient temperatures, inactivating pathogens, and simplifying transportation and storage.

Attendees are invited to visit Zymo Research's booth to connect with experts and explore innovative solutions in pathogen detection, antimicrobial resistance surveillance, and microbiome analysis.

For registration details, visit www.wastewateramr.com.

PRESS RELEASE: Nanopath Granted FDA Breakthrough Device Designation for Its Molecular Diagnostic Platform for Urinary Tract Infections

2025-12-02T08:27:00.000-05:00

Image created by Dr. Michael J. Miller

Nanopath, a point-of-care diagnostics company enabling high-quality molecular testing in minutes, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for the company's novel assay for the rapid detection of infection in patients with suspected, or at risk of, complicated urinary tract infections (UTIs).

This designation recognizes Nanopath's potential to significantly improve patient outcomes by delivering actionable molecular results within a single office visit and empowering healthcare providers and patients to make informed treatment decisions at the point-of-care. It also represents a major regulatory milestone, providing Nanopath with an accelerated pathway toward FDA marketing authorization and commercial launch.

"Receiving Breakthrough Device designation is an exceptional recognition of Nanopath's technology and its potential to transform how UTIs are diagnosed," said Amogha Tadimety, Ph.D., co-founder and co-chief executive officer of Nanopath. "It is incredibly rare for a diagnostic test – particularly in microbiology and women's health – to receive this distinction."

"This recognition and commitment from the FDA underscores the strength and innovative nature of our platform. It also marks an important step toward realizing our vision of making rapid molecular diagnostics broadly accessible in clinical settings worldwide," said Alison Burklund, Ph.D. co-founder and co-chief executive officer of Nanopath.

The First Molecular Platform for cUTI Diagnosis at the Point-of-Care

Complicated UTIs (cUTIs) are among the most common infections worldwide, representing a major, highly underserved disease space and a multi-billion-dollar global market opportunity. Nanopath is developing the first molecular diagnostic platform capable of simultaneously identifying cUTI-causing pathogens and key antibiotic resistance markers at the point-of-care, in approximately 15 minutes, directly from a urine sample.

Unlike existing culture-based, laboratory-scale tests that can take several days to return a result, Nanopath's cartridge-reader solution is designed to deliver actionable diagnostic insights during an office visit. This enables clinicians to rapidly initiate appropriate therapy faster and avoid unnecessary or ineffective antibiotic use.

"No existing test today can provide this level of molecular insight for complicated UTIs during a patient encounter. Nanopath's easy-to-use platform will report clear, actionable results, so that patients no longer have to wait days in pain before beginning targeted treatment," said Edward Evantash, MD, chief medical officer of Nanopath.

The FDA's Breakthrough Devices Program is a voluntary initiative designed to accelerate the development, assessment and review of a select group of medical devices that may offer more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions. The designation enables Nanopath to engage in early, frequent interactions with the FDA to support a clear pathway to commercialization.

"For too long, patients have waited days or even weeks for critical test results," said Jeff Crowe, senior managing partner at Norwest. "Nanopath is transforming diagnosis and care delivery by providing faster, more reliable results that clinicians can act on. With this FDA Breakthrough Device designation, the company is poised to scale its impact and growth in an area that desperately needs innovation."

Last month Nanopath announced expansion of the company's leadership team with five executives hired to fuel the company's scientific and commercialization growth.

PRESS RELEASE: OCEAN Dx Rapid Diagnostic Test for Sepsis Matched Gold Standard During a Clinical Evaluation Study

2025-11-26T05:59:00.001-05:00

Image created by Dr. Michael J. Miller

OCEAN Dx, a pioneer in rapid diagnostic solutions, announced the successful completion of a clinical evaluation study for its innovative rapid diagnostic test for sepsis. Conducted by Dr. Antoine Dewitte’s team in the Intensive Care Unit (ICU) of Bordeaux University Hospital, the study involved 107 patients and achieved results consistent with the gold standard for sepsis detection. This breakthrough marks a milestone in OCEAN Dx’s mission to provide clinicians with fast, accurate, and life-saving diagnostic tools. By improving patient triage, supporting treatment decisions, enhancing antibiotic management (including de-escalation), and helping to prevent antibiotic resistance, this test has the potential to revolutionize sepsis care worldwide.

The clinical evaluation study delivered outstanding results from 237 blood samples. The test, which features an impressive detection spectrum covering over 1,000 bacterial species, provided results within a 5-hour turnaround time. It achieved 100% detection sensitivity and 100% negative predictive value (NPV) compared with the reference blood culture test and demonstrated a strong concordance in bacterial identification with mass spectrometry, 95% at phylogenetic family level and 85% at the species level. Presented at Sepsis Update 2025, results showed 95% true positives versus blood culture, with detection of fastidious bacteria and resilience to antimicrobial inhibition; scientific publication forthcoming.

“In our study, the test detected nearly three times more bloodstream infections than conventional blood cultures, with perfect sensitivity and negative predictive value, and results available very quickly”, said Dr. Antoine Dewitte, principal investigator at Bordeaux University Hospital.

“We are pleased to announce that our sepsis rapid diagnostic test evaluation study has been a success, with an excellent average time-to-result of just 5 hours, that we expect to decrease to 3.5 hours. This is a great improvement since the detection and identification of sepsis-causing pathogens using blood cultures typically takes between 2 and 6 days”, commented Franck Tarendeau, CEO of OCEAN Dx.

OCEAN Dx is completing the industrialization of its sepsis test and plans clinical trials in 2026, targeting CE marking. OCEAN Dx will launch its rapid sepsis diagnostic test in Europe by 2029.

ABOUT OCEAN Dx:

Created in 2019, OCEAN Dx is a start-up specialized in vitro diagnostics of infectious diseases. OCEAN Dx is a deeptech company in the field of healthcare. The company was the winner of the i-Lab 2020 Competition and the i-Nov 2020 Competition.