Diagnostics Product Guide

Cepheida receives approval for its bacterial diagnostic test

Jim Marino — Tue, 14 Jul 2009 04:19:36 +0000

Molecular-diagnostic company Cepheid has received the Food and Drug Administration (FDA) approval for a test that helps in rapid diagnosis of a bacteria linked to antibiotic-resistant infections. Cepheid’s Xpert C.difficile test can detect within 45 minutes a bacterium that causes the Clostridium difficile infection, resulting in diarrhea and more serious intestinal conditions, such as colitis.

HemoPoint H2 Hemoglobin DMS of Stanbio approved

Jim Marino — Tue, 07 Jul 2009 05:26:33 +0000

Stanbio Laboratory announced that the FDA has approved its HemoPoint H2 Hemoglobin Data Management System (DMS), which provides both a hemoglobin and calculated hematocrit result with one simple test. The new, HemoPoint H2 DMS utilizes connectivity to PCs via Bluetooth, control intervals and barcode identification of operators and patients to offer time-saving convenience, ease of data management technology and high quality control.

Medtronic’s Attain Ability approved

Jim Marino — Tue, 07 Jul 2009 05:11:29 +0000

Medtronic Inc announced the approval of its Attain Ability left-heart lead (Model 4196) by the U.S. Food and Drug Administration (FDA) for use with cardiac resynchronization therapy (CRT) devices for heart failure patients. Attain Ability has the thinnest lead body of any left-heart lead currently available, providing physicians with a tool to deliver therapy directly to hard-to-reach areas of the heart.

VITROS(R) 3600 Immunodiagnostic System Receives 510(k) Clearance From The FDA

Jim Marino — Fri, 02 Jan 2009 08:46:02 +0000

Ortho Clinical Diagnostics announced 510(k) clearance from the United States Food and Drug Administration (U.S. FDA) for its VITROS(R) 3600 Immunodiagnostic System. This new high-capacity immunoassay system provides laboratories with a truly innovative solution to address their quality, labor and cost challenges. The VITROS(R) 3600 delivers high-quality and dependable results by offering a broad and comprehensive immunoassay menu based on world-class VITROS(R) technologies. This is the second clearance for Ortho Clinical Diagnostics this quarter, following 510(k) clearance of the VITROS(R) 5600 Integrated System in October.

Studies show novel device may enhance chemotherapy treatment in brain tumors

Jim Marino — Wed, 17 Dec 2008 11:50:21 +0000

NovoCure Ltd has evaluated the Novo-TTF device in vitro and in a pilot clinical trial that showed the device enhanced the efficacy of standard chemotherapy (temozolomide) treatment in newly-diagnosed glioblastoma multiforme (GBM) patients. When used in combination with standard chemotherapy, the Novo-TTF, a non-invasive medical device that uses low intensity alternating electric fields to destroy cancer cells, enhanced the anti-tumor effects of standard chemotherapy, thus prolonging time to disease progression and extending survival. Patients in the study did not experience any device-related, systemic, adverse events.

Asuragen Initiates Launch of CE-Marked Molecular Diagnostic Products

Jim Marino — Tue, 09 Dec 2008 06:27:14 +0000

Asuragen, Inc. has announced that the Signature(R) LTx v2.0 Leukemia Translocation Panel was released as a “Conformite Europeenne” or “European Conformity” CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The CE-marked Signature(R) LTx v2.0 is a qualitative in vitro diagnostic device for use in a clinical laboratory to identify specific fusion transcripts in total RNA from whole blood or bone marrow to aid in the clinical diagnosis of translocation positive leukemias. Clinical validation studies showed 100% diagnostic accuracy in comparison to standard cytogenetic methods. This represents the world’s first Luminex-based molecular oncology IVD product.

World’s fastest CT scanner hits the market in 2009

Jim Marino — Fri, 28 Nov 2008 09:31:49 +0000

Siemens Healthcare has launched a NEW-GENERATION, superfast CT scanner that requires only a fraction of the radiation dose usually used in imaging techniques . The SOMATOM Definition Flash is a dual source device featuring two x-ray tubes which simultaneously revolve around the patient’s body, scanning even the tiniest anatomical details at a faster speed than ever before and with a much lower dose of radiation. The scanner can check the entire heart in just 250 milliseconds – less than half a heartbeat and can also image hearts with a fast or irregular beat without the need for beta blockers.

MDS Analytical Technologies makes available a new method for melanin detection in food

Jim Marino — Mon, 17 Nov 2008 13:14:18 +0000

MDS Analytical Technologies has announced that the Abraxis Melamine Detection Kit has been validated for use on company’s SpectraMax(R) absorbance microplate readers with SoftMax(R) Pro 5 GxP analytical software. The product offers a cost-effective, high-throughput, quality-assurance solution to detect melamine contamination in such food products as milk, infant formula, pet food, and confectionery. This solution further enables the company to expand its offering in applied markets. MDS Analytical Technologies also offers a mass spectrometry-based solution for food safety testing.

Biohit releases two new quick tests

Jim Marino — Thu, 06 Nov 2008 14:52:57 +0000

Biohit has expanded its collection of diagnostic tests for gastro-intestinal diseases by launching its ColonView Hb and Hb/Hp quick tests. Developed for a faster detection and prevention of colorectal cancer, the ColonView quick tests are a simple and cost-effective solution. The testing will facilitate the diagnosis of patients with fecal occult blood (a major marker for colorectal cancer and pre-cancerous large adenomas). Also, the tests will help in identification of other diseases associated with bleeding.

MHRA renews Zila’s OraTest®’s marketing authorization

Jim Marino — Wed, 29 Oct 2008 14:32:01 +0000

The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has renewed the marketing authorization for Zila, Inc.’s OraTest® for an indefinite period. This allows the company to sell its proprietary diagnostic kit for oral cancer in seven European countries with a combined population of 100 million. OraTest is indicated as an add-on to visual examination for patients having high risk of high-grade malignant lesions. It can also be used to screen patients who have received treatment for oral squamous cell carcinoma. The kit has pharmaceutical grade tolonium chloride rinse product which is patented with Zila.