According to the Centre for Disease Control and Prevention, CDC report 2017; 30.3 million Americans – 9.4 percent of the U.S. population had diabetes in 2015. Home blood glucose monitoring is useful to determine the daily adjustments in treatment or insulin intake. It is advised to follow doctor's recommendations about how often to test the glucose levels.

According to an article published in JAMA Intern. Med., 2018, one may not need to test themselves several times a day if it is stable type 2 diabetes and on agents (drugs) that do not cause hypoglycemia. According to this article, about 23% filled 3 or more claims for test strips during the year, 14.0% of the study population were using the supplies inappropriately; about 8.8% of subjects were taking agents, which are not considered to be a risk for causing hypoglycemia(e.g. metformin hydrochloride) and 5.1% did not have claims for any antidiabetic medications. These two groups used a median of 2.0 strips per day. The median claims cost for test strips was $325.54 per person per year. The low-value care worsens patient-centered outcomes and imparts a negative economic effect. Thus, one should avoid routine multiple daily self-glucose monitoring in adults with stable type 2 diabetes or on agents that do not cause hypoglycemia.

Blood glucose monitoring measures glucose levels at the time of testing. However, blood glucose levels do fluctuate according to food intake and physical activity. Currently, to monitor diabetes, glycated hemoglobin (HbA1c) is considered as a standard which assesses long-term average blood glucose for a period of last three to four months. It is reported that HbA1c is not effective in clinical situations which may interfere with the metabolism of hemoglobin, such as in hemolytic or iron deficiency anemia, hemoglobinopathies, iron related complications in pregnancy, and uremia.

As an alternative to blood glucose testing, a short 30 day monitoring of glycated albumin should be examined. Albumin is the largest circulating protein in the blood. Glycated albumin refers to albumin attached to glucose and offers an advantage of monitoring average blood glucose over a short-term period of one month (as albumin replaces itself every 30-days). A rapid test for GA could be a significant benefit for patients to control diabetes and other related complications on a monthly basis. Epinex has patented a rapid test for Glycated Albumin (G1A) and is developing this test for clinical trials. G1A tests measures total albumin and glycated albumin exclusively, in a handheld device as a POCT (Point of Care Test) for doctors’ offices and clinics, and as an OTC (Over The Counter) test for general public use.

Reference: Kevin D. Platt, Amy N. Thompson, Paul Lin, MS., et al. Assessment of self-monitoring of blood glucose in individuals with Type 2 diabetes not using insulin. JAMA Intern Med. 2018. doi:10.1001/jamainternmed.2018.5700

Bhairavi Vajaria, Ph.D.

Research and Development Associate

Epinex Diagnostics, Inc.

Asad Zaidi, founder and CEO of Epinex Diagnostics Inc., presented at the Plug and Play Tech Center for the event called Health Tech Friday Pitch Day. Plug and Play is the ultimate innovation platform with over 50 industry-themed accelerator programs, 250 leading corporations, and 260 world’s best VCs. With successful startup million dollar companies such as Paypal and Dropbox, this is the greatest incubator for startups to become world leading corporations. Asad mentioned that “it was an exhilarating experience to see the startup ecosystem in the Silicon Valley” and he feels grateful for the opportunity to connect with other like-minded entrepreneurs to discuss novel health innovations and digital technology. #PlugandPlay #EpinexDiagnostics #SiliconValley #healthandtechnology

The 2018 LIGHT Forum, Leaders in Global Healthcare and Technology, is happening on May 8-9th at Stanford University, in attendance will be over 250 top leading executives throughout the nation. Luminaries such as Ambassador Susan E. Rice, former US National Security Adviser, and Senator George Mitchell, Chairman of DLA Piper, now Chairman Emeritus, will be present on the first day to participate in the keynote conversation: A Chinese Century or American Revival. Peter Orszag, Vice Chairman of Investment Banking at Lazard, DJ Patil, former U.S. Chief Data Scientist, will discuss Artificial Intelligence to define the healthcare industry. Among other's will be Omar Ishrak CEO of Medtronic, and Oliver Bramdicourt,

Stress hyperglycemia, or “stress diabetes,” is a condition that causes temporarily elevated blood glucose during recovery after a heart attack or stroke, even for non-diabetic patients.

The American Heart Association recently posted an article entitled, “Another risk identified from ‘stress diabetes’ – and a possible new way to measure it”. It is based on a recent article published in the journal ‘Stroke AHA,’ reporting on a study conducted on 3026 patients. In these patients, stress hyperglycemia was measured by evaluating a ratio of fasting glucose and glycated albumin (GA). A total of 299 (9.9%) subjects had a new stroke within 3 months. The study found that this increased risk of stroke was associated with a higher glucose/GA ratio. In addition stroke patients who were severely hyperglycemic were 1.5 times more likely to have a secondary stroke than those with minor or no hyperglycemia.

This research shows that a higher ratio of fasting glucose to GA was associated with elevated risk of stroke in patients with a minor ischemic stroke or transient ischemic attack (temporary blockage of blood flow to the brain). The article demonstrates a new potential for glycated albumin to be used for monitoring risk of secondary stroke and stress diabetes as well as in monitoring diabetes.

Epinex has been at the forefront in advocating a role for Glycated Albumin for early detection, screening and monthly monitoring of diabetes. Epinex has a patented rapid test, G1A, for Glycated Albumin and is working towards developing this test for clinical trials. This G1A tests measures total albumin and glycated albumin exclusively (not fructosamine), in a hand held device as a POCT (Point of Care Test) for doctors’ offices and clinics, and as an OTC (Over The Counter) test for general public use.

Source:

1. https://news.heart.org/another-risk-identified-stress-diabetes-possible-new-way-measure/ Another risk identified from ‘stress diabetes’ — and a possible new way to measure it. By AMERICAN HEART ASSOCIATION NEWS.

2.Stress Hyperglycemia and Prognosis of Minor Ischemic Stroke and Transient Ischemic Attack. The CHANCE Study (Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events). https://doi.org/10.1161/STROKEAHA.117.019081; Stroke. 2017;STROKEAHA.117.019081

Bhairavi Vajaria Ph.D.

Research and Development Associate

Epinex Diagnostics, Inc.

A recent review article written by Epinex’s staff and published by Springer-Nature Journal “Inflammation Research’ 2017, highlights the utility of GA measurement both as mediator of inflammation as well as a marker to track hyperglycemia and other diabetic complications. This review shows an association of glycated albumin with inflammation and other diabetic complication like atherosclerosis, diabetic retinopathy, nephropathy (CKD) and rheumatoid arthritis.

The review outlined the following specific associations between glycated albumin and inflammatory disease processes:

GA has a role in atherosclerosis. GA causes inflammation of endothelial cells lining the blood vessels, which can lead to development of plaque in arterial walls and further leads to Coronary Artery Disease (CAD).GA is also involved diabetic retionopathy. It causes release of inflammatory molecules like cytokines in retinal cells that lead to diabetic retinopathy.GA causes chronic kidney disease/nephropathy. Increased GA is associated with irregular renal nephrin (nephrin is a protein necessary for the proper functioning of the renal filtration barrier), promoting proteinuria (presence of excess proteins in the urine) and glomeruloscelrosis (hardening of the glomerulus in the kidney) and eventually nephropathy (thickening of glomerular basement membrane) / chronic kidney disease (CKD).GA is also involved in rheumatoid arthritis (inflammation of joints) and studies have shown that GA was able to predict the progress of rheumatoid factor +RA.

A rapid test for GA could be a significant benefit for patients to monitor inflammation and other related complications on a monthly basis. Epinex has patented a rapid test for Glycated Albumin (G1A) and is developing this test for clinical trials. G1A tests measures total albumin and glycated albumin exclusively (not fructosamine), in a hand held device as a POCT (Point of Care Test) for doctors’ offices and clinics, and as an OTC (Over The Counter) test for general public use.

Source: Glycated albumin (GA) and inflammation: role of GA as a potential marker of inflammation. Roohk, H.V., Zaidi, A.R., Patel, D. Inflamm. Res. (2017).

Full Article: https://doi.org/10.1007/s00011-017-1089-4

Bhairavi Vajaria Ph.D.

Research and Development Associate

Epinex Diagnostics, Inc.

Cardiovascular autonomic neuropathy (CAN) is one of the most overlooked of the serious complications of diabetes. CAN causes damage to the autonomic nerve fibers that excites the heart and blood vessels, resulting in abnormalities in heart rate control and vascular dynamics.A recent article shows an association of glycated albumin and CAN development in type 2 diabetic patients. It investigated the relationship of cardiovascular autonomic neuropathy (CAN) with glycated albumin (GA) and with HbA1c fluctuations in type 2 diabetic patients. The study included 498 type 2 diabetic patients initially without CAN. GA and HbA1c levels were regularly measured over 2 years. 53 subjects (10.6%) developed CAN over the 2-year period. Results of the study indicated that GA and HbA1c levels were significantly higher in subjects with CAN. Moreover, higher serum GA rather than HbA1c was more significantly associated with CAN. Also the predictive power of GA is increased when combined with HbA1c.The study thus demonstrates a new potential for GA as an indicator of CAN in type 2 diabetic patients in addition to the established role of GA in monitoring diabetic complications.

Epinex has been at the forefront in advocating a role for Glycated Albumin for early detection, screening and monthly monitoring of diabetes. Epinex has a patented rapid test, G1A, for Glycated Albumin and is working towards developing this test for clinical trials. This G1A tests measures total albumin and glycated albumin exclusively (not fructosamine), in a hand held device as a POCT (Point of Care Test) for doctors’ offices and clinics, and as an OTC (Over The Counter) test for general public use.

Source: Cardiovascular Diabetology 2017; 16:127

https://doi.org/10.1186/s12933-017-0619-2

https://cardiab.biomedcentral.com/track/pdf/10.1186/s12933-017-0619-2?site=cardiab.biomedcentral.com

Image source: http://care.diabetesjournals.org/content/33/2/434

Bhairavi Vajaria Ph.D.

Research and Development Associate

Epinex Diagnostics, Inc.

Figure 1 A Review of Glycated Albumin appears first on Google search and has reached 100 citations

Epinex Diagnostics, Inc. reaches a new milestone after having its research paper “A Review of Glycated Albumin as an Intermediate Glycation Index for Controlling Diabetes” reach 100 citations by other leading scientific papers. This article was written by Epinex’s Scientific Advisory Board member, Dr. H. Vernon Roohk with the help of other Scientific Advisory Board members, Communications Director, Dr. David Trasoff and Asad R. Zaidi, CEO of Epinex. At the time of this writing, this article appears as the first link in a Google search for ‘glycated albumin’. Epinex’s website also appears on the first page.

Epinex has been at the forefront in advocating a role for Glycated Albumin for early detection, screening and monthly monitoring of diabetes. Epinex has patented a rapid test -G1A- for Glycated Albumin and is developing the test for clinical trials. G1A measures total albumin and glycated albumin exclusively (not fructosamine) in a hand held device as POCT (Point of Care Test) for doctors’ offices, clinics and as an OTC (Over the Counter) test for general public use.

For further information about Epinex please see:

Review of Glycated Albumin Paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769832/

Epinex attended the 69th AACC Annual Scientific Meeting & Clinical Lab Expo, which took place July 30 through August 3 2017 at the San Diego convention center. One of the highlights of this expo was the “Beyond Hemoglobin A1c” symposium that took place in the afternoon of August 1. Close to 200 attendees were at this symposium, where three speakers; David Sacks, Cyrus Desouza, and Paul J. Thornalley, discussed the challenges associated with Hemoglobin A1c (HbA1c) and explored alternatives such as Glycated Albumin (GA) and Fructosamine.

During his presentation, David Sacks stated that HbA1c was well standardized and the most widely used marker of chronic glycemia. Sacks explained how Fructosamine and GA reflect extracellular protein glycation independent of Red Blood Cells (RBCs). Of these two alternative markers, Sacks talked about how there are efforts being made to standardize GA. He mentioned that there is an entire committee in Japan working to standardize GA. The paper on glycated albumin published by this committee has cited the article written by Epinex Scientific Advisory Board member Dr. Vern Roohk.

Cyrus Desouza highlighted the clinical utility of GA with five main points. The first is that GA can be an intermediate glycemic control marker. The second is that GA can be used for Chronic Kidney Disease (CKD). Third, it can be used during pregnancy for gestational diabetes mellitus (GDM) and diabetes mellitus (DM). Fourth, it can be used for insulin titration and medication changes. Lastly, it can be used for any condition that shortens erythrocyte survival (i.e. anemia and hemoglobinopathy).

Some of the key takeaways from Desouza’s presentation include how GA is better at detecting variability, hyperglycemia and short-term fluctuations as compared to A1c. Another main point was that when GA is expressed as a ratio of albumin concentration, it’s more reliable and cost effective compared to A1c. He also said that GA is a good indicator for detecting the future risk of developing diabetes complications and that that it is clinically useful in titrating insulin, during pregnancy and in the setting of Chronic Kidney Disorder (CKD).

The last speaker, Paul J. Thornalley focused his presentation on the role of advanced glycation end products (AGEs) in diabetes.

Epinex has been at the forefront in advocating a role for Glycated Albumin for early detection, screening and monthly monitoring of diabetes. Epinex has a patented rapid test, G1A, for Glycated Albumin and is working towards developing this test for clinical trials. This G1A tests measures total albumin and glycated albumin exclusively (not fructosamine), similar to what Desouza described, in a hand held device as a POCT (Point of Care Test for doctors’ offices and clinics and as an OTC (Over The Counter) test for general public use.

For further information about Epinex please see www.epinex.com

The American Association for Clinical Chemistry (AACC) and the American Diabetes Association (ADA) have recognized the need to look beyond HbA1c for biomarkers in diabetes management. They have joined forces and holding a symposium during the 69th AACC Annual Scientific Meeting & Clinical Lab Expo taking place in San Diego July 30-August 3 2017. Symposium will explore supplemental biomarkers “Looking Beyond HbA1c ”. it will be held during AACC meeting on August 1, 2017 at 2:30pm.

Epinex has been at the forefront in advocating a role for Glycated Albumin for early detection, screening and monthly monitoring of diabetes, we are very excited to attend this particular symposium. Epinex had patented a rapid test -G1A- for Glycated Albumin and is developing the test for clinical trials. G1A measures total albumin and glycated albumin exclusively (not fructosamine) in a hand held device as POCT (Point of Care Test)for doctors’ offices and clinics and as a OTC ( Over The Counter) test for general public use.

Please see the links below.

https://www.aacc.org/publications/cln/cln-stat/2017/july/25/looking-beyond-hba1c

www.epinex.com

Diabetes is rampant in the United States and places an increasing burden on the U.S. healthcare system. In California, 9 percent of adults suffer from diabetes and more than half of the state’s population is considered prediabetic. Within the next five years, almost 70 percent of the prediabetes population is predicted to become diabetic. These are frightening numbers and California has recognized the severity of this epidemic at a time when U.S. lawmakers are debating whether to repeal and/or replace the ACA (Affordable Care Act). California, where the ACA is highly popular and has widespread support, continues to buck the national trend. State officials recently passed a bill that will enroll Medi-Cal recipients in a diabetes prevention program. These programs, starting in July of 2018, will encourage patients with prediabetes to exercise, eat healthy, and reduce stress, with a goal of helping them to lose between 5 to 7 percent of their body weight.

Investing in the prevention of diabetes will help the state reduce the growth of diabetes in California. The additional Medi-Cal costs resulting from the much more expensive care required for the treatment of diabetes complications will be greatly reduced. Projected savings are estimated to be over $45 million a year.

Epinex Diagnostics, Inc., a privately held biomedical company located in Tustin, California, shares this goal by focusing on point-of-care tests that address diabetes control. It is developing a monthly G1A test for glycated albumin, which can bridge the gap between daily glucose monitoring and long-term HbA1c testing every 4 to 6 months. Epinex believes that the G1A test can play a significant role in the early diagnosis and prevention of diabetes.

Reference- http://www.latimes.com/local/california/la-me-ln-diabetes-prevention-20170711-story.html

Saturday June 10 2017, Epinex’s scientific advisory board member, Alan Carter presented at the American Diabetes Association’s (ADA) 77th scientific session. Alan Carter presented during the ADA symposium session "Dealing with the Rising Costs of Insulin-An Active Dialogue". His portion was titled "Understanding the Players in the Rising Costs of Insulin".

Alan Carter currently is a contracted Principal Investigator (PI) for NIH-NINDS Drug Manufacturing and Formulation and the NIH-NCATS Drug Substance Development and Manufacture programs.

He has over 20 years of experience directing multi-state business operations for a chain of community pharmacies, clinical pharmacy practice, and hospital pharmacy practice.

Dr. Carter has been responsible for multisite management of clinical trials for the evaluation and design of biologic metabolic markers and medical devices. He has provided disease management/formulary consulting for employers, health care plans, and biotech companies. Dr. Carter's expertise has been used by companies such as Argus Health Systems, Children's Mercy Family Health Partners, Johnson & Johnson Lifescan Division, LXN, Lockheed Martin Aerospace, and the US Army Research Institute of Environmental Medicine.

Alan Carter Presenting at the American Diabetes Association’s (ADA) 77th scientific session

Also in attendance, was Epinex CEO, Asad Zaidi

Epinex Scientific Advisory Board: Dr. David Horwitz (Left) and Alan Carter, PharmD (Right)

A recent journal article published in Clinical Chemistry investigated whether glycated albumin (GA) could be an alternate glycemic control indicator where hemoglobin A1c (HbA1c) is not a reliable indicator. The article concluded that the increased mortality in type 2 diabetes patients on hemodialysis is associated with high GA measurements. GA was measured at three different time points in 1255 type 2 diabetes patients on hemodialysis.

Source: http://clinchem.aaccjnls.org/content/63/2/477

Contact: Kajal Bains Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

A recent review article in Critical Reviews in Clinical Laboratory Sciences analyzes glycemic control indicators such as hemoglobin A1c (HbA1c), glycated albumin (GA), and GA/HbA1c ratio. This article concludes that it is important to be able to select an appropriate glycated protein depending on each patient’s health status. Reports indicate that HbA1c is not always a suitable glycemic indicator even though it “is one of the most important diagnostic factors for diabetes” Consequently, proteins such as GA that are not limited by the influence of changes in the lifespan of erythrocytes may be able to bridge the gap in diabetes diagnostics.

Reference: http://www.tandfonline.com/doi/full/10.1080/10408363.2017.1299684?needAccess=true

Contact: Kajal Bains Corporate Communications Associate Epinex Diagnostics, Inc. kajal@epinex.com

The Journal of the American Medical Association recently published an article that analyzed the effectiveness of hemoglobin A1c (HbA1c) as a measure of diabetes outcomes. Lead researchers Dr. Kasia Lipska, MD and Dr. Harlan Krumholz, MD concluded that “treatment should be selected to target specific complications and inherent risks, not solely glucose levels.” Therefore, the authors suggest an alternative view that recommends identifying drugs for diabetes care based on outcomes such as reduction in heart disease or mortality.

Three clinical trials investigating glycemic control during the use of cardioprotective therapies showed “that lowering HbA1c levels to less than 7% of total hemoglobin was not associated with cardiovascular benefits compared with less intensive glycemic control.” Several other trials also demonstrated that small change in glycemic control levels did not affect outcome significantly. This study suggests that “trials that use outcomes based solely on glycemic parameters are no longer acceptable for clinical decision making, [and] investments in pragmatic studies of existing agents are needed to understand the impact on outcomes of all treatment options.”

Epinex believes that glycated albumin should be evaluated as an alternative measurement tool in addition to such current methods and existing agents.

Source: http://jamanetwork.com/journals/jama/fullarticle/2599765

Contact: Kajal Bains Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

TUSTIN, Calif. - Feb. 8, 2017 - PRLog -- Epinex Diagnostics, Inc., a private medical company that focuses on point-of-care diagnostic tests, announced today that Asad Zaidi, CEO and James McCarthy, Senior Vice President will present at the 19th annual BIO CEO & Investor Conference in New York, NY on Feb. 13, 2017 at 8:00 a.m. ET in the Conrad Room at the Waldorf Astoria New York. The company has developed three patented innovative point-of-care products; beyond proof of concept, ready to be manufactured and deployed in the market. The Epinex G1A test for glycated albumin will be used for diabetes monitoring, screening, and diagnostics. It addresses the gap between daily blood sugar testing and HbA1c testing. The Epinex ACR test is an early indicator of renal (kidney) failure that uses a portable, handheld reader device. The Epinex SimplySure PT/INR test is a non-electronic microfluidic PT-INR test that was developed as an alternate to current PT-INR tests that require an external digital device. About Epinex Diagnostics, Inc. Epinex Diagnostics, Inc., a private medical company that develops innovative point-of-care diagnostic tests, strives to be at the forefront of new, cutting edge technology. They will be available to meet or set up meetings after the conference. Contact Epinex Diagnostics, Inc. 14351 Myford Road Unit J Tustin, CA 92780 +1 (949) 660-7770 www.epinex.com

Clinical Chemistry and Laboratory Medicine (CCLM) recently published an analysis of hemoglobin A1c (HbA1c) and glycated albumin (GA) as effective glycemic markers. This study, led by Dr. Roberto Testa, MD of INRCA-IRCCS National Institute concluded that GA% (GA on total albumin ratio) is a useful indicator for diabetes management and monitoring where HbA1c is limited.

As summarized in the article, several past studies support the potential for GA to be an overall marker for diabetes. For example, GA% is found to be useful when “HbA1c loses reliability…in anemic, hemoglobinopathic, and kidney disease” patients and “as a diabetes screening index in blood donors.” Moreover, a Chinese study revealed that combining GA with fasting plasma glucose (FPG) “increases diabetes detection and reduce[s] resorting to the oral glucose tolerance test (OGTT).”

Another study that assayed GA% on three analytical platforms conducted at San Raffaele Hospital laboratory found a good correlation of GA% vs. HbA1c. This report concludes that the high correlation found between GA% and HbA1c clearly confirms that glycated albumin is as good an indicator of protein glycation as HbA1c and that GA% is directly dependent on protein exposure to glucose.”

The article also recommends further investigation of GA's “usefulness in diabetes diagnosis or diabetic patient follow-up” because of its unique capability “to assess glycation exposure in a shorter time frame.” This supports the FDA’s recent efforts to highlight diabetes outcome measures beyond HbA1c including a public workshop this past August to fuel a discussion about novel therapies for patients with diabetes. According to the article, further research in “different scenarios can confirm the value of GA% as a stand-alone test or in combination with FPG and HBA1c as an added information in patient screening or staging.”

Source: https://www.degruyter.com/view/j/cclm.2017.55.issue-2/cclm-2016-0512/cclm-2016-0512.xml

Contact:

Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

"America’s sweet tooth is huge, and it’s satisfied by both sugar and, increasingly, low-calorie sweeteners, according to research out this month."

Source- http://www.forbes.com/sites/ritarubin/2017/01/30/whether-replacing-sugar-with-low-calorie-sweeteners-is-a-smart-health-move-remains-to-be-seen/#73914c2d6079

"According to the International Diabetes Federation diabetics run the risk of developing serious health problems affecting the nerves, eyes, kidneys, heart and blood vessels. They also have a higher risk of developing infections."

Source- http://www.health24.com/Lifestyle/Healthy-Nerves/how-diabetes-can-affect-your-nerves-20170116

Global research and consulting organization Frost and Sullivan has just published an article written by Epinex in the January 2017 edition of their eBulletin. The article is titled “Leveraging New Technologies for Better Diabetes Care.”

Published in Medical Technologies eBulletin (Frost & Sullivan)

January 2017 | Vol. 10 | Issue 1

A recently published review article in Diabetes Care investigated various glycated proteins that can be used for diabetes diagnosis and management. The study concluded that fructosamine, glycated albumin, and advanced end products (AGEs) can be used for assessment and treatment where traditional HbA1c testing is limited. The authors predict that the “newer measures of glycated proteins will [not] be studied” as thoroughly as HbA1c “because of limited funding.” The article proposes development of “innovative strategies to establish the evidence base for the link between other glycated proteins and clinical outcomes, so that treatment targets or diagnostic thresholds can be developed.”

Source: http://care.diabetesjournals.org/content/39/8/1299

Contact:

Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

November is recognized as American Diabetes Month as part of a national effort to raise awareness of the disease. This is an important month to recognize and support the millions of people who are diagnosed with diabetes. Epinex Diagnostics, Inc. is proud to spread diabetes awareness and support the diabetes community through our social media and blogging efforts. Epinex has also just launched the “Am I Diabetic” app in order to commemorate this month.

The Centers for Disease Control (CDC) report that approximately 29.1 million people in the United States have diabetes and approximately 86 million have prediabetes. It is important to keep the public informed and educated about this disease as the number of diagnoses continues to rise.

Source: https://www.cdc.gov/diabetes/pubs/statsreport14/national-diabetes-report-web.pdf

Download Am I Diabetic App

Contact:

Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc. kajal@epinex.com

Tustin, CA, November 17, 2016 – Epinex Diagnostics, Inc., a Tustin, California USA based biomedical company, commemorates National Diabetes Month by launching the “Am I Diabetic” mobile phone app for iPhone and Android devices. The function of this app is to provide educational information and awareness about diabetes. With over half a billion people around the world suffering from diabetes and millions more at risk, digital health platforms such as Am I Diabetic have the potential to provide unprecedented access to diabetes education.

This informational app features a BMI calculator and a diabetes risk test. The BMI (Basal Metabolic Index) is a crucial measure of obesity and an elevated BMI is a major indicator of type 2 diabetes risk. The diabetes risk test evaluates the user’s likelihood to develop diabetes. The app also provides users with easy access to stress relieving exercises like yoga and meditation. In addition, this app comes with links to diabetes-friendly recipes, books, events and news as well as a map of diabetes prevalence around the world. These resources will allow users to conveniently learn about the disease and will help them to take preventive measures.

Epinex plans to expand its use of the mobile digital health platform with its upcoming “MyG1A” app. This app will interface with the Epinex G1A Rapid Test for diabetes monitoring, which measures glycated albumin in a hand held device. This test is in the development phase and is intended to become a monthly point of care test for diabetes screening and management. Over a decade of research has shown that glycated albumin can be used as an effective monthly marker for diabetes management. Because albumin naturally replaces itself every 30 days, true diabetic status is reflected in an accurate measurement of the damage to albumin caused by diabetes.

About Epinex Diagnostics, Inc.

Epinex Diagnostics is a private medical company that develops innovative point-of-care diagnostic tests and strives to be at the forefront of new, cutting edge technology. Follow the company on Twitter and Facebook for the latest developments, watch the App Video and visit www.epinex.com for more information.

Download Am I Diabetic App

Contact:

Kajal Bains

Corporate Communications Epinex Diagnostics, Inc.

Phone: 949-660-7770, ext. 107

kajal@epinex.com

Type 2 diabetes causes an inflammatory response (swelling of the body) that increases the risk of stroke, heart attacks, and other complications. Researchers at Washington University School of Medicine recently investigated the mechanism behind inflammation. The study concluded that “by blocking the production of fat inside [immune] cells, it may be possible to prevent inflammation in people with diabetes and… other conditions, such as arthritis and cancer.” Lead scientist Clay F. Semenkovich’s team “genetically altered mice that could not make the enzyme for FAS” and found “that the mice were protected from diet-induced diabetes.” Researchers are now exploring both existing drugs and other developing methods that can block chronic inflammation but still allow macrophages to fight infection.

Source: https://www.sciencedaily.com/releases/2016/11/161102080309.htm

Contact: Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

A recent article in Endocrinology and Metabolism investigated whether hemoglobin A1c and glycated albumin are effective indicators of prediabetes in obese and nonobese African immigrants. Oral glucose tolerance tests (OGTTs) were administered to “236 self-identified healthy African immigrants” in order to screen for prediabetes. The study concluded that “glycated albumin contributes by identifying prediabetes not detected by HbA1c in nonobese African immigrants.” Further studies hope to analyze a larger cohort of immigrants in order to strengthen the results.

Source: https://www.ncbi.nlm.nih.gov/pubmed/27624138

Contact: Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

Public Health England recently published an analysis of the predicted number of people who could develop diabetes in the near future. The organization concluded “that one in 10 adults in the UK will be at risk of developing diabetes by 2035” and that “the number of people with the disease could top five million if obesity rates continue to increase.” 90 percent of the diabetic population was found to be type 2 diabetic. The study also revealed that if current obesity rates in the UK remain constant, the increase in type 2 diabetes by 2035 could be even greater. If this occurs, the National Health Service (NHS) of England could go bankrupt.

Source: http://www.bbc.com/news/health-37720610

Contact: Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

Dr. Yehuda Handelsman of the Metabolic Institute of America recently discussed the limitations of HbA1c as a glycemic indicator. He concluded that HbA1c “is not the most accurate measure for patients with severe kidney disease, sickle cell anemia, [and] various blood diseases.” Although continuous glucose monitoring (CGM) is also a suggested measure of diabetes outcomes, Dr. Handelsman points out that CGM is not available for many type 2 diabetics. Therefore, he proposed measuring fructosamine, glycated albumin, or advanced glycation end-products (AGEs) to better monitor type 2 diabetes.

Source: http://www.healio.com/endocrinology/diabetes/news/print/endocrine-today/%7B03a80900-36d7-48a7-8805-3b4734e25844%7D/what-metrics-should-be-considered-beyond-hba1c-to-best-measure-diabetes-outcomes Contact: Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

Public Health England recently published an analysis of the predicted number of people who could develop diabetes in the near future. The organization concluded “that one in 10 adults in the UK will be at risk of developing diabetes by 2035” and that “the number of people with the disease could top five million if obesity rates continue to increase.” 90 percent of the diabetic population was found to be type 2 diabetic. The study also revealed that if current obesity rates in the UK remain constant, the increase in type 2 diabetes by 2035 could be even greater. If this occurs, the National Health Service (NHS) of England could go bankrupt.

Source: http://www.bbc.com/news/health-37720610

Contact: Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

San Francsico-based digital health company Omada Health has initiated a program to help prevent type 2 diabetes in low-income communities by improving how people eat and exercise. The company already provides an online program to help people with pre diabetes, but is now trying to spark lifestyle changes through a similar program designed specifically for people with pre diabetes in underserved communities.

Since people in these communities cannot always afford year-round medical services, Omada hopes to implement technology they already use to help them regularly monitor their health. The challenge, however, is that people may not place importance on healthcare when they are facing several other challenges. Public health expert Michael Cousineau states, “These are very poor people, so there are a lot of things on their plate, if you will. So if they can move things off the top of their agenda to make this successful, that’s the question.”

Source: https://www.statnews.com/2016/07/29/diabetes-digital-health-medicaid/

Contact:

Kajal Bains Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

Nonalcoholic fatty liver disease (NAFLD) has become the most common type of chronic liver disease in children. It causes liver inflammation and damage, and there are more than 3 million cases of it in the US alone. Although various diseases are linked to NAFLD, the exact underlying mechanism has not been found. According to a recent study, type 2 diabetes and prediabetes are common in children with NAFLD. Research on children with NAFLD from clinical centers of the National Institute of Diabetes and Digestive and Kidney Diseases NASH Clinical Research Network indicates that the prevalence of prediabetes is 23.4 percent and of type 2 diabetes is 6.5 percent.

Lead author, Dr. Jeffrey B. Schwimmer states, “based on our data, we conclude that NAFLD is one of the biggest risk factors for the development of type 2 diabetes in children.” This study also reveals that compared to people with normal blood sugar levels, prediabetics are more likely to have severe liver inflammation and damage or type 2 diabetes. Therefore, careful monitoring and prevention of type 2 diabetes could potentially decrease the incidence of NAFLD.

Source- http://www.healio.com/hepatology/steatohepatitis-metabolic-liver-disease/news/online/%7B2555fbfe-8f6a-47c0-b4b8-7312a299a829%7D/type-2-diabetes-prediabetes-common-in-children-with-nafld

The standard protocol for diabetes monitoring and management has been a combination of multiple daily blood sugar testing and twice a year HbA1c testing. Blood sugar testing is painful and expensive, and demands a high level of compliance to be useful. The required interval between HbA1c tests means that people with diabetes have to wait an entire six months before they can get an updated analysis of their condition.

The crucial need to develop alternate diabetes monitoring systems has now been recognized by the highest level of the scientific and medical communities. The FDA has scheduled a public workshop to give patients and industry leaders a chance to discuss the future of diabetes management. It is geared specifically towards discussing diabetes outcome measures beyond HbA1c with the aim supporting the development of “novel therapies that directly address the needs” of diabetics.

The workshop was organized in partnership with The diaTribe Foundation, JDRF, the American Diabetes Association, the American Association of Clinical Endocrinologists, and Anna McCollister-Slipp/Scripps. HCM Strategists and The diaTribe Foundation are inviting public participation by asking for submission of video clips and written comments in order to bring as many public voices to the event as possible.

The Epinex Diagnostics team is excited to have the opportunity to participate in this FDA workshop and bring our G1A test to the attention of the participants. Over a decade of scientific research has established that the use of glycated albumin (GA) as a monthly marker for diabetes management is a more effective test to monitor diabetes than HbA1c. We believe that the Epinex G1A monthly point-of-care rapid test for glycated albumin has the potential to revolutionize diabetes monitoring.

Article Source: http://www.fda.gov/Drugs/NewsEvents/ucm499281.htm

A recent report suggests that the current figure for the number of people with diabetes worldwide is significantly underestimated. Professor Paul Zimmet of Monash Unversity, publishing in Nature Reviews, believes that the correct figure is 520 million, considerably more than the International Diabetes Federation (IDF) figure of 415 million.

Professor Zimmet states that the current global diabetes data is sub-par and that there remains an inconsistency in how this data is gathered. He reports that since “fasting blood sugar has been used as the diagnostic test for…the Australian 2012-2013 National Health Survey, it is almost certain [that] the true burden of disease has been underestimated.” Why does using fasting blood sugar as a test lead to an underestimate? Although the paper suggests that a lack of data on diabetes in many countries contributes to this underestimate, it also highlights the need for a new blood glucose test for both fasting and non-fasting time points. We need a better alternative to self-monitoring blood glucose testing in order to improve patient wellbeing and research.

Article Source: https://www.sciencedaily.com/releases/2016/07/160711121513.htm

"Growing up, Anthony and Ian Whitington’s father, Geoff, was an energetic and committed dad. Having divorced from the boys’ mother when they were 10 and eight respectively, Geoff, then a BT engineer, gave up his weekends to allow the boys to do whatever they fancied – be it sports or day trips."

Source- http://www.telegraph.co.uk/men/health/meet-the-brothers-who-reversed-their-fathers-diabetes/

Several women around the globe are affected by gestational diabetes year after year. Gestational diabetes is a form of high blood sugar that targets pregnant women during their pregnancy and causes some to develop Type 2 diabetes in the years after. Studies have revealed that women who breastfeed have a 40 Percent lower risk of developing Type 2 diabetes following their pregnancy.

Although the mechanism behind this phenomenon is not yet understood, scientists are exploring whether metabolism could be playing a role. In order to do this, the blood samples of more than 200 patients with gestational diabetes were analyzed in comparison to 156 metabolites. Dr. Much reports “the metabolites in women who had breastfed for more than three months differed significantly from those who had shorter lactation periods.” As this research progresses, the scientific community will look to translate these findings into effective treatments.

Article Source: http://thediabeticnews.com/breastfeeding-protects-against-diabetes-alters-maternal-metabolism/

Contact: Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

As medicine and technology advance more and more with each coming year, new strains of vaccines are invented in order to protect against various diseases. The flu vaccine has been available to the public since the 1900s, but new advancements in its potential benefits are still being discovered.

The Imperial College London recently published a study done on 124, 503 UK adults who had Type 2 diabetes. When compared to those who were not vaccinated, the vaccinated individuals had a reduced percentage of hospital admissions for stroke, heart failure, and pneumonia or influenza. The death rate of vaccinated diabetics was also 24 percent lower than diabetics who were not vaccinated. Even so, around one third of the English, diabetic population does not get vaccinated every year. Therefore, it is important that further research be done on this topic to expand the preliminary results.

Article Source: http://www.eurekalert.org/pub_releases/2016-07/icl-fvm072216.php

Contact: Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

In the United States alone, an estimated 29 million people have diabetes and an additional 86 million are pre-diabetic. Diabetes is the “seventh leading cause of death,” and diabetics have an alarming 56 percent more likelihood of dying from a “classic” heart attack than non-diabetics. Undoubtedly, the focus on preventive measures is key right now.

Dr. Nina Radcliff, a physician anesthesiologist, explains that we can protect ourselves from the harmful complications of diabetes by making smart, healthy choices in our every day lives. Engaging in regular, moderate physical activity, maintaining a healthy weight, and increasing fiber consumption are all ways in which we can make sure our blood glucose and insulin sensitivity levels are well regulated.

Article Source: http://www.pressofatlanticcity.com/life/taking-action-prevention-important-in-face-of-diabetes/article_c3352460-505e-11e6-bfe6-3782ce73d70c.html

Contact: Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

When thinking about diabetes, certain complications such as cardiovascular disease and eye damage are quick to come to mind. Mental health issues such as depression and anxiety, however, are not as easily related to diabetes.

Recent studies done on patients with eye conditions caused by diabetes reveal that there are psychological implications associated with diabetes complications as well. Not only did 15 percent of these participants with eye damage test positive for depressive symptoms, but also 23% tested positive for anxiety symptoms. There was also an independent association found between severe diabetic retinopathy, commonly referred to as diabetic eye disease, and greater depressive symptoms. These studies are still not advanced enough to establish a strong association but highlight the need for further research in the relationship between diabetes and mental health.

Article Source: http://thediabeticnews.com/diabetic-retinopathy-linked-to-higher-depression-risk/

Contact: Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

If you own a smartphone and have regular access to wifi, chances are you’ve downloaded Pokémon Go. In less than a month since its release, this augmented reality game that allows people to capture and battle the beloved creatures has already surpassed Twitter in daily use.

Now, University of Leicester researches believe that the physical activity required of Pokémon Go users has the ability to be “an innovative solution for rising obesity levels.” At the core of this game is the need for players to walk certain distances to find creatures and battle at local gyms. This application of the game is particularly exciting for diabetics and diabetes research alike because obesity is the leading cause of developing Type 2 diabetes.

Article Source: https://www.sciencedaily.com/releases/2016/07/160725090154.htm

Contact: Kajal Bains

Corporate Communications Associate

Epinex Diagnostics, Inc.

kajal@epinex.com

"It’s true. All medications have side effects, and numerous studies have shown that cholesterol-lowering statin drugs are linked to a small increase in the risk of Type 2 diabetes, even as they reduce the risk of heart attacks."

Source- http://well.blogs.nytimes.com/2016/07/22/can-statins-cause-diabetes/?_r=0

"The association between hyperglycemia and inflammation and vascular complications in diabetes is now well established. "

Source- http://care.diabetesjournals.org/content/39/Supplement_2/S244

"Lactation for >3 months in women with gestational diabetes is associated with changes in the metabolomics profile that have been linked to the early pathogenesis of type 2 diabetes."

Source- http://www.ncbi.nlm.nih.gov/pubmed/27423999

"Walking briskly for 11.5 miles a week was the best for improving glucose control in people with pre-diabetes"

Source- http://www.mirror.co.uk/news/uk-news/jogging-isnt-best-way-beat-8450639

"Lower limb vascular complications and foot ulcers significantly predict mortality in patients with diabetes, researchers reported at the American Diabetes Association 76th Scientific Sessions in New Orleans."

Source- http://www.medscape.com/viewarticle/866100?src=wnl_mdplsnews_160715_mscpedit_wir&uac=117162FG&impID=1156666&faf=1

"Ever wandered down the 'health foods' aisle of your local grocery store? If it’s anything like the one near me, it’s full of 'low-fat', carb-heavy snack foods.Here’s the problem: Low-fat diets don’t work."

Source- http://www.sciencealert.com/it-turns-out-fat-isn-t-as-bad-as-we-thought-it-was

"Blood pressure and cholesterol levels are improving among Americans with obesity, but overall blood glucose health is deteriorating, according to research published in the Journal of the American Heart Association."

Source- http://www.medicalnewstoday.com/articles/311645.php

"Today Theresa May becomes the second woman to serve as prime minister of the United Kingdom, but she'll be the first major world leader living with type 1 diabetes."

Source- http://www.medscape.com/viewarticle/866060

"A worldwide study of type 2 diabetes has revealed the most detailed picture yet of the genetic factors that affect the condition."

Source- https://wellcome.ac.uk/news/diabetes-risk-more-complicated-predicted

"Low blood sugar, also known as hypoglycemia, can be quite a dangerous condition. It is common among people who have diabetes and can occur even if you are managing it well."

Source- http://food.ndtv.com/health/9-symptoms-of-low-blood-sugar-you-need-to-pay-attention-to-1430089

"A collaboration between Los Alamos, Yale University, and Worcester Polytechnic Institute published research that sheds light on pathological properties of amyloids identified in type II diabetes."

Source- http://www.lanl.gov/discover/news-stories-archive/2016/July/07.6-role-of-amyloids-type-ii-diabetes.php

"In elderly patients with type 2 diabetes, mild cognitive impairment may be independently associated with increased DPP-IV activities, according to study findings published in Diabetes Care."

Source- http://www.healio.com/endocrinology/diabetes/news/online/%7B0c822d14-07ca-4131-b550-5e07f54a1cdf%7D/dpp-iv-activity-linked-to-mild-cognitive-impairment-in-type-2-diabetes

"For kids, the perfect summer can mean sleeping in, eating whenever hunger strikes, playing outdoors in the sun, swimming and staying up late. But for children with Type 1 diabetes, all of the above, and the general lack of schedule, can wreak havoc with their blood sugar levels."

Source- http://www.news-medical.net/news/20160706/Pediatric-endocrinologist-outlines-top-summertime-tips-for-kids-with-Type-1-diabetes.aspx