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PreDx Test Now Available with Finger Stick Collection Method

Tethys Bioscience has announced that the PreDx test, a multi-biomarker blood test used for the stratification and monitoring of prediabetes patients, can now be performed using capillary blood collected via a simple finger stick procedure.

The PreDx test measures seven biomarkers implicated in the development of type 2 diabetes, and utilizes a proprietary algorithm to generate a “personalized” numerical score that ranks a prediabetic’s 5-year risk of progression to diabetes on a scale of 1 to 10, with a higher score indicating a higher 5-year risk of progression. Baseline scores are used to stratify prediabetes patients into low, moderate or high- risk categories for disease progression, then retesting is used to monitor changes in the patient’s score, which reflect the efficacy of preventive interventions in reducing the patient’s level of risk.

“The ability to process seven assays on a serum separator card with only a few drops of capillary blood, and utilize those results to generate the PreDx score, is truly unprecedented” said Ted Tarasow , PhD, Senior Vice President of Research and Development at Tethys Bioscience. “With this new technology and the ease-of-use it offers, we are expanding access to the PreDx test from the 25% of clinicians with in-office phlebotomy to the 88% of primary care practices that routinely perform finger stick tests.”

Juan Frias , MD, Chief Medical Officer at Tethys notes that the development of a finger stick version of the PreDx test has been a company goal from the outset: “Almost without exception, detection of prediabetes – the dominant precursor to type 2 diabetes – occurs in primary care practice. Because PreDx is a prognostic test that differentiates prediabetes patients according to their 5-year likelihood of developing diabetes and enables clinicians to monitor the impact of preventive intervention, it is a valuable new tool that can make an important difference to primary care clinicians in how they manage their prediabetes patients.. That’s why providing broader access to the test became a top priority. ”

Dr. Frias noted that a key consideration in the development of a finger stick sample collection process for PreDx was ensuring that both collection methods produced equivalent test results. In a presentation at the 22nd Annual Scientific and Clinical Congress of the American Association of Clinical Endocrinologists (AACE) earlier this month, Dr. Tarasow shared the results of method comparison studies between matched sets of venous and finger stick blood samples, which showed that the precision and accuracy of PreDx tests performed with capillary blood is equivalent to that of the PreDx test using venous blood. As with PreDx venous, performance of the PreDx test using capillary blood is also statistically significantly better than fasting glucose alone for predicting the development of type 2 diabetes.

Randy Strahan , CEO and President of Tethys Bioscience, commented, “We are very excited about the introduction of a finger stick method of sample collection for PreDx. It will greatly expand access to the test – not only for a larger number of healthcare practitioners, but also for employers and wellness organizations who are seeking ways to reduce the burden of type 2 diabetes through more effective and cost-efficient prevention programs.”

Source: PR Newswire

Health Diagnostic Laboratory, Inc.’s New Diabetes Prevention & Management Panel Incorporates Discovery from Metabolon Researchers

Health Diagnostic Laboratory, Inc., a CLIA-certified laboratory specializing in advanced cardiovascular and metabolic disease testing and health management, has launched a new blood test for stratifying prediabetic patients based on the Quantose™ insulin resistance markers discovered by Metabolon, Inc.

Insulin resistance is a primary risk factor for type 2 diabetes and cardiovascular complications, and the Quantose biomarkers have been incorporated into HDL, Inc.’s newly launched Diabetes Prevention & Management Panel, or DPMP. Following a soft-launch period of limited release, development, and test marketing, HDL, Inc. has incorporated the Quantose™ metabolites seamlessly into DPMP, a 21-test panel available to physicians nationwide beginning this month. Terms of the deal were not disclosed.

“The ability to more accurately identify patients likely to progress to full-blown type 2 diabetes is a powerful tool to help manage the onset of a leading cause of heart disease,” said Tonya Mallory, HDL, Inc.’s President, CEO and Co-founder. “The Quantose markers help complete Health Diagnostic Laboratory’s DPMP and provide physicians with a more accurate, deeper look at the root causes of prediabetes and diabetes.”

Diabetes affects 25.8 million people in the U.S., or 8.3 percent of the population, according to the American Diabetes Association. Nearly one in three U.S. adults – almost 80 million people – meet the criteria for prediabetes.

The Quantose™ biomarkers are novel metabolites detected in blood that reflect insulin resistance and detect progression to prediabetes and diabetes earlier than traditional glycemic measures such as HbA1c. By considering insulin resistance, metabolites provide clinicians with a useful tool that goes beyond traditional measures to stratify patients based on their risk for developing diabetes. The Quantose™markers are particularly useful in identifying prediabetic patients at the greatest risk of disease progression where drug or other interventional therapy may be appropriate. Such a clinical value is well-aligned with American Diabetes Association guidelines, which recommend physicians consider pharmaceutical intervention in high-risk prediabetic patients.

”We are delighted to have an ideal partner in Health Diagnostic Laboratory to bring American clinicians a new tool for identifying and managing patients at risk for developing diabetes,” said John Ryals, CEO of Metabolon. “Our expertise in biochemical profiling is reflected in the discovery of the Quantose markers and represents the culmination of many years of research by our scientists. Importantly, if physicians are able to detect high-risk prediabetic patients earlier, it may allow them to initiate therapeutic interventions capable of preventing diabetes and related complications. The launch of Health Diagnostic Laboratory’s DPMP using the Quantose markers also represents a significant milestone in Metabolon’s evolution from providing biomarker analysis services to discovering cutting-edge metabolomic-based diagnostic markers.”

Source: PR Newswire

Entelos and ISB Announce Collaborative Gene Expression Breakthrough

Entelos Holding Corp. (“Entelos” or “the Company”), a premier provider of physiologicalsystemmodeling and services, and Seattle-based Institute for System Biology (ISB), the nonprofit pioneers of the systems approach to study the molecular causes of diseases, today announced the successful integration of gene expression data into quantitative physiological simulations. This proprietary capability improves understanding of the gene expression and disease outcomes to radically improve the predictive discernment of the complex nature of disease, yielding insights into novel therapeutic targets, biomarkers, and patient selection that should support a new era of precision medicine.

Entelos and ISB worked together to define a scientifically sound and scalable methodology to provide breakthrough capabilities for both the modeling and systems pharmacology communities. It addresses business-critical problems in both pharmaceutical research and healthcare. “This workflow is transformative for understanding the role of molecular interactions and their impact on pharmaceutical R&D and healthcare decision making,” stated Entelos Founder and CTO, Tom Paterson. “By utilizing our computer models, we are able to use all identified correlations across gene network studies to decipher genetic influence on the disruptions identified as disease. As an example, the new capabilities were able to help us clearly define from a pool of 51 potential biomarkers, and which biomarkers identified non-responders and responders for anti-IL1 therapies for rheumatoid arthritis.”

“The mapping and application of clinical gene expression data sets a new standard and role for quantitative physiological modeling within the drug discovery and development process,” stated Entelos President and CEO, Shawn O’Connor. “It’s only due to the unique depth and breadth of the Entelos quantitative physiological models that these sorts of mappings and analyses can be carried out across the entire pathophysiology of a disease. This is the beginning of truly understanding and leveraging the human genome for therapeutic success”

“As the interconnected features of the disease space become increasingly more visible, we are continuing to look for new ways to decipher the elaborate data that hides therapeutic success“ said Dr. Lee Hood, co-founder and president of Institute for Systems Biology and recipient of the National Medal of Science. “This approach represents a breakthrough capability for deriving insights from those data sets.”

This demonstrated convergence of top-down functional systems biology and bottom-up molecular systems biology provides an approach for using clinical gene expression data to investigate a wide diversity of diseases, to decipher disease complexity, and to understand variability and reduce uncertainty in populations and sub populations. Entelos and ISB are now seeking commercial partners to advance additional existing disease models (Atherosclerosis, Type 2 Diabetes, Hypertension, Rheumatoid Arthritis, etc.) and generate new in silico applications.

Source: Entelos

Congresswoman Barbara Lee Visits Tethys Bioscience

California Congresswoman Barbara Lee recently visited Emeryville-based Tethys Bioscience, developers of the PreDx® test, the predictive multi-biomarker blood test that differentiates adults with prediabetes according to their 5-year likelihood of progressing to type 2 diabetes, enabling clinicians to focus additional attention on those at highest imminent risk of disease conversion.

Myriad Announces Diabetes Collaboration With Sanofi

Myriad Genetics (Nasdaq:MYGN) announced today that Myriad RBM, a wholly owned subsidiary of Myriad Genetics, has entered into a research collaboration with Sanofi, a global and diversified healthcare leader, and Population Health Research Institute (PHRI) at Hamilton Health Sciences and McMaster University. Through this collaboration, Myriad RBM will perform protein biomarker research for the Outcome Reduction with Initial Glargine Intervention (ORIGIN) study, the world’s longest and largest randomized clinical trial in pre- and early diabetes. The relationship between the biomarker results and clinical outcomes will be analyzed by investigators at PHRI.