EMERYVILLE, Calif. and PHOENIX, May 28, 2013 /PRNewswire/ -- 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."
About the PreDx® Test
PreDx® is a fasting blood test that predicts the 5-year likelihood of developing type 2 diabetes in adults with prediabetes. The test measures seven biomarkers implicated in the development of type 2 diabetes – glucose, hemoglobin A1C, insulin, adiponectin, C-Reactive Protein, Ferrtin and Interleukin 2-Reactive alpha – and applies a proprietary algorithm that combines biomarker results with patient age and gender to generate a "personalized" numerical score on a scale of 1 to 10, that corresponds to an individual's 5-year risk of developing type 2 diabetes, with a higher score indicating a higher 5-year risk of progression. Validated by the Tethys Clinical Laboratory (TCL) in a number of large populations, PreDx has been shown to be more accurate than fasting plasma glucose and hemoglobin A1C screening tests for predicting diabetes outcomes, and to be a reliable method for monitoring the impact of lifestyle interventions on a patient's risk status. PreDx Test Kits for either venous or capillary blood sample collection are provided by the CLIA‐certified Tethys Clinical Laboratory located in Emeryville, CA. For more information about the PreDx test, and to obtain test supplies, please visit www.predxdiabetes.com.
About Tethys Bioscience, Inc.
Tethys Bioscience is a cardiometabolic diagnostics company that creates and commercializes biomarker‐based blood tests that predict imminent disease risk and enable targeted intervention to forestall the onset of preventable chronic conditions such as type 2 diabetes. Tethys initiated sales of its first product – the PreDx® Test – in 2009, and has processed 180,000 tests to date. Additional products are in development to determine risk for first‐time heart attack, osteoporotic fracture and other cardiometabolic diseases. For more information about Tethys, please visit www.tethysbio.com.
CONTACT: Pamela Parkes
Tethys Bioscience, Inc.
SOURCE Tethys Bioscience, Inc.