10/12/2011 Tethys is Granted New York State Laboratory Permit for PreDx® Diabetes Risk Score
Approval Validates the Quality and Reliability of the Tethys Clinical Laboratory
EMERYVILLE, CA – October 10, 2011 – Tethys Bioscience announced today that the New York State Department of Health has granted a Clinical Laboratory Permit to the CLIA-certified Tethys Clinical Laboratory (TCL) approving use of the PreDx® Diabetes Risk Score (DRS) test on samples obtained from state residents. New York’s clinical laboratory evaluation and validation process is designed to ensure the accuracy and reliability of laboratory results and compliance with departmental regulations and standards, and is considered to be the most thorough and rigorous laboratory review process in the country. Allowance of the permit provides important validation for the quality and reliability of operations at the Tethys Clinical Laboratory.
By obtaining this permit, Tethys will be able to provide the large New York population with access to PreDx DRS. In multiple studies, PreDx DRS has been shown to be an accurate and valuable tool in identifying individuals at high risk of developing type 2 diabetes within five years, as well as monitoring their response to therapeutic and lifestyle intervention. By identifying individuals at greatest risk, physicians are able to focus their efforts on those individuals at greatest risk of progressing to type 2 diabetes.
Randy Strahan, Tethys President and Chief Executive Officer, commented: “This is an exciting time for Tethys. With this permit, we can now respond to the considerable interest in the PreDx DRS test from New York-based physicians and employers. The PreDx test is now available to customers throughout the United States.”
About PreDx® Diabetes Risk Score
The PreDx Diabetes Risk Score (DRS) provides enhanced risk stratification through the measurement of multiple biomarkers linked to pathways of diabetes progression. PreDx DRS was developed using a unique approach to quantifying biomarkers suspected of playing roles in diabetes development. Tethys methodology enabled evaluation of many biomarkers utilizing very small amounts of blood from select and well-characterized large study cohorts with known diabetes outcomes. The company then determined the combination of these biomarkers with an algorithm that best identified an individual’s risk of developing type 2 diabetes within five years. PreDx DRS has been validated by the Tethys Clinical Laboratory (TCL) in several large populations. The test uses standard immunoassay and clinical chemistry formats, sample collection and shipment methods. Currently performed exclusively by the CLIA-certified TCL, the test generates a Diabetes Risk Score between 1 and 10 that corresponds to an absolute percentage risk of developing disease.
Tethys is a cardiometabolic diagnostics company that creates and commercializes breakthrough biomarker-based blood tests that predict imminent disease risk and enable targeted intervention to preempt the onset of chronic conditions such as type 2 diabetes. Tethys introduced its first product—PreDx® Diabetes Risk Score—to the market in 2008, and initiated sales in 2009. The Tethys PreDx DRS platform includes products in development to determine risk for first-time heart attack, osteoporotic fracture and other cardiometabolic diseases with the goal of improving health outcomes and reducing the devastating economic impact that debilitating, preventable diseases have on individuals and society. For more information about Tethys and PreDx DRS, please visit www.tethysbio.com.