Tethys Surpasses Major Commercial Milestone with More Than 35,000 PreDx® DRS Tests Sold To Date
Emeryville, CA -- March 17, 2011 -- Tethys Bioscience, Inc. announced that sales of its PreDx® Diabetes Risk Score (DRS) test have exceeded 35,000 units sold since the product was commercially introduced in 2009. PreDx DRS is a multimarker blood test that enables accurate identification of patients who have a high risk of developing type 2 diabetes within five years. Tethys sells PreDx DRS directly to physicians in the U.S., including large, regional multi-specialty provider organizations as well as primary care physicians in smaller group practices. Many of these practices include large numbers of patients at high risk for developing type 2 diabetes but who require aggressive motivation to adopt life-style and behavioral changes that can delay or forestall the onset of disease. PreDx DRS, which accurately stratifies patients at imminent risk of developing type 2 diabetes, enables physicians to focus resources on those patients most in need of risk mitigation intervention and, through retesting, to determine improvements in their risk profile based on reduction of their risk scores.
“Sales of PreDx DRS continue to gain momentum through our direct commercialization efforts and as word spreads through the physician community about the dramatic impact the test can have on reducing patients’ risk of developing type 2 diabetes and its complications,” said Mickey S. Urdea, Ph.D., chairman and chief executive officer of Tethys. “As we continue to partner with healthcare providers, payers and employers, and demonstrate the risk reduction and health economic benefits of using PreDx DRS, we believe that market uptake of this product will accelerate and become a mainstay of general and family medical practice.”
“When patients actually see their risk graphically represented on a 1 to 10 scale in their PreDx DRS risk score, they feel compelled for the first time to take action,” said Edward S. Kersh, MD, FACC, Chief of Cardiology at St. Luke’s Hospital in San Francisco. “Type 2 diabetes is not inevitable, and identifying patients before the disease sets in allows us to initiate treatment that can help them avoid the disease. PreDx DRS has greatly increased my ability to motivate patients to take steps that will improve their lives.”
About Type 2 Diabetes
Type 2 diabetes mellitus is a major public health epidemic. According to the United States Centers for Disease Control and Prevention, diabetes affects nearly 26 million people in the United States or 8.3% of the population. Diabetes is the seventh leading cause of mortality in the U.S., a major cause of heart disease and stroke, and the leading cause of kidney failure, nontraumatic lower-limb amputations and new cases of blindness among adults in the U.S. The direct and indirect costs of diabetes in the U.S. exceeded $174 billion in 2007, including $58 billion in indirect costs (disability, work loss, premature mortality). Medical expenditures for people with diabetes are more than two times higher than for people without diabetes. Worldwide, in 2000, diabetes affected an estimated 171 million people and this figure is projected to rise to 366 million by 2030, propelled by increases in age, obesity, and urbanization of the world’s population.
In 2005–2008, based on fasting glucose or A1c levels, 35% of U.S. adults aged 20 years or older had prediabetes (50% of those aged 65 years or older). In 2010, it is estimated that 79 million Americans aged 20 years or older had prediabetes. The Diabetes Prevention Program (DPP), a large prevention study of people at high risk for diabetes, showed that lifestyle intervention to lose weight and increase physical activity reduced the development of type 2 diabetes by 58% during a 3-year period. The reduction was even greater, 71%, among adults aged 60 years or older.
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