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Peer-Reviewed Publications Demonstrate Tethys Bioscience's Ability to Identify those at Highest Risk of Developing Type 2 Diabetes within Five Years

2009-Jul-15 — Diabetes journals publish two definitive papers supporting both the science behind and the clinical performance of lead product, the PreDx™ Diabetes Risk Score (DRS)

EMERYVILLE, Calif. — July 15, 2009 — As diabetes reaches epidemic proportions in the United States, clinicians struggle with a difficult question: how to prioritize their efforts to prevent the progression to diabetes in a population where more than 57 million Americans are currently estimated to be at risk for type 2 diabetes.

Tethys Bioscience, Inc., which has developed a novel tool to help clinicians identify and focus resources on those individuals at highest risk of developing type 2 diabetes within five years, today announced the publication of two peer-reviewed articles that support the science behind and clinical performance of that tool, the PreDx Diabetes Risk Score.

In an article published in the July issue of Diabetes Care, a journal of the American Diabetes Association, Tethys researchers and their academic and medical collaborators demonstrate the validity of the research model that informed development of the PreDx Diabetes Risk Score. The PreDx Diabetes Risk Score incorporates multiple biomarkers from several biological pathways implicated in the development of diabetes to estimate progression to the disease in a given population. The Diabetes Care paper demonstrates the superiority of this approach, when compared to single-risk indicators or clinical models, at estimating 5-year risk of progression to type 2 diabetes.

Tethys also announced today publication in the July issue of the Journal of Diabetes Science and Technology of a new paper that demonstrates the performance of the PreDx Diabetes Risk Score test in the clinical laboratory setting. The study, conducted in the Tethys Bioscience Clinical Lab, demonstrates that the PreDx Diabetes Risk Score is better at risk prediction than impaired fasting glucose, a clinical risk index, or metabolic syndrome, methods that are used to assess likelihood of developing the disease.

The more accurate and convenient measure of type 2 diabetes risk stratification offered by the PreDx DRS provides a valuable tool for clinicians to use in conjunction with clinical factors to identify individuals with the highest risk of developing diabetes in five years, the authors say. These individuals are those for whom prevention programs may reduce the serious health consequences of type 2 diabetes.

“These publications add to a growing body of scientific and clinical evidence in support of the PreDx Diabetes Risk Score,” said Mickey Urdea, Tethys' CEO. “Beyond these foundational studies, we have amassed one of the world's largest collections of blood samples with known cardiometabolic outcomes from a number of significant studies with multi-ethnic U.S. and international populations, and we will use these resources to augment the current body of data with new insights that support the utility of the PreDx Diabetes Risk Score in broad, pan-ethnic populations. In addition, we are planning many more publications concerning our ongoing studies and the application of these clinical samples to a pipeline of Tethys products based on the company's proprietary technology.”

The Diabetes Care and Journal of Diabetes Science and Technology publications are a result of research collaboration between the company and the Research Centre for Prevention and Health, Glostrup Hospital, Copenhagen, Denmark, as well as the Steno Diabetes Center, Copenhagen, Denmark.

About the PreDx™ Diabetes Risk Score

The PreDx Diabetes Risk Score (DRS) is a first-of-its-kind predictive blood test that provides enhanced diabetes risk assessment through the measurement of biomarkers from multiple biological pathways implicated in the development of diabetes, including cardiovascular disease, inflammation, glucose metabolism, obesity, and cell death. It is designed to help clinicians identify individuals at highest risk of developing type 2 diabetes within 5 years.

Performed exclusively by the CLIA-certified Tethys Bioscience Clinical Laboratory, the test analyzes routinely collected blood samples from individuals who are considered at risk for diabetes because of the presence of one or more risk factors. These risk factors include elevated glucose levels, obesity, an inactive lifestyle, family history, high blood pressure, abnormal cholesterol levels, a diagnosis of metabolic syndrome and for some women, a previous history of gestational diabetes.

Information provided by the PreDx DRS enables clinicians to more accurately identify those individuals at highest 5-year risk of developing type 2 diabetes, and may be used by the clinician in conjunction with other clinical indicators to develop an effective diabetes prevention program. The PreDx DRS is indicated for use as an adjunctive test to complement, not replace, other diagnostic and clinical procedures. For more information, visit http://www.predxdiabetes.com.

About Tethys Bioscience

Tethys Bioscience is a predictive personalized medicine company developing novel tests which address the growing global healthcare challenge of chronic diseases such as diabetes. Its first predictive, personalized test — the PreDx Diabetes Risk Score — was introduced in June 2008.

Founded in 2005, the company integrates an experienced management team, innovative research based on sound science, a CLIA-licensed clinical laboratory, and a commercialization team with extensive experience in diagnostic innovation. Partnerships with world class researchers and a solid financial foundation are enabling Tethys to help transform the management of chronic diseases by providing personalized, preventive solutions that aid every constituency: individuals, clinicians and the healthcare system as a whole.

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