Abstract on PreDx® Finger Stick Performance Chosen for Oral Presentations at AACE Annual Scientific & Clinical Congress

EMERYVILLE, Calif. and PHOENIX, May 3, 2013 /PRNewswire/ -- Tethys Bioscience has announced the selection of their abstract "PreDx Finger Stick: Diabetes risk stratification of prediabetic patients from conveniently collected capillary blood," for Oral Presentation on May 4, 2013, at the 22^nd Annual Scientific and Clinical Congress of the American Association of Clinical Endocrinologists (AACE).

PreDx is a multi-biomarker fasting blood test that predicts the 5-year likelihood of developing type 2 diabetes in adult patients with prediabetes. In addition to enabling the more cost‐efficient allocation of healthcare resources toward those at highest risk of progressing to diabetes, PreDx testing has been shown to be an effective tool for monitoring the impact of lifestyle interventions in reducing the likelihood of progression.

Findings to be presented at the AACE Congress show that the precision and accuracy of the new PreDx Finger Stick, which uses capillary blood collected on an ADx 100 serum separator card, is equivalent to that of the PreDx test using venous blood for the stratification of patients with prediabetes according to their 5-year likelihood of progressing to type 2 diabetes. As with PreDx venous, performance of the PreDx Finger Stick is also statistically significantly better than fasting glucose alone for predicting the development of type 2 diabetes.

Ted Tarasow, PhD, Senior Vice President of Research and Development at Tethys Bioscience, had these comments regarding the development and validation of the PreDx Finger Stick "Fingerstick blood offers significant logistical advantages for sample collection but also introduces certain technical challenges.  Because the PreDx score is a quantitative measure of risk and uses quantitative inputs of each of the seven biomarkers, assay accuracy and precision are important to overall PreDx performance.  Through careful assay development and validation with our partners at Clinical Reference Laboratory in Lenexa, Kansas, including performing method comparison studies between matched sets of venous and finger stick blood samples, we demonstrated equivalent clinical performance of the PreDx score using both sample sources."

Juan Frias, MD, Chief Medical Officer at Tethys, concurs. "PreDx is a valuable clinical tool that, until now, has only been accessible to practices with phlebotomy. We're excited about the introduction of a finger stick method of sample collection that offers performance characteristics equivalent to the PreDx venous test, because it will facilitate expanded test use in both the primary care setting and in employer wellness initiatives."

About the PreDx® Test

Introduced in 2008, PreDx® is a fasting blood test that estimates 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. With the introduction of PreDx Finger Stick in June, 2013, the PreDx test can now be performed with either a venous or capillary blood sample. PreDx Test Kits for both collection methods 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 the American Association of Clinical Endocrinologists (AACE)

The American Association of Clinical Endocrinologists (AACE) is the largest association of clinical endocrinologists in the world, with a membership of more than 6,500 endocrinologists in the United States and abroad. The majority of AACE members are certified in endocrinology, diabetes and metabolism and concentrate on the treatment of patients with endocrine and metabolic disorders including diabetes, thyroid disorders, osteoporosis, growth hormone deficiency, cholesterol disorders, hypertension and obesity. The AACE Annual Scientific and Clinical Congress provides a forum for continuing education, and discussion of innovations and cutting-edge research in endocrinology. For more information on the Association, visit our site at www.aace.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 chronic conditions such as type 2 diabetes. Tethys initiated sales of its first product – the PreDx® Test – in 2009, and has processed 175,000 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.

About Clinical Reference Laboratory, Inc. (CRL)

Established in 1979, Clinical Reference Laboratory, Inc. is one of the largest privately owned centralized laboratories in the United States, processing and reporting over 100 million test results annually for Clinical Trials, Genomics, Molecular, Toxicology, Wellness and the Insurance clients. CRL's main laboratory is located in Lenexa, Kansas, and has a satellite location near Cambridge, UK. Additional information is available at www.crlcorp.com.

CONTACT: Pamela Parkes
Tethys Bioscience, Inc.
[email protected]
1‐888‐483‐8497

SOURCE Tethys Bioscience, Inc.