Tethys Bioscience (Emeryville, Calif.) is commercially launching a fingerstick version of its PreDx diabetes risk stratification test. Validation results demonstrating both comparable accuracy to the whole blood version of the test as well as superior accuracy to fasting glucose tests were presented at the American Association of Clinical Endocrinologists (AACE) annual scientific congress in Phoenix in early May. The PreDx test is a fasting blood test that estimates the five-year likelihood of developing type 2 diabetes in adults with prediabetes. The assay utilizes an algorithm that incorporates seven proteomic biomarkers (blood glucose, glycated hemoglobin, insulin, adiponectin, c-reactive protein, IL-2Rα, and ferritin) as well as age and gender to stratify patients by diabetes risk. Results are presented on a 1 to 10 scale corresponding to an individual’s five-year risk of developing type 2 diabetes, with a higher score indicating a higher risk of progression. Approximately 175,000 venous blood samples have been processed since the PreDx test’s launch in 2009. In the abstract presented at the AACE meeting, the company demonstrated that after calibration, PreDx Finger Stick (FS) values from a set of 80 matched samples showed excellent one-to-one agreement across the PreDx range with no significant differences in area under the […]
Tethys Bioscience (Emeryville, Calif.) is commercially launching a fingerstick version of its PreDx diabetes risk stratification test. Validation results demonstrating both comparable accuracy to the whole blood version of the test as well as superior accuracy to fasting glucose tests were presented at the American Association of Clinical Endocrinologists (AACE) annual scientific congress in Phoenix in early May.
The PreDx test is a fasting blood test that estimates the five-year likelihood of developing type 2 diabetes in adults with prediabetes. The assay utilizes an algorithm that incorporates seven proteomic biomarkers (blood glucose, glycated hemoglobin, insulin, adiponectin, c-reactive protein, IL-2Rα, and ferritin) as well as age and gender to stratify patients by diabetes risk. Results are presented on a 1 to 10 scale corresponding to an individual’s five-year risk of developing type 2 diabetes, with a higher score indicating a higher risk of progression. Approximately 175,000 venous blood samples have been processed since the PreDx test’s launch in 2009.
In the abstract presented at the AACE meeting, the company demonstrated that after calibration, PreDx Finger Stick (FS) values from a set of 80 matched samples showed excellent one-to-one agreement across the PreDx range with no significant differences in area under the curve, positive predictive value, or sensitivity. As with the original PreDx venous blood test, performance of PreDx Finger Stick was significantly better at predicting development of diabetes than fasting glucose.
Drops of blood are collected on an AdvanceDx100 serum separator collection card, enabling the PreDx FS test to be used in primary care and wellness center settings not equipped with phlebotomy. The test is currently run in the company’s CLIA-certified lab. The company says the test allows for more efficient allocation of health care resources toward those at highest risk of progressing to diabetes as well as an effective tool for monitoring the impact of lifestyle interventions in reducing the likelihood of progression.
Pamela Parkes, senior manager, marketing and communications at Tethys, tells DTTR that the test is reimbursed as an out-of-network test by most private payers but that discussions are ongoing to attain in-network status, as well as Medicare reimbursement. Current reimbursement is about $300 per test.
The privately held, venture-backed company is also developing tests to determine risk for first-time heart attack, osteoporotic fracture, and other cardiometabolic diseases.
