Tethys Bioscience Set to Launch PreDx Finger Stick Test
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 […]
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