Polymer Technology Systems Receives Over-the-Counter Clearance from FDA for HDL-Cholesterol Test
INDIANAPOLIS, Jan. 13 /PRNewswire/ -- Polymer Technology Systems, Inc., a privately held medical diagnostics manufacturer, today announced it has received clearance from the FDA to sell its HDL-cholesterol test strips directly to consumers. The test strip is part of the BioScanner 2000 personal blood chemistry system, designed for the management of diabetes and its complications. "Clearance of our HDL test for the consumer market is a major milestone in our product portfolio," said Tracy Thompson, vise-president of business development. "Now patients with diabetes or cardiovascular disease can monitor their risk factors and better manage their disease at home. The BioScanner is the only device available to consumers which addresses the two largest disease segments in our society, diabetes and heart disease." Cholesterol is a marker for cardiovascular risk, but has many forms in blood. HDL-cholesterol serves as a cholesterol scavenger, removing excess cholesterol from the bloodstream and returning it to the liver. It has been identified as a negative cardiovascular risk factor and a cardiovascular protectant in higher concentrations. The National Cholesterol Education Program (NCEP) recommends patients have their HDL-cholesterol tested as part of their overall risk profile. Addition of the HDL test to the BioScanner test menu allows patients to combine this measurement with the previously cleared total cholesterol measurement. This ratio serves as a relative measure of cardiovascular risk. The BioScanner 2000 is a small hand held blood chemistry system designed for use by professionals and at home. The system consists of a multi-channel analyzer and disposable test strips. Users apply a small drop of blood onto a test strips and insert the strip into the analyzer. Results are returned in a minute or less. Test strips currently available for the BioScanner are glucose, ketone, total cholesterol and HDL-cholesterol. Triglyceride test strips are pending FDA clearance and the company has direct LDL, microalbumin and hemoglobin A1c in development. Polymer Technology Systems, Inc. is dedicated to developing medical diagnostics for the management of diabetes and its complications.
SOURCE Polymer Technology Systems, Inc.
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