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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