Multi-Lipid Panel Test CLIA Waiver

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PTS ANNOUNCES CLIA WAIVER CLEARANCE FOR LIPID PANEL TESTING

Indianapolis, Indiana - October 22, 2002 - Polymer Technology Systems (PTS) announced today that the company has received a waiver under the Clinical Laboratory Improvement Act (CLIA) from the Food and Drug Administration (FDA) for its new lipid panel test strip. This classification establishes that the PTS PANELS™ Lipid Panel Test Strip, run on the company's PTS CardioChek™ P·A test system, provides accurate, reliable and timely patient test results.

CLIA, passed by Congress in 1988, is a user fee funded program that establishes quality standards for all laboratory testing. The program is run by the Centers for Medicare and Medicaid Services (CMS). The FDA assigns the waiver to commercially marketed in vitro diagnostic tests based on their public health risk.

PTS PANELS™ Lipid Panel Test Strips provide lipid results (total cholesterol, HDL cholesterol, triglycerides, and calculated LDL cholesterol) from a single, 35 to 40 µL drop of blood. PTS PANELS Lipid Panel Test Strips enable healthcare professionals to easily test and immediately counsel their patients on lipid-lowering therapies, to understand their risk for developing coronary heart disease, their medication regimen, and the benefits of long-term persistence of therapy.

The American Heart Association, Heart and Stroke Statistical Update 2002, estimates that 102 million adult Americans have total cholesterol levels above the desirable level of 200 mg/dL. Of this total, 41 million have levels above 240 mg/dL, which is considered being at high risk for developing coronary heart disease, the leading cause of death in the U.S. The first step in managing this disease, according to National Cholesterol Education Program (NCEP) guidelines, is risk assessment, including regular determinations of a fasting, lipoprotein profile.

"The Lipid Panel Test Strip is an example of our ongoing efforts to provide a more thorough, efficient and cost effective testing alternative for the professional marketplace," said Bob Huffstodt, President of Polymer Technology Systems. "Now you can use just one strip that gives four critical blood test results - in around two minutes. Our portable system and non-refrigerated storage test strips make lipid profile testing more efficient. The Lipid Panel Test Strip along with our single test strips provide a comprehensive approach to monitoring cardiovascular risk factors while fully complying with the new CMS reimbursement guidelines."

The portable CardioChek P·A whole blood test system provides efficient and affordable point-of-care testing for the CLIA-Waived physician office laboratory market. This system is capable of performing both lipid panel testing as well as single test capabilities for total cholesterol, HDL cholesterol, triglycerides, glucose, ketones, and creatinine. The CardioChek P·A system meets monitoring requirements of the NCEP.

Founded in 1992 and based in Indianapolis, Indiana, PTS is an emerging leader in developing innovative diagnostic products that provide more information for better health. PTS products address cholesterol/lipid screening, diabetes monitoring, and renal function testing markets for both professional testing and consumer self- worldwide.

CARDIOCHEK and PTS PANELS are trademarks of Polymer Technology Systems, Inc.