Indianapolis-Based PTS Obtains CRMLN Certification for its Total Cholesterol Test
INDIANAPOLIS, April 23 // -- Polymer Technology Systems Inc. (PTS) announces today it has obtained certification by the Cholesterol Reference Method Laboratory Network (CRMLN) for its Cholesterol Test Strip for use at Point-of-Care by physicians, pharmacies, and other healthcare professionals, as well as by consumers at home.
The Cholesterol Reference Method Laboratory Network (CRMLN) certifies manufacturers of clinical diagnostic products that measure Total Cholesterol using reference methods or designated comparison methods that are rigorously standardized to the Centers for Disease Control and Prevention (CDC) reference methods. The Food and Drug Administration (FDA) has recognized the value of the CRMLN's certification program and encourages manufacturers to certify their products through the CRMLN. The Division of Laboratory Sciences (DLS) maintains lists of the clinical diagnostic products that have been certified by the CRMLN.
"We are very proud to make this announcement," says PTS CEO Robert Huffstodt, "as it again validates the accuracy of our cholesterol test. After widespread acceptance by professionals around the world, we recently made a version of our CardioChek(R) system available to consumers at retailers across the country for the first time. Those who have already purchased a system and those thinking about purchasing a system can rest assured that our cholesterol test meets the requirements of this difficult certification process."
How Cholesterol testing works with the CardioChek system
Total Cholesterol is an important factor in calculating risk for cardiovascular disease, stroke, or heart attack. People with high cholesterol typically are not aware they have a problem because there are no symptoms. According to the American Heart Association, nearly 107 million Americans have dangerously high cholesterol levels and may be at increased risk for a heart attack or stroke. The Total Cholesterol Test Strips from PTS provide a simple, immediate means for both professionals and consumers alike to detect and monitor high levels of cholesterol in the blood.
PTS Panels(R) Total Cholesterol Test Strips are used with the portable CardioChek brand handheld analyzers. A color-coded MEMo chip(TM) is placed into the meter, the test strip is inserted, and a drop of the patient's blood is applied to the strip. In about two minutes, results appear on the analyzer as a numeric value that can be compared with standard guidelines to determine whether the patient is within recommended limits or may require cholesterol- lowering therapy or lifestyle changes.
In addition, PTS has recently received 510k clearance from the Food and Drug Administration for a new HDL cholesterol Test Strip technology currently marketed under the PTS Panels(TM) brand.
About Polymer Technology Systems Inc. (PTS)
Polymer Technology Systems Inc. is a global company headquartered in Indianapolis, Ind., with sales offices in Africa, Australia, Europe, Latin America, the Middle East, and the Pacific Rim. PTS developed and markets Point-of-Care diagnostic products including the CardioChek consumer and CardioChek PA professional handheld analyzers. PTS has developed PTS Panels Test Strips for home use with the CardioChek to measure Total Cholesterol, HDL Cholesterol, Glucose, Triglycerides, or Ketone. PTS also offers tests for direct LDL Cholesterol, Creatinine, a complete Lipid Panel, and other combination test strips for professional use with the CardioChek PA. For more information visit www.cardiochek.com/.
Source: Polymer Technology Systems Inc.
CONTACT: Michelle Jacquay of Polymer Technology Systems, Inc.,
+1-317-870-5610, mjacquay@cardiochek.com
Web site: http://www.cardiochek.com/
