HAYWARD, Calif., June 27 /PRNewswire-FirstCall/ -- Cholestech Corporation , a leader in point of care testing, announced today that the Cholestech LDX(R) System has been certified by the Cholesterol Reference Method Laboratory Network (CRMLN). This certification validates that the system consistently meets the gold standard for accuracy and reproducibility developed by the Centers for Disease Control and Prevention (CDC) for the measurement of total cholesterol and HDL cholesterol consistent with National Cholesterol Education Program (NCEP) analytical goals.
According to the American Heart Association, cardiovascular disease has been the number one cause of death in the United States for more than 100 years. Some 2,500 Americans die of heart disease every day -- equal to the next five causes of death combined. While smoking and other risk factors have declined in recent years, high cholesterol remains one of the most prevalent among all ages, sexes and ethnicities. The NCEP, developed by the National Institutes of Health, recommends that more than 200 million Americans need to be screened for cholesterol annually.
"In order for physicians to confidently apply the clinical guidelines issued by the Adult Treatment Panel III, the methods used to measure lipid levels must conform to rigorous performance standards, whether you're talking about a clinical laboratory or a point of care testing device," said Dr. Santica Marcovina, Research Professor of Medicine at the University of Washington and Director of the Northwest Lipid Metabolism and Diabetes Research Laboratories in Seattle. "The goal of the CRMLN method certification is to ensure that comparable cholesterol results are obtained, independent of the methods used for the measurement. Therefore, the ultimate benefit of the program is improved patient care, and based on this certification, Cholestech meets these standards."
The CRMLN was established by the CDC to ensure that diagnostic products are properly calibrated to the National Reference System for Cholesterol. Certified products are thoroughly evaluated based on demonstrated ability to consistently meet CDC standards for accuracy and reproducibility. The Food and Drug Administration has recognized the value of the CRMLN's certification program and encourages manufacturers to certify their products through the CRMLN.
"Priding itself on offering tremendous value in a system priced under $2,100, Cholestech provides the highest quality diagnostic tools that can generate lab-accurate results in minutes. This gives physicians the ability to counsel patients in the same office visit," said Warren E. Pinckert II, president and CEO of Cholestech. "The CRMLN certification validates this accuracy and confirms that the LDX System meets the gold standard for the measurement of lipids."
Using a simple finger-stick, the Cholestech LDX point of care system supports the measurement of cholesterol and other lipid tests, glucose and liver enzymes, ALT and AST, and soon, high sensitivity C-reactive protein (hs-CRP). This enhances the ability to quickly identify patients with the most prevalent risk factors for heart disease and offer treatment or counseling in the same office visit. Generating comprehensive, lab-accurate results in minutes, the LDX System enables physicians to focus on getting patients on the right treatment sooner and making sure they stay on the right therapeutic mix, rather than chasing down lab results.
About Cholestech
Cholestech is committed to enabling people to lead longer, healthier and more active lives. Cholestech provides easy to use, accessible diagnostic tools and information to health care practitioners in over 35 countries around the world. Cholestech offers efficient and economic diagnostic testing for cholesterol and related lipids, blood glucose and A1C, and liver function at the point of care. Health care providers can use the CLIA-waived Cholestech LDX(R) and GDX(TM) Systems to initiate and monitor the progress of patient therapy. By providing effective disease management solutions, Cholestech's goal is to be a leading provider of diagnostic tools and information for immediate risk assessment and therapeutic monitoring of heart disease and diabetes.
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