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Cholesterol Screening Press Release
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cholesterol screening kit
BIOSAFE Laboratories Announces
FDA Approval and NCEP Certification
for Consumer Cholesterol Testing
LAKE FOREST, Ill., Apr 16 /PRNewswire/ -- BIOSAFE Laboratories, Inc. announced today that it has received FDA approval for its consumer collected Cholesterol
Screening Panel micro sample blood test, which includes determinations for Total cholesterol,
HDL, LDL and Triglycerides. Recently, BIOSAFE obtained certification from the National Cholesterol Education Program
(NCEP) by conducting comparisons of results obtained at BIOSAFE Laboratories with those obtained at a CDC Cholesterol Reference Method Laboratory Network
(CRMLN). These tests indicate that all components of the BIOSAFE Cholesterol
Screening Panel including Total Cholesterol,
HDL, LDL and Triglycerides, exceed the rigorous standards set by the NCEP.
Dr. Jack Maggiore, BIOSAFE’s Chief Scientific Officer explains,
"NCEP Certification distinguishes those laboratories and analytical methods which meet stringent guidelines. BIOSAFE is now the only laboratory in the world that has achieved both NCEP Certification and FDA approval for professional and consumer use of a Cholesterol
Screening Panel.”
The BIOSAFE System involves collecting a small sample of blood (three drops) from a finger nick and placing it onto a BIOSAFE patent-pending blood collection card. The card is then mailed to BIOSAFE's
CLIA-Certified Laboratory for testing. "BIOSAFE's enhanced blood collection card minimizes the error typically associated with capillary blood sampling," explains
Maggiore.
"No other FDA-Approved lipid profile testing system combines a quality capillary blood collection system with a quantitative laboratory analysis that meets NCEP guidelines."
“The BIOSAFE Cholesterol Screening Panel was approved by the FDA for professional use in September 2001, and is now the first Self-Collected,
NCEP-Certified, FDA Cleared Cholesterol Screening Panel for capillary dried blood," said BIOSAFE President, David
Fleisner.
“In the last few years, many new pharmaceutical drugs have been introduced to effectively reduce cholesterol. A critical need exists to identify patients who can be appropriately treated with these medications. Further, there is a constant need to monitor the effectiveness of these drugs, and our new Cholesterol
Screening Panel will do that.”
BIOSAFE Laboratories, Inc. with its office and laboratory facilities in Chicago, Illinois, is engaged in the development, manufacturing and marketing of health monitoring and screening products for the diabetes, women's health, men's health and heart health markets. Products are distributed to the professional medical, pharmacy, and disease management markets through BIOSAFE Medical Technologies, Inc. of Lake Forest, IL.
END
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