- Sections :
- Crime & Public Safety
- Restaurants & Food
- Sports
- More
Power3 Receives CLIA Compliance Recertification
Proteomics Company Certified to Continue Offering Blood Serum Based Tests, BC-SeraPro™ and NuroPro®
THE WOODLANDS, Texas -- Power3 Medical Products, Inc. (OTCBB: PWRM), a leading proteomics company specializing in the development and commercialization of diagnostic tests for the early detection of breast cancer and neurodegenerative diseases, has received its Clinical Laboratory Improvement Amendments (CLIA) compliance recertification following a CLIA regulatory inspection.
CLIA are U.S. federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. In 1988, Congress passed CLIA to establish standards for all laboratory testing and to insure accuracy, reliability, and timeliness of patient test results. The CLIA Program sets standards and issues certificates for clinical laboratory testing. The FDA has assumed primary responsibility for performing the complexity categorization functions that include the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories based on their potential risk to public health.
Power3 earned its CLIA recertification to offer high complexity tests after meeting standards for knowledge, training, expertise, quality control, quality assurance, and testing proficiency. With CLIA recertification, Power3 is able to continue offering its blood serum based tests, BC-SeraPro™ and NuroPro®.
“We are pleased to have earned our CLIA recertification,” said Dr. Essam Sheta, CLIA Laboratory Director of Power3. “We look forward to continuing to move ahead with offering our various proteomics diagnostics tests.”
“Receipt of Power3’s CLIA recertification of compliance is a major milestone,” said Steven Rash, Chief Executive Officer and Chairman of Power3. “This achievement reflects our desire to offer the highest quality proteomic tests in our continuing mission to commercialize our proteomic discoveries and serve the medical and scientific communities.”
About Power3 Medical Products
Power3 Medical Products, Inc. (OTCBB: PWRM), is a leading proteomics company engaged in the commercialization of protein biomarkers, pathways, and mechanisms of diseases through the development of diagnostic tests and drug targets for cancer and neurodegenerative diseases. Power3’s patent-pending technologies are being used to develop screening and diagnostic tests for the early detection and prognosis of disease, identify protein biomarkers, and drug targets. Diagnostic tests are targeted toward markets with critical unmet needs in areas such as breast cancer and neurodegenerative disease. Power3 has signed its first distribution agreement to provide its blood serum diagnostic for breast cancer, BC-SeraPro™, in twelve Middle Eastern countries before the end of 2007. Power3 operates a state-of-the-art CLIA certified proteomics laboratory in The Woodlands (Houston), Texas. The Company is preparing to commercialize its IP portfolio, centering on the 543 biomarkers the Company has discovered from a broad range of diseases as the basis of blood-based tests for breast cancer, ALS, Alzheimer’s, and Parkinson’s Diseases.