Baltimore, Maryland, 29 August 2017
PapGene, Inc. announced today that its clinical laboratory, located in Baltimore, MD, has received Clinical Laboratory Improvements Amendments (CLIA) certification of compliance from the Centers for Medicare and Medicaid Services (CMS). PapGene’s laboratory has also passed inspection by the Maryland Department of Public Health and is now permitted to provide information for the diagnosis, prevention, and treatment of disease or impairment or assessment of health.
PapGene will use its CLIA-certified laboratory to commercialize early-stage cancer diagnostic tests using massively parallel sequencing (MPS) and a proprietary error-reducing technology. “Receiving our CLIA Certification is a significant milestone for PapGene as it will facilitate PapGene’s entry into the commercial diagnostic test market”, said Howie Kaufman, PapGene’s CEO.
PapGene’s Chief Scientific Officer Isaac Kinde, M.D., Ph.D., further explained the significance of the recently awarded certification by saying “The receipt of CLIA certification has demonstrated PapGene has implemented the necessary lab procedures, quality controls and personnel training to perform clinical tests that affect patient care”.
Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. CLIA certification is issued to a laboratory once the appropriate State Department of Health conducts an inspection and determines that the laboratory is compliant with all applicable CLIA requirements.
About PapGene, Inc.
PapGene is a molecular diagnostic company dedicated to advancing the early detection of curable cancers. The company is developing innovative tests that uncover early-stage cancers from the analysis of easily accessible body fluids. The company’s assays detect cancers while they are still surgically resectable by identifying the presence of genetic defects (acquired mutations) that drive cancer growth.
For more information, please visit http://www.papgeneinc.com
Chief Executive Officer
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