Orion Genomics launches clinical diagnostics lab, granted CLIA certification

For Immediate Release
February 7, 2014

Carolyn Hawley
Canale Communications for Orion Genomics
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St. Louis, Missouri − February 7, 2014 − Orion Genomics, a leading developer of epigenetic − based diagnostics, announced today the receipt of certification by the College of American Pathologists, for meeting standards of excellence in the practice of laboratory medicine. On April 9, 2013, Orion Genomics also received licensure and certificate of registration from the State of Missouri as a CLIA laboratory, and launched the Orion Genomics Clinical Labs. The Centers for Medicare & Medicaid Services (CMS) ensures high − quality standards of diagnostic testing on humans through regulatory oversight through the Clinical Laboratory Improvement Amendments of 1998 (CLIA).

”CAP accreditation and CLIA certification are critical steps in the validation of our proprietary colon cancer risk test in large prospective cohorts, which can now begin under the highest performance standards in the Orion Genomics Clinical Laboratory”, said Nathan Lakey, President and Chief Executive Officer of Orion. ”These achievements also enables us to market assay design and validation services to companies with novel diagnostics in development.” The DNA molecule not only contains information based on its sequence of As, Ts, Gs and Cs but also has a second layer of information (or epigenetic layer) written on top of the DNA sequence. The second layer is based on the addition of methyl groups to the DNA molecule’s backbone, which creates a binary language that controls whether or not a gene is turned on or off, also called gene silencing. Orion’s colon cancer risk test measures the loss of imprinting (LOI) of the insulin−like Growth Factor II gene , a sporadic epigenetic defect which occurs in ~10% of the population and leads to an increased expression of a potent growth factor, a marker which may be predictive of future cancer risk. Orion exclusively licensed a portfolio of patents from the Johns Hopkin’s University covering LOI testing, and is collaborating with leading Hopkins researchers to design high performing molecular assays for LOI testing

About Orion Genomics

Orion Genomics, the Second Code Company, develops epigenetic research tools and molecular diagnostic products to fulfill the promise of personalized medicine. Orion’s lead product is a simple blood-based test that is being developed to identify people at elevated risk for colorectal cancer. The company has active biomarker discovery programs in cancers of the bladder, breast, lung, ovaries and colon. The company offers genomics services to the medical, agricultural and bio−fuels research communities. Orion Genomics is located in the Center for Emerging Technologies in St. Louis.