Arrayit Corporation Ships Clinical Instrumentation and Software to the United States Food and Drug Administration
09/24/2018 | 05:31am EST
Sunnyvale, Sept. 24, 2018 (GLOBE NEWSWIRE) -- Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, reports the shipment of clinical instrumentation and quantification software to the United States Food and Drug Administration (FDA). Arrayit uses the same instrumentation and software to test for allergy and food intolerance as well as pipeline indications for ovarian cancer and Parkinson’s Disease (PD). Testing is performed in the company’s Clinical Laboratory Improvement Amendments (CLIA) laboratory licensed by the California Department of Public Health (CDPH) and the Center for Medicare and Medicaid Services (CMS).
Arrayit recently completed an allergy testing pilot program for a top retail chain, established a nationwide network of 1,700 allergy sales professionals, met with top officials at the FDA regarding approval of a major product line, reported the sale of clinical instrumentation to the FDA, signed allergy testing contracts with a consortium of 178 medical clinics, received approval for in-store promotions by a major retailer, announced allergy testing partnerships with major allergy therapeutics providers and was approved for direct Medicare billing by CMS. The clinical instrumentation and software shipped to the FDA, which regulates consumer products exceeding $1,000,000,000,000 ($1 trillion) in annual revenues, allows hands-on use by FDA scientists.
Chief Executive Officer Rene Schena states, “Arrayit’s personalized medicine initiatives are purposefully designed to use simple, non-invasive finger stick tests. That the FDA chose to purchase the same clinical microarray instrumentation and software that Arrayit uses daily enhances the credibility of our approach. Microarrays are invaluable tools that are transforming healthcare today.”
About Arrayit Arrayit Corporation, headquartered in Sunnyvale, California, leads and empowers the research, biotechnology, pharmaceutical, clinical and healthcare sectors through the discovery, development and manufacture of proprietary life science and personalized medicine products and services to advance biomedical research and improve wellness and human health. Please visit www.arrayit.com for more information.
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