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Arrayit Corporation Fulfills Clinical Instrumentation Contract with the United States Food and Drug Administration
By GlobeNewswire, December 17, 2018, 05:30:00 AM EDT: Source Arrayit Corporation
Sunnyvale, Dec. 17, 2018 (GLOBE NEWSWIRE) -- Arrayit Corporation (OTC: ARYC), a life sciences and personalized medicine company, reports fulfillment of a clinical instrumentation contract with the United States Food and Drug Administration (FDA), which involves an exacting series of contractual steps including receiving the solicitation, placing the bid, winning the award, receiving the purchase order, shipping the system, gaining an installation and acceptance notice, and reporting FDA approval of payment for fulfillment of the contract. The clinical instrumentation in the FDA contract is the same technology deployed by Arrayit in its Clinical Laboratory Improvement Amendments (CLIA) laboratory licensed by the Centers for Medicare and Medicaid Services (CMS) and the State of California Department of Public Health (CDPH) for allergy and dietary wellness testing and pipeline tests for ovarian cancer and Parkinson’s Disease (PD).
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, signed allergy testing contracts with more than 300 medical clinics, received approval for in-store promotions by a major retailer, announced allergy testing partnerships with major allergy therapeutics providers, received approval for direct Medicare billing by CMS, launched the Patient Data Solutions allergy portal for doctors and clinics, celebrated 25 years of company operations, and announced an allergy testing services agreement with a major health and wellness provider. Fulfilling the FDA clinical instrumentation contract strengthens the company’s relationship with the agency that ensures the safety of medical devices and pharmaceutical consumer healthcare products exceeding $1,000,000,000,000 ($1 trillion) in annual revenues.
Chief Executive Officer Rene Schena states, “Fulfilling this contract with the nation’s leading healthcare regulatory agency adds transparency and allows independent benchmarking of our clinical platform by top scientists at the FDA. We anticipate that the regular use of Arrayit’s instrumentation will have a positive impact on FDA submissions and clinical approvals going forward.”
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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