Arrayit Corporation (OTC: ARYC) announces that it has engaged the professional services of the prestigious firm Diagnostic Oncology Contract Research Organization (DOCRO) to assist the company in implementing International Organization of Standardization (ISO) and Clinical Laboratory Improvement Amendments (CLIA) registration and certification. DOCRO provides a wide range of consulting services to diagnostics companies including regulatory strategy expertise, FDA negotiation, clinical trial protocol development, clinical site recruitment, clinical trial management, statistical planning and analysis, final clinical trial reports, regulatory submissions and quality manufacturing audits.
DOCRO is the leading contract research organization (CRO) in the country specializing in the commercialization of diagnostic biomarker technologies, which include the Arrayit OvaDx® Pre-Symptomatic Ovarian Cancer Test and the company’s pipeline PDx™ Pre-Symptomatic Test for Parkinson’s Disease. DOCRO has assisted in more than 100 FDA in vitro diagnostic (IVD) clinical trials, and has secured more than half of the premarket approval certifications for the entire IVD industry in the past 17 years with an unparalleled 100% FDA track record.
Arrayit has hired DOCRO to assist in obtaining ISO 9001, ISO 13485 and CLIA certification, which are three of the most widely used quality management systems in the world, offering the benefits of improved inventory control, increased operational efficiency, and compliance with the United States Food and Drug Administration (FDA) for the manufacture of medical devices. Arrayit's ISO and CLIA-certified laboratories will be located in the company's new Sunnyvale, CA corporate headquarters, scheduled to open on January 1, 2014.
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About Arrayit Corporation
Arrayit Corporation is a Sunnyvale, California-based company leading and empowering the genetic, research, pharmaceutical, and diagnostic communities through the discovery, development, and manufacture of proprietary life science technologies and consumables for disease prevention, treatment and cure. The company’s innovative products and services help scientists and clinicians explore the human genome as well as the genomes of plants and animals. Arrayit’s products are used by every major research center in the world.
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