Corporate - Media & Press - Press Release
Arrayit Corporation To Work With Diagnostic Oncology Research Organization (DOCRO) To Obtain FDA Approvals.
Arrayit Corporation, November 19, 2013 8:30 AM, EST
SUNNYVALE, Calif.--(BUSINESS WIRE) - Arrayit Corporation (ARYC) announced today that the company has signed a Professional Services Master Agreement (PSMA) with Diagnostic Oncology Research Organization (DOCRO, Inc.). Arrayit and DOCRO will use the PSMA as a blueprint for the submission and approval of the company's OvaDx® Pre-Symptomatic Ovarian Cancer Monitoring and Screening Test, as well as a secondary Parkinson€’s Diagnostic Test and other pipeline tests.
Arrayit is a life sciences and molecular diagnostics company engaged in the business of commercializing in vitro diagnostic (IVD) medical devices used to detect and monitor a variety of medical disorders. The company uses microarray-based methods and systems to detect protein and nucleic acid biomarkers useful as aids in the detection, diagnosis, monitoring, therapy effectiveness determination, and prognosis of a variety of medical disorders, diseases, and conditions. As previously announced, Arrayit will utilize DOCRO-facilitated CLIA and ISO 9001 and ISO 13485 certified laboratories in its new company headquarters in Sunnyvale, California, USA for the OvaDx® and PDx FDA submission processes and for processing patient test samples upon FDA approval and commercialization.
DOCRO provides professional services to life sciences, diagnostics, biotechnology, therapeutic, medical device, and IVD medical device manufacturers and users of such devices such as clinical testing laboratories, in the form of tactical and strategic advice related to marketing claims, reimbursement, and regulatory requirements including the design and conduct of clinical trials with the United States Food and Drug Administration (FDA). DOCRO has assisted companies in more than 100 IVD clinical trials, and has secured more than 50% of the premarket approval (PMA) certifications for the entire IVD industry in the past 17 years with an unparalleled 100% FDA track record.
About Arrayit Corporation
Arrayit utilizes its patented and proprietary microarray platform to lead and empower 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.
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Safe Harbor Statement
We have identified forward-looking statements by using words such as "expect", "believe", and "should". Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company's Form 10-K for the fiscal year ended December 31, 2012 and in Form 10-Q for the quarterly period ended June 30, 2013.
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