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 CorporationArrayit 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.