NEW YORK (GenomeWeb News) – Arrayit said today it has inked a professional services master agreement with Diagnostic Oncology Research Organization to aid it in obtaining approval from the US Food and Drug Administration for its tests.
The agreement will serve as a blueprint for submitting Arrayit's OvaDx presymptomatic ovarian cancer monitoring and screening test, a secondary Parkinson's disease diagnostic test, and other tests in the company's pipeline.
Last week, Arrayit announced a deal with DOCRO to help in the implementation of ISO and CLIA registration and certification for Arrayit's new headquarters in Sunnyvale, Calif. The new labs will be used for the OvaDx and PDx FDA submissions, as well as for patient test sample processing and commercialization upon FDA approval, Arrayit said.
The new labs are scheduled to open Jan. 1, 2014.