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.
Read more about Arrayit Corporation To Work With Diagnostic Oncology Research Organization (DOCRO) To Obtain FDA Approvals - BWWGeeksWorld by www.broadwayworld.com
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