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.
- Powerful Science for Life
Visit http://arrayit.com/
for more information.
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.
Copyright Business Wire 2013