Arrayit Corporation To Work With Diagnostic Oncology Research Organization (DOCRO) To Obtain FDA Approvals
2013年11月19日 - 10:30PM
ビジネスワイヤ(英語)
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 LifeVisit 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.
Investor Relations:Institutional Marketing Services (IMS)John
Nesbett/Jennifer
Belodeau203-972-9200jnesbett@institutionalms.comjbelodeau@institutionalms.com
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