Arrayit Corporation Taps DOCRO to Facilitate FDA Approval of OvaDx
Published: Mar 22, 2010
SUNNYVALE, CA--(Marketwire - March 22, 2010) - Arrayit Corporation (OTCBB: ARYC), a leader in life sciences, healthcare and molecular diagnostics, announced today that the company has appointed DOCRO, Inc. of Seymour, Connecticut, to assist in obtaining FDA approval for OvaDx. DOCRO has steered nearly 100 In Vitro Diagnostic (IVD) clinical trials through the Food and Drug Administration in the past 12 years, along with 39 pre-market approval (PMA) and 46 510(k) applications. DOCRO has an unparalleled 99% success rate with the FDA.
Arrayit's OvaDx Pre-Symptomatic Ovarian Cancer Test will be the market's first comprehensive diagnostic screen for ovarian cancer, and will be recommended for all women over the age of 35. OvaDx uses approximately 100 proteomic biomarkers in a microarray format to identify molecular beacons of ovarian cancer that accumulate in the bloodstream as a result of the body's natural immune response to developing ovarian tumors. Arrayit's microarray test, which detects both early and late stage ovarian cancer, leverages the company's patented microarray platform and distinguished 13-year track record as a microarray technology leader. OvaDx will be marketed and sold by the company's subsidiary Arrayit Diagnostics, Inc., in Houston, Texas.
"We are pleased to retain DOCRO for FDA approval of OvaDx," stated Arrayit CEO Rene Schena. "DOCRO brings a breadth and depth of experience that matches the importance of bringing the first early stage pre-symptomatic ovarian cancer screening test to market."
About Arrayit Corporation
Arrayit Corporation, headquartered in Sunnyvale, California, leads and empowers 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. Arrayit now offers over 650 products to a customer base of more than 10,000 clinics and research facilities, and more than 5,000 laboratories worldwide, including most every major university, pharmaceutical and biotech company, major agricultural and chemical company, government agency, national research foundation and many private sector enterprises. Please visit http://www.arrayit.com for more information.
About Arrayit Diagnostics, Inc.
Houston-based Arrayit Diagnostics, Inc., a majority-owned subsidiary of Arrayit Corporation, is actively engaged in developing and commercializing a series of proprietary microarray-based diagnostic tests that provide for early detection of cancers, neurodegenerative diseases and other chronic and severe disease states.
About DOCRO, Inc.
DOCRO, founded in 1996 and located in Seymour, Connecticut, is a full service research organization specializing in the design and conduct of clinical trials of in vitro diagnostic products to gain marketing clearance or approval from the U.S. Food and Drug Administration. DOCRO offers complete clinical trial management, FDA resources and technology development.
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/A for the fiscal year ended December 31, 2008 and Form 10-Q/A for the fiscal first quarter ended March 31, 2009, Form 10-Q/A for the fiscal second quarter ended June 30, 2009 and Form 10-Q for the fiscal third quarter ended September 30, 2009.