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Arrayit Corporation Announces Premarket Approval (PMA) Submission Strategy for OvaDx®
PMA Pathway Chosen to Maximize Value of Pre-Symptomatic Ovarian Cancer Screening Test
Press Release Source: Arrayit Corporation On Monday August 23, 2010, 8:00 am EDT
SUNNYVALE, Calif., Aug. 23, 2010 (GLOBE NEWSWIRE) -- Arrayit Corporation (OTCBB:ARYC - News), a leader in life sciences and healthcare technology, announces today that the company has chosen the Premarket Approval (PMA) pathway for its OvaDx® Pre-Symptomatic Ovarian Cancer Screening Test. While the standard for a PMA is higher than for a 510(k), the company believes that a PMA OvaDx® submission can achieve a Class III PMA approval, the most stringent approval level granted by the FDA for in vitro diagnostic devices.
Arrayit OvaDx® employs the company's patented and proprietary microarray platform to identify the presence of approximately 100 protein biomarkers in the serum, allowing the detection of ovarian cancer as early as 5 years in advance of any symptoms. Ovarian cancer is known as the "silent killer" because most patients do not report symptoms until the disease has spread beyond the ovaries to other tissues and organs. Early detection greatly improves treatment options and prognosis, such that long-term survivability of early stage patients is about 90% compared to 10% for late stage patients. Arrayit's OvaDx® test will be marketed and sold upon FDA approval by the company's subsidiary Arrayit Diagnostics, Inc.
Arrayit CEO and Chairman Rene Schena states, "We have carefully considered the technical and regulatory issues with respect to OvaDx® and have decided that a PMA submission, though more demanding than a 510(k), is the most appropriate pathway to market for our ovarian cancer screening test. The Premarket Approval process for OvaDx® will provide a basis for product differentiation in the marketplace, and allow us to maximize shareholder value by gaining the market awareness and market share required to detect ovarian cancer earlier and improve the lives of women afflicted with this serious illness."
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 800 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, including a broad network of international distributors. Please visit www.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, 2010 and Form 10-Q for the fiscal quarters ended March 31, 2010 and June 30, 2010.
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