February 8th, 2012
Posted on 24. Aug, 2010 by PublicWire in Medical
(ARYC.OB) Arrayit Corporation Chooses Premarket Approval Pathway For OvaDX Screening Test
(PublicWire.com News Release)Arrayit Corporation (OTCBB:ARYC), 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.
(ARYC.OB) Arrayit Corporation Chooses Premarket Approval Pathway For OvaDX Screening Test
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.”
ARYC.OB, ARYC.OTCBB, OTCBB:ARYC, ARYC
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