Arrayit Corporation (ARYC)

[Alyssa]

But Mr. Mike, you should not forget that ARYC ultimately decided NOT to go the 510(k) way for OvaDx, but rather decided to seek a Class III Premarket Approval (PMA), which is a higher standard and more demanding than a 510(k) and a different process. To accomplish this, they hired an expert firm out of Connecticut. We do not know how far along they are in the process, but approval must be very close since ARYC announced this in mid 2010.

"...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 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."

http://www.arrayit.com/Arrayit_Corporation_ARYC_Corpo/Microarray_Media_-_Press/Arrayit_Corporation_Announces_/arrayit_corporation_announces_premarket_approval_-pma-_submissio.html