Arrayit Pursuing PMA from FDA for OvaDx | GenomeWeb

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – Microarray firm Arrayit today said that it will be seeking pre-market approval by the US Food and Drug Administration for its OvaDx ovarian cancer test.

In a statement, the Sunnyvale, Calif., firm said that though the PMA process is more stringent than the 510(k) route, it believes it can receive Class III PMA approval for the test.

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