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.
"We have carefully considered the technical and regulatory issues with respect to OvaDx and have decided that a PMA submission, though more demanding that a 510(k0K, is the most appropriate pathway to market for our ovarian cancer screening test," said Arrayit CEO and Chairman Rene Schena in a statement.
The FDA regulates in vitro diagnostic devices under three classes. Class I devices are considered the least risky and subjected to pre-market 510(k) notification, while Class II devices are considered to be riskier than Class I products and are subject to pre-market 510(k) approval. Class III devices are considered the riskiest and subject to PMA.
The OvaDx test is based on Arrayits proprietary microarray platform to identify about 100 protein biomarkers in serum and detect ovarian cancer as early as five years in advance of any symptoms, the company said.
Arrayit did not say when it would be filing its application with the FDA.