FDA Grants Fujirebio 510(k) Approval for ROMA Ovarian Cancer Dx, Potential Rival to Vermillion's OVA1 | GenomeWeb

This story originally ran on Sept. 6 and has been updated to include comments from a competing firm.

By Adam Bonislawski

The US Food & Drug Administration has granted 510(k) clearance for the use of a combination of blood tests for the proteins HE4 and CA125 with the Risk of Ovarian Malignancy Algorithm, or ROMA, to determine the risk of ovarian cancer in pre- and post-menopausal women with a pelvic mass.

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