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


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.

The ROMA test, which is marketed by Fujirebio Diagnostics and developed in collaboration with researchers at Women & Infants Hospital of Rhode Island, could prove a less expensive, more accurate alternative to currently available protein-biomarker based ovarian cancer diagnostics, particularly Vermillion's OVA1.

The ROMA diagnostic "will be used in a very similar manner" to OVA1, Richard Moore, a gynecological oncologist at Women & Infants and leader of the research team that developed the test, told ProteoMonitor. He noted that, while the two tests have roughly equivalent sensitivity, the ROMA diagnostic has demonstrated considerably higher specificity than OVA1. This is especially significant given that OVA1's relatively low specificity has been cited as a potential impediment to its adoption by physicians.

In a clinical trial detailed in a paper published in the August edition of Obstetrics & Gynecology, Moore's team found that the ROMA test had a sensitivity of 93.8 percent and a specificity of 74.9 percent in a study of 472 women. By comparison, OVA1 demonstrated sensitivity of 94 percent and specificity of 35 percent in a pair of Obstetrics & Gynecology papers published on the test in May (PM 05/13/2011).

In an interview prior to the publication of these papers, Laura Havrilesky, a gynecological oncologist at Duke University, told ProteoMonitor that OVA1's low specificity could prove problematic.

"If you're a gynecologist and you're sending every single patient who comes in the door with a problem out to a specialist, that's perhaps not financially good and also perhaps not really in the best interest of all your patients," she said. "Looking at those [specificity] numbers, if you were sitting in your general OB-GYN practice, they might be a little concerning – 'A lot of my benign cases are going to go out the door because I'm doing this test on everybody.'"

During Vermillion's first-quarter earnings call in May, CEO Gail Page made remarks that suggested the company is aware of this concern. Discussing the development of Vermillion's next-generation ovarian cancer diagnostic OVA2, she cited initial data presented by its collaborators at Johns Hopkins University describing biomarkers that can improve on the clinical specificity of CA125, noting that "improving on clinical specificity will be a key feature in future tests for the diagnoses of ovarian malignancy."

Beyond specificity, the ROMA test also compares favorably to OVA1 in terms of price, Moore said. Vermillion has licensed OVA1 exclusively to Quest Diagnostics, which charges around $600 for the test. By contrast, "running HE4 and CA125 is going to cost anywhere from $60 to $128," he said. "So that's a huge difference."

Indeed, in a May interview, Andrew Berchuck, director of gynecologic oncology at Duke University Medical Center and former president of the Society of Gynecologic Oncologists, told ProteoMonitor that the relatively high cost of OVA1 is one of his main issues with the test.

OVA1 "costs $650 compared to $50 for a CA125 [test]," he said. "And if one wants to add a second marker that complements CA125, they can order an HE4 test for $50. So the OVA1 test is not a great value."

Peter Levine, CEO of Correlogic, which has its own protein biomarker test for ovarian cancer under development, told ProteoMonitor that he thought in the near-term this price discrepancy would likely have the largest impact with regard to patients paying out of pocket for such a tests.

"To the extent that patients might have to pay for it themselves, it might have a big impact," he said. "Vermillion has been very successful and very clever at obtaining reimbursement, so I don't know where this might lead down the road with insurers. But near-term it would certainly have an impact if someone had to actually pay for it out of pocket."

Both CA125 and HE4 are well-established ovarian cancer markers, with a variety of companies including Quest and Abbot offering FDA-approved assays for the proteins. That means the ROMA test "can be run in any lab – any hospital lab, any commercial lab," Moore said.

The rights for the use of HE4 to monitor ovarian cancer risk are held by Fujirebio through a license from the Women & Infants researchers, he said, adding that the patents for the ROMA test itself are shared by the two parties.

In 2008, the FDA cleared the HE4 assay for use in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer.

OVA1 measures CA-125 as well as four other proteins — beta-2 microglobulin, transferrin, apolipoprotein A1, and transthyretin — but does not measure HE4.

The trial detailed in the August Obstetrics & Gynecology paper was the second multi-center trial for the diagnostic, Moore said. The initial trial, he said, "was mainly carried out in gynecological oncology offices and centers," which resulted in a patient cohort that was "considered to be at a higher risk for ovarian cancer."

"We went to FDA [with that trial], and they came back and said what they wanted was a trial in low-risk populations," he said. "So we did the second multi-center trial that was [using] patients evaluated by non-oncology specialists. What we showed in that [trial] was that the sensitivity and specificity didn't change [when used in a low-risk population]. So it was a valid test to use" in that population.

Molika Ashford contributed reporting for this story.

Have topics you'd like to see covered in ProteoMonitor? Contact the editor at abonislawski [at] genomeweb [.] com.