NEW YORK (GenomeWeb) – Vermillion said this week that it has received a CE mark for its Overa ovarian cancer test, clearing the test — a second-generation of its OVA1 proteomic test — for sale in the European Union.
The extent to which the company will pursue international sales of Overa remains to be seen, though.
In a statement issued this week, Vermillion President and CEO Valerie Palmieri said the company is "actively identifying global partnerships." Vermillion also had several international arrangements for the sale of OVA1, however, to date, none have resulted in actual sales of the test.
For instance, in 2011, the company signed a deal with Pronto Diagnostics to distribute OVA1 in Israel and the Palestinian territories. David Jansen, Vermillion's vice-president of marketing, told GenomeWeb this week that that deal yielded no sales of the test. The agreement does not cover Overa, he said.
Also in 2011, Vermillion and Quest signed an agreement under which Quest would offer OVA1 in India through its facility in Gurgaon, but that deal ended with the recent restructuring of the sales agreement, Jansen said.
In 2010, Vermillion obtained a CE mark for OVA1, however, the company never established any sales agreements for the test in the EU.
Like OVA1, Overa is intended for triaging patients with ovarian adnexal masses as part of preoperative evaluations to determine the likelihood that a mass is cancerous.
According to Vermillion, the new test offers several improvements over the existing OVA1 test. Most significant are the improvements in specificity and positive predictive value, which are, respectively, 28 percent and 29 percent higher in Overa than in OVA1.
The specificity and PPV improvements are significant in that low specificity was cited by some critics of the original OVA1 as an issue that could prevent gynecologists from ordering the test.
The primary rationale underlying OVA1 and Overa is that by helping determine if a mass is likely benign or likely cancerous it can help gynecologists decide whether they can undertake a surgery to remove the mass themselves or if they should refer their patient to a gynecological oncologist. The test's low specificity, however, could lead to high numbers of false positives, meaning gynecologists would be referring to oncologists patients who, in reality, had benign masses that the gynecologists could have removed themselves.
The hope is that Overa's improved specificity will help counter this objection. However, in an interview this week with GenomeWeb, Andrew Berchuck, director of gynecologic oncology at Duke University School of Medicine, noted one trend in the field that could work against the company's aims.
Even in the case of benign masses, "the bar is lower than ever for [gynecologists] referring patients to an oncologist," he said, noting that the rise of minimally invasive surgery as a method for removing such masses means that a higher level of surgical skill is typically required.
"Ob/Gyns are not as skilled surgeons as gynecological oncologists, and when you switch from open surgery to minimally invasive surgery, such as laproscopic or robotic surgery, it takes even more skills," he said.
A lower threshold for referring cases to a gynecological oncologist somewhat undercuts the rationale for a test like Overa, which aims to give gynecologists more information for making such a decision.
More generally, said Berchuck, while he understands Vermillion's rationale for working to improve specificity in the Overa test, the improved performance does not change his opinion of the test. In a 2011 interview with GenomeWeb, he said he felt the original OVA1 test did not offer enough information beyond standard ovarian cancer marker CA125 to justify its cost. This week he said he felt the same regarding Overa.
"I felt then and feel now that it is a much more expensive test than CA125 and it doesn't really add that much," he said.
Vermillion submitted Overa to the US Food and Drug Administration for 510(k) clearance in March of this year and aims to launch the test commercially by the end of the year.