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Vermillion Submits 510(k) for OVA2; Aims to Launch Test in Q3


NEW YORK (GenomeWeb) – Vermillion said this week that it has made a 510(k) submission to the US Food and Drug Administration for clearance of its second-generation ovarian cancer test OVA2.

Vermillion President and CEO Valerie Palmieri made the announcement on a conference call discussing the company's Q4 2014 earnings, noting that it made the submission on March 6 and hoped to receive clearance and launch the test in late Q3 of this year.

The OVA2 test replaces two of the five OVA1 protein markers with new biomarkers and, according to Vermillion Senior Vice President and CSO Donald Munroe, offers improved specificity and positive predictive value.

OVA1's relatively low specificity has in the past raised concerns among some physicians, as it likely leads to patients being passed on unnecessarily to gynecological oncologists. This, they have said, could make gynecologists wary of using the test for fear of losing their patients based on inaccurate results.

During the earnings call, Munroe said Vermillion had completed double-blinded validation of OVA2 in collaboration with three external clinical sites. He added that the company planned to present the results of this validation study at conferences and submit them to peer-reviewed journals with publication targeted for the second half of 2015.

OVA2's development also involved porting the test from the legacy instruments used for OVA1 to the Roche Cobas 6000 platform, roughly 10,000 of which have been placed worldwide, Munroe noted.

Vermillion is counting on launch of OVA2 and a revamping of its sales approach to reverse its commercial fortunes. Despite a number of management changes and sales reboots over the last several years, OVA1 sales have remained largely flat.

Indeed, in its Q4 and full-year 2014 earnings reported this week, the company posted essentially flat revenues and OVA1 test volumes on a year-over-year basis, despite a sales "relaunch" begun in 2013 and a 2014 sales force expansion.

On this week's earnings call, Palmieri laid out Vermillion's latest sales plan, noting that in late 2014 the company had hired a new sales force, replacing the contract sales force it had hired earlier in 2014, and had completed training this new sales force in Q1 2015.

Palmieri also announced a new sales approach in which the company aimed to focus not only on OB/GYN's, but also gynecological oncologists and hospital systems and networks.

"This multi-channel approach will drive volume in the gynecological oncologist referral base, increased exposure of payers as well as assist in the creation of guidelines within large networks and systems," she said.

Vermillion also plans this year to publish health economic data on OVA1, including a poster this week at the American College of Medical Quality, Palmieri said. It also plans to launch two regional impact studies on OVA1 in the second half of 2015.

Another key to the company's strategy moving forward is the new commercialization and services agreement it recently reached with Quest Diagnostics, ending the prior alliance between the two firms, which Vermillion had sought to terminate.

Under the agreement, Vermillion will pay Quest an undisclosed sum and fees for logistical support services as Vermillion transitions its OVA1 ovarian cancer testing business from Quest to its own subsidiary, Aspira Labs.

Additionally, the two parties have reached a settlement of all claims related to their prior alliance. Under the settlement, Vermillion paid Quest $1.07 million to reconcile disputed charges related to a credit agreement between the two companies.

Vermillion believes the new agreement will be beneficial in that it will give it more control over the sales process, and, ultimately, allow it to keep a greater percentage of test revenues as it transitions to running the tests through Aspira.

Aspira is currently licensed in 39 states, and, Palmieri said, the company expects to obtain licensure in all 50 states in the second half of 2015. Aspira performed 152 OVA1 tests in Q3 2014 and 257 OVA1 tests in Q4 2014.

Vermillion also laid the ground for an international expansion by registering OVA1 in the EU on March 6. Palmieri said the company's "international plan... will begin to show fruit in 2016."