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Vermillion Eyeing Return to Nasdaq, Launches OVA1 Ovarian Cancer Test with Quest Dx

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This story originally ran on March 10 and has been updated to include additional information on Medicare's decision to cover OVA1.

Vermillion this week launched its OVA1 triage ovarian cancer test as part of its effort to return to commercial viability.

OVA1 is being made available through Quest Diagnostics, who is launching the test along with Vermillion. Medicare is also covering the test, Vermillion said.

This week, Vermillion also announced the reformation of its scientific advisory board and told ProteoMonitor that it is working to get listed again on the Nasdaq exchange.

This week's developments are the latest steps by Vermillion as it emerges from Chapter 11 reorganization [See PM 01/08/10]. The launch of OVA1 is a milestone moment for Vermillion in its turnaround bid as well as in its transformation from its original business as a proteomics technology firm to a diagnostics company.

OVA1, comprising five protein biomarkers, is the first proteomic in vitro diagnostic multivariate index assay to be cleared by the US Food and Drug Administration [See PM 09/17/09].

OVA1 is aimed at enabling physicians to assess, prior to surgery, the likelihood that a woman's ovarian mass is malignant. According a joint statement from Vermillion and Quest, an analysis performed by third parties on behalf of Quest estimated that ovarian masses affect 1 million women in the US and lead to as many as 300,000 ovarian mass surgeries.

Clinical practice guidelines recommend patients with ovarian cancer to be under the care of a gynecological surgeon, but current pre-clinical tests for ovarian masses, such as CT scans and ultrasound, can be inconclusive about the evidence of cancer, Quest and Vermillion said. About one-third of initial surgeries for ovarian cancer are performed by gynecological surgeons.

In a prospective clinical study, OVA1, combined with pre-surgical clinical and radiological assessments used by non-gynecologic oncologists, detected 92 percent of malignant ovarian masses compared to 72 percent without OVA1. Also, 14 of the 20 women in the trial whose cancer was missed by pre-surgical clinical and radiological assessments would have been identified as having malignant masses if OVA1 results had been evaluated before their surgeries, Vermillion and Quest said.

Medicare is covering the test, Vermillion said, and Highmark Medicare services is the contractor with the Centers for Medicare and Medicaid Services that will process Medicare claims for OVA1.

"This decision by Highmark Medicare Services reaffirms our belief that OVA1 can provide meaningful clinical information to assist physicians in identifying women with a high likelihood of having malignancy prior to planned surgery," Vermillion CEO Gail Page said in a statement.

According to the National Cancer Institute, an estimated 21,550 new cases of ovarian cancer were diagnosed in 2009. Nearly 15,000 women died from the disease last year.

The OVA1 launch caps off a wild year for the company that saw a dramatic reversal of its fortunes. Just a year ago, the company was on the verge of filing for Chapter 11 protection as its finances dwindled and it could find no avenues for additional funding needed to keep its doors open [See PM 04/02/09].

Since getting FDA clearance for the test, Vermillion's share price has shot up dramatically. It rose from $0.05 at the close of market on Sept. 10 — the day before the FDA gave OVA1 the thumbs-up — to $1.29 at the close of Sept. 11, the day clearance was given.

At the close of the market on March 10, Vermillion shares were trading at $31.

In late 2008 Vermillion's stock was delisted from the Nasdaq because it did not meet a number of listing requirements and began trading on the Pink Sheets.

In an e-mail to ProteoMonitor this week, a Vermillion spokeswoman said that the company is "working to get relisted [on the Nasdaq] and to do so will need to complete 2008 and 2009 audits."

The company is in the process of getting the audits done, she said, and "will file as soon as reasonably possible."

Vermillion this week also said that it has re-established a scientific advisory board. The members are Robert Bast; Daniel Chan; Walter Carney; John Cooke; and Gordon Whiteley.

Bast, a professor of cancer research at the University of Texas MD Anderson Cancer Center is best known as the discoverer of the ovarian cancer 125 monoclonal antibody that led to the production of the CA125 radioimmunoassay.

Chan is a professor of pathology, oncology, urology, and radiology and the director of the Center for Biomarker Discovery at the Johns Hopkins University School of Medicine. Both he and Bast were previously members of Vermillion's SAB before it filed for Chapter 11.

Carney is head of the Oncogene Science organization, which functions as a center of oncology excellence for Siemens Healthcare Diagnostics. He also invented the circulating HER2/neu protein test.

Cooke is a professor and associate director of the Stanford Cardiovascular Institute at the Stanford University School of Medicine, while Whiteley is director of the antibody characterization laboratory for SAIC-Frederick.

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