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Awaiting FDA OK for OVA1 Test, Vermillion Hires Bank to Explore ‘Alternatives’ for Dx

Vermillion this week began preparing for the possible commercialization of its ovarian cancer diagnostic by partnering with an investment bank to explore “strategic alternatives” for the test and holding a conference call to speak with investors about the need for the test.
The bank, ThinkPanmure, a wholly owned US investment banking subsidiary of Panmure Gordon & Co., with six offices in US and India, will help Vermillion identify and evaluate “strategic alternatives intended to enhance the potential” of the test, called OVA1, as well as for its diagnostic for peripheral arterial disease, VASCLIR, Vermillion said in a statement.
The company did not define the alternatives.
Last month, four years after it licensed the test’s five constituent protein biomarkers from Johns Hopkins University, Vermillion submitted the OVA1 test for 501(k) approval [See PM 08/20/04].
For Vermillion, a company that has struggled to build any kind of revenue stream in recent years, the OVA1 test is crucial to its survival, especially since it sold its SELDI instrument business to Bio-Rad Laboratories in 2006 to focus on making and selling diagnostics.
The test, together with VASCLIR and a test launched last year for thrombotic thrombocytopenic purpura, could determine whether Vermillion will be able to keep its doors open.
In 2007, the company reported a loss of $21.3 million on revenues of $44,000, compared to a loss of $22.1 million on revenues of $18.2 million in 2006. During the first quarter of 2008, Vermillion posted receipts of $53,000 up from $21,000 during the year-ago period. Net loss for the quarter dipped to $4.8 million from $6 million a year ago. As of March 31, the company had $8.3 million in cash and cash equivalents.
During this week’s conference call, Gail Page, president and CEO of Vermillion, said the company is “very excited about [the OVA1] and [is] in the process of developing a multi-prong commercialization approach.” She did not elaborate.
The FDA submission followed a clinical test conducted by Vermillion of 514 patients in 27 sites to asses its ability to stratify patients into high- and low-risk categories and determine whether a patient should be referred to specialists for further diagnosis.
According to the US National Cancer Institute, 21,650 new cases of the disease in the US will be diagnosed in 2008. The total number of women with ovarian tumors is not known, said Fred Ueland, principal investigator on Vermillion’s clinical test and an associate professor gynecologic oncology at the University of Kentucky. However, he estimated the number to be between 32 million and 37 million.
While most of the tumors are not malignant or are resolved without surgery, “it’s very important that women with ovarian cancer be referred to a gynecologic oncologist before surgery,” Ueland said. “This is a crucial dilemma for the generalist physician who’s trying to decide who should be referred to a cancer specialist.”

Vermillion is “very excited about [the OVA1] and [is] in the process of developing a multi-prong commercialization approach.”

Determining whether an ovarian mass may be malignant or benign, however, has been part art and part science based on subjective interpretations of physical exams, imaging tests, and laboratory results. There has been, Ueland said, no uniform process to assign risk, and only one of every three women with a malignant tumor is referred to a specialist.
The OVA1 is an index using the five biomarkers to measure the likelihood of malignancy. The test is measured on a scale of one to 10. A score of five or higher indicates the mass is likely to be malignant and the patient should be referred to a gynecologic oncologist.
The test is meant as an adjunctive aid to help primary-care physicians determine whether specialist care and surgery may be necessary, Ueland said.
“OVA1 is not intended for use as an individual screening or diagnostic test for ovarian cancer and should be used only in patients who are candidates for surgery for suspected ovarian malignancy,” he said.
In its clinical test of 514 women, the test achieved an overall sensitivity of 84.8 percent. For epithelial cancer, the most common form of ovarian cancer, sensitivity was 95.8 percent. Overall specificity was 50.1 percent, and OVA1 was able to correctly identify all patients with stage ll through stage lV ovarian cancer, Ueland said. 
The negative predictive value, or its ability to determine the confidence of a negative result, was 88.8 percent.
If approved by the FDA, the OVA1 test would join a very limited number of proteomics-based diagnostics for ovarian cancer that have either been commercialized or are substantially along in the pipeline.
The same week that Vermillion announced its FDA filing, LabCorp went to market with OvaSure, a six-protein-biomarker test for early-stage ovarian cancer in high-risk patients. The company has not filed for FDA approval, and is instead marketing it as a laboratory-developed test under the Clinical Laboratories Improvement Act.
A third company, Correlogic, told ProteoMonitor last month that it is preparing to seek FDA approval for its OvaCheck test for the early detection of epithelial ovarian cancer [See PM 06/26/08].
During Vermillion’s conference call this week, Page declined to put a dollar figure on the market for the OVA1 test, but said it was large.
“There are hundreds of thousands of women … who go through this process every year,” she said.
Vermillion has a lot riding on the test. With barely any revenues, the company has repeatedly issued warnings about its perilous finances in filings with the US Securities and Exchange Commission. It also has had to stave off the threat of having its stock delisted from the Nasdaq exchange [See PM 07/03/08 and 04/03/08].
In March, in a bid to remain on the Nasdaq, Vermillion completed a 1-for-10 reverse stock split to raise its share price.
There are indications, however, that its diagnostics initiatives may soon bear some fruit. Late last year, it licensed its TTP test to co-developer Ohio State University. The test has been launched, and earlier this year, Vermillion said it was being received “favorably” by the market.  During the first quarter of 2008, the TTP test posted sales of $5,000.
In late May the company selected the Colorado Prevention Center to help design a clinical study for its VASCLIR test to support FDA clearance.
In announcing its deal with ThinkPanmure, Page said that, “While reviewing the various alternatives, we will continue to advance our commercialization strategies, namely building marketplace awareness for our women’s health, oncology, and cardiac programs.”
The company did not provide updates on either test this week. Page was not available for further comment.

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