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FDA Approves Vermillion's Ovarian Cancer Test; Launch Slated for Q4

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This story, which originally ran on Sept. 11, has been updated with additional comments and background.

By Tony Fong

Vermillion, the beleaguered company currently seeking Chapter 11 bankruptcy protection, received clearance for its ovarian cancer diagnostic last week from the US Food and Drug Administration.

For a company that has been struggling to stay afloat for at least the past three years, the decision from the FDA amounted to a Hail Mary pass that brought Vermillion back into the game, although the company still faces considerable hurdles ahead.

Developed in collaboration with Quest Diagnostics, the test, called OVA1, is based on five biomarkers and will become available in the fourth quarter, the two companies said in a press release. Quest has exclusive rights to market and sell the test to clinical reference laboratories in the US for three years, while Vermillion can sell the test to other markets.

OVA1 is an in vitro diagnostic multivariate index assay and the first FDA-cleared laboratory test that can indicate the likelihood of ovarian cancer with high sensitivity before a biopsy or exploratory surgery, the two firms said, adding that it can diagnose cancer even in instances where radiological tests fail to indicate malignancy.

Citing statistics from the American Cancer Society, Vermillion and Quest said that approximately 21,600 new cases of ovarian cancer are expected to be diagnosed in the US in 2009, and about 14,600 women are expected to die from the disease.

In an interview with ProteoMonitor, Gail Page, executive chairperson of Vermillion's board, said that with the approval the priority is for the two firms to prepare for the launch of the test as quickly as possible. That includes working with "industry experts" to assess the "value proposition" for the OVA1 test to establish a price for the test and reimbursement levels from insurers.

"Then based on this approval, [Vermillion's board] will be looking at all the strategic alternatives that now become available to the company," she said. Along with preparing for the launch of OVA1, Vermillion is preparing its Chapter 11 reorganization plan for the bankruptcy court in Delaware. "And then upon that, we will look at potentially raising money," Page said. "We will look at partnerships; we will certainly entertain any offers from the industry."

The initial launch will be in the US, though Vermillion will be looking to bring the test to Europe and Japan eventually.

Page declined to provide a market estimate for the test until the launch.

In a statement, Jon Cohen, chief medical officer and senior vice president of Quest, said that while surgery is usually associated with favorable outcomes, doctors often don't know if a pelvic mass is benign or malignant until a patient undergoes surgery. OVA1, he said, could help doctors make that evaluation before surgery. Quest is the only company offering FDA-cleared tests for ovarian cancer in the pre- and post-surgical settings, the company said.

In a statement, Jeffrey Shuren, acting director for the FDA's Center for Devices and Radiologic Health, said, "Tests such as OVA1 personalize and improve public health by providing patients and health care providers with more information to support medical decisions that impact survival rates and reduce surgical complications."

The test is intended for women ages 18 and older who are already selected for surgery because of their pelvic mass. It is not intended for use as a screening device for ovarian cancer or as a definitive diagnosis for the disease, the FDA said.

In reaching its decision, the agency reviewed a study of 516 patients, including 269 evaluated by non-gynecological oncologists, comparing results from OVA1 with biopsy results. When combined with pre-surgical information, such as radiography, OVA1 was able to identify additional patients who could benefit from an oncology referral who were not identified using only pre-surgical information, the FDA said.

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Vermillion filed its 510(k) application with the FDA for the test in June 2008 [See PM 06/26/08], four years after it began developing an ovarian cancer test based on a set of protein biomarkers it licensed from Johns Hopkins University. OVA1 is serum based and comprises five biomarkers — transthyretin; apoliprotein A-1; beta2-microglobulin; transferrin; and cancer antigen 125 — and uses an algorithm to come up with a numerical score indicating a patient's likelihood of malignancy.

The test is crucial to the survival of Vermillion, at least in the near term. Once a technology development firm, Vermillion, formerly called Ciphergen, shifted its full attention to the diagnostics market after selling its SELDI platform and associated businesses to Bio-Rad Laboratories in 2006 [See PM 08/17/06].

Since then, the company has focused on three disease areas in its diagnostic development pipeline. Late in 2007, Vermillion launched a lab-based test for thrombotic thrombocytopenic purpura, co-developed with Ohio State University. Vermillion licenses the assay to OSU. Additionally, the company is developing a test for peripheral artery disease with Stanford University, and has other tests directed at ovarian cancer.

Its greatest priority, however, has been getting regulatory approval for the OVA1 test. The sale of the SELDI business left the company with virtually no product revenue source, and in documents filed with the US Securities Exchange Commission, it has repeatedly said that it may not have any revenues pending FDA approval of the test.

The TTP test had generated some revenues, but it was not nearly enough to sustain Vermillion, and in recent financial reports filed with bankruptcy court, the firm has posted no sales. During the summer, Vermillion asked the court to extend the deadline for submission of its reorganization plan until it had learned of its FDA application.

In doing so, Vermillion said that while it had made "substantial progress managing its business" since its Chapter 11 filing, its success will ultimately "hinge on the FDA's approval of OVA1. … With such a significant contingency standing between [Vermillion] and the successful formulation and implementation of a plan, [Vermillion] submits that seeking approval of a plan and disclosure statement without FDA approval of OVA1 would be premature."

The court ultimately agreed to push back the deadline to Nov. 25. It also delayed the deadline by which Vermillion can solicit and obtain acceptances of its reorganization plan to Jan. 24, 2010 [See PM 08/06/09].

FDA's approval of the test last week "gives the company a whole new breath of fresh air," Page said. When Vermillion made the decision to leave the technology development space to become a pure diagnostics firm, it felt that its biomarkers "had true potential and this demonstrates that potential," she added.

FDA's approval for OVA1 comes as Vermillion's cash reserves dry up. It ended July with $175,666 in cash and cash equivalents. Vermillion had total assets of $9.6 million and total liabilities of $33.6 million.

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