Correlogic Systems this week announced the launch of a two-year validation study for its OvaCheck proteomics pattern-based ovarian cancer test in high-risk women. The test is being conducted in collaboration with North Shore-Long Island Jewish Research Institute in Huntington, NY, and is supported by three grass roots funding organizations with political support from a US Congressman (see PM 6-18-04).
The company and NS-LIJ aim to produce enough supportive statistical evidence for the test to justify releasing it on the market for high-risk women following the completion of the study, according to John Lovecchio, NS-LIJ’s chief of gynecologic oncology, and a principal investigator on the study.
“This is a significant clinical trial for high-risk individuals, and assuming that statistically, these data are verified, I don’t see any reason why it shouldn’t be used on the market for patients at high risk, immediately,” Lovecchio told ProteoMonitor. He added that if the high risk study proves sufficiently promising, “we’re going to translate the validation study … into screening the generalized population, looking at asymptomatic, low-risk women. That’s ultimately the goal.”
Correlogic has said in the past that the test should be used initially for only high-risk women, since problems with false positives would come more into play in a general population screen (see PM 5-28-04), and that view is shared by most OvaCheck supporters (see PM 6-18-04). Lovecchio said that if the test goes on the market for high-risk or low-risk women, it should be used in conjunction with traditional methods such as CA125 testing, transvaginal sonograms, and pelvic examinations, “at least initially.”
Correlogic’s CEO, Peter Levine, said in an e-mail to ProteoMonitor that the new study is “part of Correlogic’s ongoing validation of OvaCheck,” and that NS-LIJ represents one of a variety of sources that Correlogic is using for validation samples.
Levine has said in the past that Correlogic, LabCorp, and Quest are all in the process of conducting extensive validation studies on OvaCheck, but he confirmed this week that LabCorp and Quest will only be involved in this study “indirectly, in that when the test is available commercially, these samples will have contributed to the validation.”
Rep. Steve Israel (D-NY) first organized a meeting between Correlogic and NS-LIJ two years ago, after introducing a resolution, which passed the US House of Representatives, that further research on the test and insurance coverage for using it should be supported by the government. Israel took an interest in OvaCheck after reading the 2002 Lancet article that introduced the pattern recognition approach, according to Correlogic and NS-LIJ. Levine and Israel together suggested the current validation study to NS-LIJ, Christina Verni, spokeswoman for NS-LIJ, said. Israel also was instrumental in rounding up funders for the study, which include the Lynne Cohen Foundation for Ovarian Cancer Research, Row for a Cure, and the Sonia L. Totino Gynecologic Cancer Research Fund, Lovecchio said.
Lovecchio said that the validation study will look at several different groups of high-risk women, who will be recruited to participate through local media and hospital advertising venues. One group will consist of women with a personal history of breast or ovarian cancer; another will include women with a familial inheritance pattern but who do not necessarily have the BRCA1 or BRCA2 gene; and a third group will include women who do have the BRCA1 or BRCA2 gene. In addition, the study will include samples from any women “going into the operating room with an ovarian mass, either high risk or low risk” — meaning women who are diagnosed with ovarian cancer, as well as those who have a benign mass. The group that presents with ovarian cancer will be analyzed for recurrence and progression of the disease, and those with benign masses will be used as benign controls to assess the test’s ability to distinguish between cancerous and non-cancerous masses.
The study will be blinded to both doctor and patient, Lovecchio said. After Lovecchio and his partners collect the samples, they will be shipped to Correlogic’s laboratory, where Correlogic will analyze them using its pattern recognition software. The study is expected to last about two years, at which point, “I think then we can break out some of the data [for a paper] once it becomes validated — and I think it will be, statistically — and then use the OvaCheck test in conjunction with our traditional methodologies of diagnosing ovarian cancer … to see how OvaCheck will fit in into the diagnostic [tools] that we already possess,” Lovecchio said.
Lovecchio said that once this study is complete, he didn’t see any reason why the FDA should not support the use of OvaCheck. The FDA put a halt to plans to release the test on the market early this year as a home brew, when it sent letters to Correlogic, LabCorp, and Quest warning them that the test may be subject to FDA oversight (see PM 2-27-04, 3-5-04, 3-12-04).
“If you set out to prove statistically that this particular test has high utility in high risk patients, and if it’s proven statistically, I don’t see why the FDA would thwart that kind of promotion,” he said. Until that time, however, “I would endorse as a member of the [Society of Gynecologic Oncologists] the SGO’s position that this test right here, right now, should not be entertained even remotely as a screening device,” he said.