Every year, nearly 21,650 women are diagnosed with ovarian cancer. Of that number, nearly 21,650 women die from the disease. Ovarian cancer is said to be three times more lethal than breast cancer.

But if the disease is detected at an early stage, it is said to increase dramatically. If ovarian cancer is diagnosed and treated at the localized stage, the 5-year survival rate is 92%; unfortunately, only 19% of all cases are found at the localized stage.

Laboratory Corporation of America Holdings (LabCorp; Burlington, North Carolina) says that its new product, OvaSure, will be able to assess the presence of early stage ovarian cancer in high-risk women. The company reported that the device — a blood test that uses six biomarkers to determine the presence of cancer in the body — is available for commercial use.

"LabCorp is offering the OvaSure test as a laboratory-developed test, which is regulated by CLIA and CMS," Eric Lindbolm, a spokesman for LabCorp told Medical Device Daily via e-mail "LabCorp does plan, however, to continue to seek guidance on the regulatory status of our offering from the FDA."

The test identifies six biomarkers in its detection of ovarian cancer; MIF, Prolactin, CA-125, Osteopontin, Leptin and IGF-II.

The problem in detecting ovarian cancer is that it does not show specific symptoms that allow its identification during the early stages. Usually a diagnosis is made only after progression to later stages, at which point the spread of the cancer limits effective treatment.

The report goes on to say that the potential implication of early detection of ovarian cancer on patient outcome is shown by the differential survival rates of women diagnosed at different stages of disease progression. The 10-year survival rate is nearly 90% when the disease is localized to the ovaries at the time of diagnosis and drops to 20% when the disease has spread to distant sites at the time of diagnosis.

According to a Phase II clinical trial, the test was shown to discriminate between disease-free women and ovarian cancer patients (stage I-IV) with high specificity (99.4%) and sensitivity (95.3%).

"There were 362 healthy women and 156 newly diagnosed ovarian cancer women (stages I-IV) in the Phase II trial performed by Yale University (New Haven, Connecticut)," Lindblom said. "Information on Phase III has not yet been published, and consequently is not available. Yale University is currently completing various reviews and we expect they will publish the results by the end of the year."

The company signed an exclusive agreement with Yale in early 2006, according to Lindblom.

"LabCorp is pleased to offer for high-risk women the OvaSure test to enhance the potential of detecting and treating ovarian cancer in its early or localized stage when the likelihood of survival is greatest," Myla Lai-Goldman, MD, executive VP and chief medical officer of LabCorp, said in a news release. "OvaSure is a significant addition to LabCorp's family of proteomic tests, and a major component of [our] strategy to bring the latest in diagnostic technology to women's healthcare."

According to the company, each test will cost about $225, and results will be available within four business days. The test is 99.4% accurate for positives (sensitivity) and 95.3% accurate for negatives (specificity).

This is the second such application geared toward ovarian cancer that has garnered media attention in recent weeks.

Initial results of a new pilot study show that four symptoms, combined with the CA125 blood test, can greatly improve the early detection of ovarian cancer by 20%, Fred Hutchinson Cancer Research Center (Seattle) and published last month online in Cancer (Medical Device Daily, June 25, 2008).

Research has found that when used alone, its CA125 ovarian-cancer blood test and a simple four-question, symptom-screening questionnaire asking if abdominal or pelvic pain, difficulty eating or feeling full quickly and abdominal bloating are present, each detect about 60% of women with early-stage ovarian cancer and 80% of those with late-stage disease.

The study found that when used together, the questionnaire and blood test may boost early detection rates to more than 80% and late-stage detection rates to more than 95%.

The research center is gearing up for a larger clinical study to further prove efficacy of the test.

LabCorp is a diagnostics technologies company with a specialty in genomic testing. It has more than 26,000 employees and has products such as clinical assays ranging from routine blood analyses to HIV and genomic testing. The company has annual revenues of $4.1 billion.