Clinical trial for OVA1 blood test showing promising results for detecting ovarian cancer

July 31, 2012 by Bob Yirka, Medical Xpress weblog

(Medical Xpress) -- Researchers at Vermillion, a medical diagnostics company have announced that clinical trials for its OVA1® blood test diagnostic tool have shown promising results. The tool, part of Vermillion’s OVA500 program is aimed at developing tests that provide doctors and patients with better information regarding whether ovarian growth’s (tumors) are cancerous or simply benign cysts, prior to surgery.

OVA1 was first approved for back in 2009, giving a hint as to why such tests tend to cost so much once they are finally approved. Lumps or tumors in ovaries are generally first discovered by manual manipulation of the pelvis by a doctor; unfortunately, the discovery doesn’t allow them to fully understand their nature without resorting to a biopsy. A that could reveal the type of tumor would save time, money and emotional stress for patients. If approved for use by doctors, OVA1 would allow a medical professional to take a small blood sample at the time that any unusual changes in the ovary are noticed. Testing involves using software analysis of the sample using proprietary algorithms developed by Vermillion, it performs calculations on five immunoassays and produces a number that indicates the likelihood of a tumor of being malignant. In the trials, which are conducted independent of Vermillion, 494 patients were involved in the most recent trial (a thousand have participated overall) with the focus on women already diagnosed with still in the early stages and those that are premenopausal. The premenopausal group was included in the study because few women in that group get that type of cancer but a lot of them get benign cysts.

Overall it appears OVA1 did quite well, finding a sensitivity of 94% for the premenopausal patients and 91% for those who were known to have early stage cancers. The percentages indicate the ability of the blood test to detect cancer (or rule it out) in the people tested. In addition, false positives were rated as very low (just 2%).

The announcement caused shares of Vermillion stock to rise significantly, but more importantly, suggests that the blood test works as advertised which means that someday soon, women may perhaps be spared the torment of undergoing a surgical procedure and then worse perhaps, waiting two or more days for the results, when all they actually have is a benign cyst.

Explore further: FDA clears biomarker test for ovarian cancer

More information: Press release

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