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Women's Health - First Blood Test for Ovarian Cancer Wins FDA Approval | Health News

Posted Nov 02 2009 10:01pm 1 Comment
Women's Health - First Blood Test for Ovarian Cancer Wins FDA Approval | Health News

On Friday, September 11, the FDA announced their approval of the first laboratory test that, prior to exploratory surgery or biopsy, can indicate the likelihood of ovarian cancer, even if radiological tests fail to indicate malignancy. The announcement comes at a fitting time—during September—the month recently designated by President Obama as National Ovarian Cancer Awareness Month.

The test, called OVA1, was developed by California-based Vermillion Inc., in conjunction with their partner, Quest Diagnostics, and with researchers at The Johns Hopkins University in Baltimore. OVA1 uses a blood sample to check levels of five proteins that change due to ovarian cancer, and then simplifies the results into a score between zero and 10, indicating whether the pelvic mass is benign or malignant. The test is intended only for women 18 and older who are already selected for surgery because of their pelvic mass. Interpreting the test result requires knowledge of whether the woman is pre- or post-menopausal.

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The OVA1 test costs just under $700.  But it is becoming the gold-standard for ovarian cancer identification prior to surgery or when a mass is found on exam.  It may eventually become mainstream as a "screening test".  It is now available via Direct Access Testing (DAT) on online sites such as eStatLabs.    for more information.
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