OvaSure Renounced by FDA

LabCorp, the manufacturer of a blood test for early detection of ovarian cancer, has agreed to pull the test known as OvaSure off the market. LabCorp expedited availability of the test by an FDA regulation exemption and began selling OvaSure in June 2008. The company claimed the exemption for the product via a government stipulation that allows tests developed and marketed by a single company to bypass federal approval. The FDA, however, claims OvaSure is not eligible for the exemption because it was developed at Yale, not within the company. This claim surfaced after public concern was expressed regarding the accuracy of the test. The test measures the level of six proteins produced either by cancer cells themselves or by the body in response to the presence of cancer. These measurements are then used to calculate the probability of the presence of malignant cancer. The method has shown to have a 0.6-1% false positive result, causing unnecessary surgical ovary removal for patients without cancer. Developers suggest limiting availability to high risk populations and requiring a second test for positive results in order to decrease unnecessary surgeries. High risk populations include women with BRCA1 or BRCA2 genetic mutations and those with a family history of breast or ovarian cancer. The test could also be combined with imaging procedures to verify diagnosis. OvaSure does not effectively detect recurrent cancer.

The agreement raises questions within the industry over efeective regulatory policy. The FDA recognizes the conflict between readily available and efficient diagnostic tools. The Administration began revising the current policy for complex testing procedures like OvaSure two years ago, but has yet to finalize a procedure. Competing companies, such as Vermillion which submitted OVA1 as a similar test for approval in June, believe all products should be held to the same standards. Companies in the private sector can benefit form university research only if they are willing to comply with federal regulation. Even if the procedure is not 100% accurate, it's imporant to have such diagnostic tools. There are other methods available to support or disprove OvaSure test results, but without the test many cases may go undiagnosed. As of Friday, however, OvaSure will not be available to doctors and at risk patients. They will have to wait for goverment approval for this and similar tests, which could be the difference between life and death for some.

Medical News Today Article:
http://www.medicalnewstoday.com/articles/127260.php
New York Times Article:
http://www.nytimes.com/2008/08/26/health/26ovar.html?pagewanted=1&_r=1

~Angie Burrer
Section501