Saturday, August 30, 2008

Ova not so sure?

From the New York Times article "Cancer Test for Women Raises Hope, and Concern":

“You’ve got industry trying to capitalize on fear,” said Dr. Andrew Berchuck, director of gynecologic oncology at Duke University and the immediate past president of the society. “We’d all love to see a screening test for ovarian cancer,” he added, “but OvaSure is very premature.”

OvaSure’s debut also raises questions about whether greater regulation is needed to assure the validity of a trove of sophisticated new diagnostic tests that are entering the market and are being used as the basis for important treatment decisions. OvaSure did not go through review by the Food and Drug Administration because the agency generally has not regulated tests developed and performed by a single laboratory, as opposed to test kits that are sold to laboratories, hospitals and doctors.
Think sensitivity and specificity, and positive and negative predictive values, folks!! Click here to access the NYT article. If you'd like to learn more about sensitivity and specificity, etc., check out the BMJ article "Understanding sensitivity and specificity with the right side of the brain" published in 2003 (sub. req).

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