FDA Warning on Ovarian Cancer Screening Test -- Is It Enough?

Maurie Markman, MD


September 26, 2016

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Hello. I'm Dr Maurie Markman from Cancer Treatment Centers of America in Philadelphia. I want to comment briefly on a new US Food and Drug Administration (FDA) warning regarding claims by a company that they have a test based on a CA 125 algorithm that can detect ovarian cancer early.[1] The claims are, as noted by the FDA, false. There is currently no evidence that any CA 125 testing strategy, or other type of strategy, can detect ovarian cancer early.

There is currently no evidence that any CA 125 testing strategy, or other type of strategy, can detect ovarian cancer early.

Clearly, we all would hope that such a test would be available, but the fact is that today we simply do not have such testing. The FDA is concerned, very appropriately, that false claims are being made that one can detect ovarian cancer early. Their concern, again very appropriately, is that women may have symptoms suggestive of ovarian cancer but then undergo this testing and it doesn't suggest ovarian cancer. They may then delay seeking medical intervention. In addition, there is the opposite concern: that unnecessary surgery could be performed in the case of a false [positive] test.

There are established strategies that have been developed to test the validity of screening strategies, and this particular test has simply not fulfilled that requirement. It remains somewhat bewildering to me that commercial companies—in this case, based in Great Britain—can be permitted to offer testing that has clearly not been shown to be validated and cannot be stopped by the FDA. One must ask the question: Why does the FDA not have the authority to not only warn the public but to actually stop such companies from selling products that are of no value? One might add that if these companies didn't listen to the FDA, then perhaps the next step might be criminal prosecution.

The public deserves to be aware of tests that [make] claims that are false, and in this case, this company that is claiming it has a test to detect ovarian cancer at an early stage is simply not valid, based upon the existing data.

I would encourage you to read the warning of the FDA, which is well founded, and hopefully this company can voluntarily, or be mandated to, stop selling this product that is potentially harmful. I thank you for your attention.


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