FDA Recklessly Approves DNA Test as a Substitute For PAP Smear

Marie McCulla writing for the Philadelphia Inquirer at Philly.com in her post on May 11, 2014 reports on actions the Food and Drug Administration took last month approving a particular DNA test as an alternative to Pap Smears.  Now medical societies of family practitioners, internists and gynecologist will have to consider whether and how to incorporate the FDA action.

First, it is important to know that the particular DNA test which was approved is called the “Cobas Test” and is manufactured by Roche.  The test accurately identifies 14 of the 140 strains of human papilloma virus.  HPV16 and HPV18 cause about 70% of cervical cancer.

Richard T. Hopley, M.D., staff pathologist at Path Advantage Associated, wrote in opposition to the FDA’s application for approval.  Dr. Hopley has written that he regards the portion of the DNA surveyed by the Cobas HPV test as a feature that in fact makes the test unreliable particularly with reference to advanced disease.

In addition Dr. Hopley points to two well-known articles in the medical literature suggesting superior sensitivity for the diagnosis of cervical cancer than is provided by HPV testing alone.

The Pap smear is far from perfect but it has made an enormous contribution to salvaging the lives of tens of thousands of women who have benefited from the earlier diagnosis of their disease at a time before invasive cancer has occurred.

Such a dramatic change as suggested by the FDA needlessly places lives at risk because of malignant transformation and infection which may also be identified by a Pap smear.

Hopefully, the societies’ of cytopathology, internal medicine, family practice and gynecology will look before this leap is taken.

All articles in this blog are the collaborative effort of attorneys Jerry Meyers, Brendan Lupetin, and Gregory Unatin.

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