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To Regulate or Not?

The argument by the US Food and Drug Administration that it needs to oversee laboratory-developed tests is generally favored by Democrats, but has left Republicans divided, the New York Times says.

As GenomeWeb's Turna Ray reported last week, both FDA and the Centers for Medicare & Medicaid Services argued before Congress that FDA needed to take on a larger role in evaluating the safety and efficacy of such LDTs.

In a series of case studies, FDA investigators found a number of issues with some LDTs, including with genetic ones. According to Ray, FDA noted that a false-positive result from a non-invasive cell-free DNA prenatal test had led to an unnecessary abortion and said that an ovarian cancer screening test that wasn't well validated could have led patients to undergo unnecessary surgery to remove their ovaries. 

"Doctors and patients rely on these tests to make well-informed health care decisions," Jeffrey Shuren, the director of the Center for Devices and Radiological Health at FDA, tells the Times. "If they get inaccurate results, they can make the wrong decisions, and people get hurt as a result."

A spokesperson for Genomic Health, the maker of one of the tests mentioned in the report, tells the Times that "a wealth of evidence has supported use of our test to help guide chemotherapy treatment decisions in more than 500,000 breast cancer patients to date."

The question of whether to extend FDA oversight to LDTs poses a dilemma for small-government Republicans, the Times notes.

"This is a tough area for conservative Republicans who think that government is too big and costs too much," Rep. John Shimkus (R-Ill.) tells the Times. He adds that he'd consider legislation as "the volume and complexity of these tests have grown exponentially," and federal regulation may be necessary to make sure the tests are accurate.

However, Rep. Michael Burgess (R-Texas), who is a physician, says the proposals "could stifle medical innovation and open the door to federal regulation of the practice of medicine."