Some pharmacogenomic DTC tests that aim to assess a person's response to particular medicines may end up available only through a doctor's prescription, says New Scientist's Peter Aldhous. As FDA moves toward regulating the DTC genetic testing industry, the question of whether pharmacogenomic tests in particular should be regulated is "emerging as a flashpoint," Aldhous says. Last week, an FDA panel convened to make recommendations on the issue; members of the panel generally agreed that several types of tests should be available only by prescription, including, Aldhous says, "pre-symptomatic tests for serious conditions, such as cancer, and pharmacogenetic tests." DTC firm 23andMe says that while no one should alter their medical routines without first consulting a doctor, physicians shouldn't be the "gatekeepers" of genetic information, Aldhous adds.
A DTC 'Flashpoint'
Mar 18, 2011