In a prelude to overhauling its regulatory oversight of genetic diagnostic testing, the U.S. Food and Drug Administration will convene a public meeting next week to gather input from test makers and others.
The event reflects a turning point in genetic testing, a cornerstone of personalized medicine. Once mainly the domain of rare diseases, scientists have discovered a growing number of genetic variations linked to both the risk of more common disease and patients' response to drugs. The number of genetic diagnostic tests has expanded rapidly, and tests have become increasingly complex, making it more challenging to interpret and act on the results.
"We don't think physicians are going to be able to interpret the results; they are relying on the labs that make them," says Alberto Gutierrez, director of the Office of In Vitro Diagnostic Device Evaluation and Safety at the FDA. "So we think a third party should assess these devices."
From Technology Review
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