The Food and Drug Administration issued two draft guidances Thursday that aim to provide a flexible, efficient approach for regulating individualized genomic testing, in accordance with President Barack Obama's Precision Medicine Initiative.
Next-generation sequencing involves scanning a person's DNA to detect genomic variations that could determine whether an individual is at risk for a variety of diseases. The information may also help physicians choose the optimal treatment option.
"Precision care is only as good as the tests that guide diagnosis and treatment," said Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health at the FDA. "The FDA's job is to ensure that doctors and patients can depend upon the accuracy, reliability and clinical validity of these tests,"
The first draft guidance provides recommendations for designing, developing and validating next-generation sequencing tests for rare hereditary diseases.
The second draft guidance outlines a suggested approach for how test developers can use clinical evidence from public genome databases to support clinical claims for their tests and conduct accurate clinical interpretation of genomic test results.
There will be a 90-day period for the public to comment on the draft guidances before they are finalized.
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