By Ben Glickman
The Food and Drug Administration gave de novo marketing authorization to a diagnostic test that can help detect genes associated with elevated risk of developing cancers.
The FDA said that the test, called the Invitae Common Hereditary Cancers Panel, was an in vitro diagnostic test designed to identify 47 genes which are linked to an elevated risk of cancer.
The de novo premarket review is a regulatory pathway through the FDA for low- to moderate-risk new medical devices.
The FDA said the approval would allow subsequent tests of the same type to go through a potentially quicker and cheaper pre-market process.
Invitae tested over 9,000 samples and found an accuracy greater than or equal to 99%.
Write to Ben Glickman at ben.glickman@wsj.com
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