IVD DNA Test For Cancer Receives New Regulatory Classification

The approval for Invitae’s cancer risk diagnostic test opens the door for more tests of its kind.

Person in a lab pipettes in background, there are samples in tubes in the foreground
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Invitae’s Common Hereditary Cancers panel is a first of its kind for the diagnostics industry.

On 29 September, the diagnostic received de novo authorization with special controls from the US Food and Drug Administration, opening the door for similar products to be cleared through...

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