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Pathway Genomics Remains In FDA Crosshairs For Genetic Testing Service

An untitled letter from FDA targets Pathway Genomics' recent launch of a cancer screening assay that FDA says is being marketed directly to consumers without proper FDA review.

Genetics testing company Pathway Genomics, which saw its retail marketing plans blocked five years ago, has again drawn FDA attention. The agency moved this week to notify the company that its new cancer screening kit lacks needed FDA approval for what the agency views as a high-risk test.

An untitled letter dated Sept. 21 targets Pathway’s CancerIntercept Detect, a blood test that the firm says can screen for up to 10 different cancers in high-risk populations

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