Diagnostics 2018: Steady Progress And The Big Get Bigger

 
• By Mark Ratner

If the beginning of 2017 was marked by doubts around whether and how the FDA would act with respect to complex diagnostics, we enter 2018 feeling that slow-moving vessel may finally be turning.

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FDA product reviews were the lead story for the year, as Class II device designations emerged for large-panel tumor-profiling assays and direct-to-consumer (DTC) genetic health risk assessment (GHRA) tests.

In early November, the agency put forth its plan to regulate DTC GHRAs, exempting them from premarket review under certain...

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