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Guardant Health, Roche’s Foundation Medicine Receive FDA Companion Diagnostic Nods

 
• By Marion Webb

Roche’s Foundation Medicine still leads Guardant Health in terms of total companion-diagnostic US FDA approvals as both companies announced new PMA supplements.

Liquid biopsy

Two rivals in the liquid biopsy space, Guardant Health and Roche's Foundation Medicine unit, received companion-diagnostic PMA supplements from the US Food and Drug Administration.

Guardant Health announced on 28 May that the FDA approved its Guardant360 CDx test as the first and only liquid biopsy companion diagnostic for identifying patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the KRASG12C mutation and may benefit from Amgen, Inc.’s Lumakras (sotorasib) FDA-approved KRAS G12C inhibitor

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