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FDA Gives Guardant Health IDE Approval for Clinical Trial of Merck KGaA Cancer Drug

NEW YORK (360Dx) – The US Food and Drug Administration has given Guardant Health an investigational device exemption approval to provide genomic testing for a cancer drug currently under development.

Guardant is providing testing for a clinical trial of the small molecule, c-Met kinase inhibitor called tepotinib being developed by Merck KGaA, which operates as EMD Serono in the US and Canada. Merck is using Guardant's liquid biopsy test Guardant360 CDx to identify patients with Met exon 14 skipping alterations who may qualify for the ongoing Phase II tepotinib trial.

Earlier this year, Guardant announced partnerships with several drug firms, including Merck KGaA, to develop a 500-plus gene liquid biopsy panel for use in clinical trials and cancer drug immunotherapy development.