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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.

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Oct
09
Sponsored by
PerkinElmer

As cases of COVID-19 continued to grow this spring and summer in the US, so too did the number of Emergency Use Authorizations from the FDA for clinical diagnostic tests aimed at detecting current and past infections.