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NEW YORK – Chugai Pharmaceutical, a subsidiary of Roche, announced today that Japan's Ministry of Health, Labour, and Welfare has granted additional approval of Foundation Medicine's FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for entrectinib (Roche's Rozlytrek), marketed in Japan by Chugai.

The drug is for treating neurotrophic tyrosine receptor kinase fusion-positive solid tumors. It is a ROS1/TRK inhibitor and has been approved for treating adult and pediatric patients with NTRK fusion-positive advanced and recurrent solid tumors.

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Oct
09
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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.