(RTTNews) - Roche (RHHBY), on Thursday, announced that the United States Food and Drug Administration has approved Foundation Medicine's FoundationOne CDx as a companion diagnostic or CDx for Roche's Rozlytrek or entrectinib.
FoundationOne CDx is a comprehensive genomic profiling or CGP pan-tumour tissue biopsy test that assesses an individual's cancer to identify the unique molecular 'fingerprint' of the tumour.
The company stated that it is the first and only U.S. FDA-approved CDx to identify patients with ROS1 fusion-positive non-small cell lung cancer or NSCLC, or patients with NTRK fusion-positive cancers, for whom treatment with Rozlytrek may be appropriate.
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