BiotechnologyU.S. FDA approves Foundation Medicine’s FoundationOne®CDx as a companion diagnostic for Roche’s Rozlytrek® (entrectinib)
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (U.S. FDA) has approved Foundation Medicine’s FoundationOne®CDx as a companion diagnostic (CDx) for Roche’s Rozlytrek® (entrectinib). FoundationOne CDx is a comprehensive genomic profiling (CGP) pan-tumour tissue biopsy test that assesses an individual’s cancer to identify the unique molecular ‘fingerprint’ of the tumour. It is the first and only U.S. FDA-approved CDx to identify patients with ROS1 fusion-positive non-small cell...