Roche's ROS1+ cancer drug gets FDA greenlight for Foundation Medicine's companion diagnostic
More than four years after Roche bought Ignyta, acquiring a drug — entrectinib — that scored FDA approval about 18 months later, Roche now has a companion diagnostic to pair with that drug and expand treatment options.
Roche said in a statement Thursday that the FDA approved a companion diagnostic from Foundation Medicine for entrectinib, which is currently being marketed as Rozlytrek. The diagnostic, called simply FoundationOne CDx, is essentially a genomic profiling tissue biopsy test. According to Roche, it can identify the unique “fingerprint” of a solid tumor.
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