News on companion diagnostics and drug/test co-development.
The immunohistochemistry-based CDx will operate on the Roche BenchMark ULTRA instrument.
The quantitative immunoassay measures the concentration of a novel antibiotic, plazomicin (Zemdri), using the automated clinical chemistry analyzer Beckman Coulter AU 680.
The CDx, which will include the detection of activating FGFR2 fusions, is expected to be incorporated into Foundation Medicine's FDA-approved FoundationOne CDx assay.
The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.
The CDx would guide use of Novartis' BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women with HR+/HER2- breast cancer.
