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The approval is based on results of the PROfound trial, which included men with mutations in BRCA1/2 or ATM, and 12 other genes associated with the HRR pathway.
The oral MET inhibitor, marketed as Tabrecta, is for patients whose tumors have a mutation that leads to MET exon 14 skipping as detected by a Foundation Medicine test.
The FDA approved the drug based on data on response rate but continued approval is contingent on the results of a randomized study showing a PFS and OS advantage.
With TMB as a CDx, the drug will be available to more patients as a salvage option, but doctors will still need to consider the complex biomarker amid evolving research.
Foundation Medicine's liquid biopsy test will be used in the third stage of SCRUM-Japan, which focuses on advanced cancer patientsin Japan and other Asian countries.
Paired tumor/germline analysis is not routinely done in cancer care, but some labs are starting to report incidental germline findings alongside patient's tumor profiles.
A federal court said Guardant CEO Helmy Eltoukhy deleted emails pertaining to two similar cases, but it remains unclear whether he did so intentionally.
Foundation Medicine's ctDNA assay was able to subclassify patients into higher and lower recurrence risk groups with CTCs providing an additional boost.
The FDA approved FoundationOne CDx as a companion diagnostic for alpelisib in combination with fulvestrant to treat certain PIK3CA-mutated breast cancers.