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A consortium convened by Friends of Cancer Research has made progress in quantifying sources of TMB assay discordance and created a new test-alignment software tool.
Tasso said academic medical institutions, government agencies, cancer centers, and pharma organizations are already using its blood collection devices.
The company expects to garner clearance for its platform in the US first for Lynch syndrome as it builds additional evidence for an immunotherapy application.
The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
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 agency reviewed data showing that HRD-positive patients on the olaparib/bevacizumab combination had median progression-free survival of 37.2 months.
The company's PD-L1 IHC 22C3 pharmDx identifies patients with non-small cell lung cancer who qualify for first-line monotherapy with pembrolizumab.
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.
Myriad has partnered with Japanese firm SRL, a subsidiary of Miraca Group, to commercialize its BRACAnalysis Diagnostic System in Japan.
The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.