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.
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.
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.
The company announced during its Q4 earnings call that it had acquired Paradigm Diagnostics and Viomics to fill out its expertise in cancer diagnostics.
The company has multiple companion diagnostics partnerships in the works, with new tests on the way in 2020, and new plans for next-generation sequencing.
Recent studies question the clinical utility of tumor mutational burden as a biomarker for immuno-oncology response, and the FDA clearance includes no therapeutic indications.
In a survey conducted by an association working group, 40 percent of respondents said they are already offering TMB, with most others planning to do the same within the year.
The company said it has seen progress in efforts to get FDA approval for its tissue and liquid biopsy tests as data continues to accumulate for pan-cancer utility.
