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Companion Diagnostics

News on companion diagnostics and drug/test co-development.

Thermo Fisher has also applied to the Japanese Ministry of Health, Labor, and Welfare to expand the use of the Oncomine Dx Target test in Japan.

Burning Rock also said it will continue to develop companion diagnostics-related products based on next-generation sequencing technology.

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 results from two cohorts of a Phase II, single-arm trial in which EZH2-mutated patients had an overall response rate of 69 percent.

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.