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The firm can now market the drug to Chinese patients with early-stage HER2-positive breast cancer.
The company has permission from US and Chinese regulators to launch human studies of its anti-Claudin 18.2 monoclonal antibody following positive preclinical studies.
This is the second approval for tislelizumab following the drug's initial approval in classical Hodgkin's lymphoma last year.
The high-throughput S2000 sequencer is the second instrument Genetron Health has received NMPA approval for, following the S5 benchtop instrument last year.
Labs in China can now use the Cobas EGFR Mutation Test v2 with either tissue or plasma samples as a CDx for three Roche oncology drugs in NSCLC patients.
The kit is approved for the qualitative detection of BRCA1 and BRCA2 mutations in patients with different cancer types including breast cancer.