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NMPA

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 company said that the DxA 5000 reduces the number of required manual steps and can shorten the preanalytical processing time by up to 73 percent.

For 2019, the firm's total revenues from commercial operations, licensing, and collaborations are expected to grow to more than €3 million.

The clearance by the Chinese NMPA means the instrument can be used as a clinical diagnostic tool in hospitals, laboratories, and clinics in China.

The kit is approved for the qualitative detection of BRCA1 and BRCA2 mutations in patients with different cancer types including breast cancer.

The company received Chinese regulatory approval for a lung cancer assay last year and plans to seek approval for a liquid biopsy test this year.

The firms will jointly invest in establishing a joint venture company in China, and Autobio has also invested €10 million in Mobidiag.

Agena has an ongoing partnership with Guangzhou-based DaRui to develop MassArray-based diagnostics for cancer and inherited diseases for the Chinese market.

The firm's next-generation sequencing diagnostic test analyzes tumor samples from multiple genomic mutations that are targeted by therapies for non-small cell lung cancer.

MGI received medical device certification clearance for its MGISEQ-200 and MGISEQ-2000 instruments.

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