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The Genetron Health S5 NGS system is based on the Thermo Fisher Scientific Ion GeneStudio S5 and will be accompanied by Genetron-developed assays.
The approval allows the company to directly market and sell the CTC technology to labs and other institutions to develop and implement IVD tests.
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.
For 2019, the firm's total revenues from commercial operations, licensing, and collaborations are expected to grow to more than €3 million.
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.
Nebula Genomics will be auctioning George Church's genome as a nonfungible token, according to The Scientist.
Anthony Gregg, the outgoing president of the American College of Medical Genetics and Genomics, has resigned after using racially insensitive language.
Facebook has developed an artificial intelligence approach to predict how drugs interact in cells, New Scientist reports.
In PNAS this week: adaptations among high-altitude Mycobacterium tuberculosis, response of multiple myeloma cells to chemotherapy-induced stress, and more.