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Genetics & Genomics Regulatory News & FDA Approvals

The latest regulatory news and FDA approvals.

The clearance covers tests made by the firm's joint venture for manufacturing, CoSara Diagnostics, in its facility in Ranoli, India.

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 company also said that it expects a clearance decision from US regulators in the near term on a lower respiratory tract infection test that runs on its Unyvero system.

The company's antibiotic-induced hearing loss test will be used to screen babies for a genetic mutation that can cause deafness when given certain antibiotics.

Doctors can now order the test to identify breast cancer patients with BRCA1/2 mutations who may be eligible for surgery or targeted therapy.

Researchers are sampling the wild relatives of modern crops to try to preserve genetic diversity, NPR reports.

MIT's Search for Extraterrestrial Genomes is developing sequencing tools to use to try to detect whether there is any life on Mars, Quartz reports.

Undark reports on a bill introduced this year to the US House of Representatives to strengthen scientific integrity.

In Genome Research this week: post-zygotic mutations in diabetes development, single-cell RNA sequencing study of aging, and more.