Regulatory News, FDA Approvals | GenomeWeb

Regulatory News

The white paper, while not enforceable, addresses the lab industry's concerns and makes a public health case for FDA oversight of LDTs. 

The firm said that it has completed clinical trials for the Group B Strep assay for the FDA and will start trials for the C. difficile test this month. 

The FDA approved a slew of new drugs with companion and complementary tests, but the most talked about event was its decision to delay final guidance on LDTs.

The PGx firm can offer its RightMed test in 49 states and plans to seek certification in New York this year. 

The kit uses a proprietary non-enzymatic method to prepare intact, single-cell suspensions from tissue in less than 10 minutes.

In PNAS this week: carbapenem resistance in Enterobacteriaceae, selection against educational attainment-linked variants, and more.

Technology Review points out that a new US presidential science advisor hasn't been selected.

Researchers find that blood tests might be able to help determine severity of a concussion, Wired reports.

President-elect Donald Trump considers other candidates for director of the National Institutes of Health, Nature News reports.