Genetics & Genomics Regulatory News

The latest headlines on diagnostics regulation: FDA, CMS, and international regulatory agencies.

This drug is the first FDA-approved IDH1 inhibitor and will be used to treat adult patients with relapsed or refractory acute myeloid leukemia.

The FDA said that pooled testing of donations using a screening test that it has licensed is a sufficient method for complying with its testing regulations.

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

It is the first of three ePlex molecular multiplex panels for the diagnosis and management of bloodstream infections that can lead to sepsis.

With the new clearance, DiaSorin's test can be run on genital swabs, and all cutaneous and mucocutaneous swab samples, as well as CSF samples.

Sometimes genetic tests give inconclusive results and provide little reassurance to patients, the Associated Press reports.

Vox wonders whether gene-editing crops will be viewed similarly as genetically modified organisms of if people will give them a try.

In Science this week: research regulation and reporting requirement reform, and more.

NPR reports that government and private insurers are being slow to cover recently approved CAR-T cell therapies.