FDA

The Center for Genomic Interpretation and NSGC want payors to cover confirmatory testing for patients with positive results from 23andMe's FDA-cleared test.

Quickly, Quickly

Gene therapies could qualify for a faster US Food and Drug Administration approval process, according to Stat News.

NPR reports that the US House of Representatives has passed a bill to enable terminally ill patients access to experimental drugs.

Despite the astronomical costs, it may prove challenging to reverse course and discontinue Zika testing according to a commentary article accompanying a NEJM study.

The firm's LeukoStrat CDx FLT3 Mutation Assay detects internal tandem duplications and tyrosine kinase domain mutations in patients with acute myeloid leukemia.

The agency asked Reps. Bucshon and DeGette to consider the precertification program idea as they work on refining the draft of the Diagnostic Accuracy and Innovation Act.

The Dublin-based company also aims to raise up to €5 million this year to support additions to its R&D and sales and marketing teams.

The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.

The ResistancePlus MG Positive Control kit was listed with the FDA for sale in the US, where it will be sold through SpeeDx's US entity.

The test is designed to identify a tumor's tissue of origin by assessing 2,000 individual genes and covers 15 common tumor types.

Pages

A University of California, Los Angeles-led team has found turning off the CCR5 gene could improve recovery after a stroke, according to Scientific American.

South Dakota lawmakers are to weigh a bill aimed at teaching the strengths and weaknesses of scientific concepts, the Associated Press and KEVN-Black Hills Fox report.

In Science this week: the synthetic genetic system hachimoji, and more.

Thermo Fisher Scientific says it will no longer sell machines in China's Xinjiang region, according to the Wall Street Journal.