Regulatory News, FDA Approvals | GenomeWeb

Regulatory News

The assay has been available outside the US since November and runs on the Liaison MDX benchtop instrument. 

Elizabeth Mansfield, who spearheaded regulations at the agency for precision medicine and next-generation sequencing, will lead regulatory affairs at Illumina-backed Grail.

The firm's ROS1 gene fusion kit was approved as a companion diagnostic for Pfizer's Xalkori.

The company's Barocycler 2320Extreme is now available to the European biopharma market.

The FDA granted Abbott Emergency Use Authorization for the assay in serum, plasma, and urine in November. 

In Science this week: genetic target for urothelial bladder cancer treatment, and more.

At the Conversation, the University of Oxford's Michael Macklay writes that learning genetic risk of disease is a personal decision.

Two dozen scientific organizations have endorsed the March for Science, according to ScienceInsider.

Researchers in Japan describe a chimpanzee with a chromosomal abnormality similar to human Down syndrome, Mashable reports.