Close Menu

FDA

Healthcare providers continue to worry about the impact of 23andMe's health risk reports but there is also growing acceptance of the DTC testing model.

Scott Gottlieb, the commissioner of the US Food and Drug Administration, has announced he will be stepping down from his post next month.

Last year, the Gottlieb-led FDA approved 25 new molecularly-defined drugs and expanded indications compared to 19 in the prior year, and issued a slew of guidelines important for the personalized medicine field. 

A Drug or What?

The FDA has yet to determine if fecal microbiome transplants should be treated like a drug or like a blood transfusion, the New York Times reports.

A report from the Personalized Medicine Coalition finds that more than 40 percent of new drugs approved in the US in 2018 were personalized medicines.

The assay is designed to detect ribosomal RNA from four clinically relevant Babesia species and runs on the company's Procleix Panther system.

Is It Useful?

The New York Times warns in an editorial that 23andMe health risk tests may not provide useful information.

Direct-to-consumer genetic testing firm 23andMe has a newly cleared colorectal cancer risk test.

The clearance enables 23andMe to report on the two most common variations in the MUTYH gene influencing MAP, which increases risk of CRC development.

Pages

University of Idaho researchers model the scientific discovery process to examine the link between reproducibility and scientific truth.

A bill passed by a US House of Representatives appropriations subcommittee would give scientific agencies including the National Science Foundation boosts in funding.

Relocating USDA agencies outside of Washington, DC, may make them less effective, critics of the move tell NPR.

In PLOS this week: genes that help Borrelia burgdorferi survive in ticks, CiliaCarta collection of about 1,000 suspected cilia genes, and more.