FDA

The test MRSA and MSSA directly from blood culture samples in about one hour, compared to between 48 and 72 hours with other methods, the company said. 

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

Shutdown and the FDA

According to Stat News, the partial government shutdown in the US could soon affect the ability of the Food and Drug Administration to review new drugs.

Data from the GUIDED study will be central to commercial payor discussions, a Medicare LCD reconsideration request, and eventually expansion into the primary care market.

Sequencing has helped identify where an E. coli outbreak may have originated, the Atlanta Journal-Constitution reports.

Closed, Again

The partial federal government shutdown in the US affects a number of science agencies, ScienceInsider reports.

The test is the second of three panels intended to detect pathogens that cause the bloodstream infections that can lead to sepsis.

New drugs, tests, and policies suggest steady and continued future growth in the space, though public awareness of personalized medicine continues to lag.

The firm had also applied for marketing clearance for its gram negative and fungal pathogen panels in October.

The test is now approved as a CDx for advanced ovarian cancer patients considering Lynparza as a first-line maintenance treatment.

Pages

Reuters reports that UK researchers are using gene-editing tools to develop flu-resistant chickens.

Nature calls for genomics to become part of the World Health Organization's cholera surveillance approach.

Vox explores a proposal to institute a lottery system to award grant funds.

In Genome Biology this week: gut microbiome study of individuals from Tanzania and Botswana, sixth version of the Network of Cancer Genes database, and more.