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 agency has been gathering stakeholder input on how to regulate sequencing-based infectious disease diagnostics, including targeted and metagenomic approaches.

An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.

Policy's Effect

An FDA official says a policy limiting the hiring of foreign researchers is affecting the agency's ability to draw new employees, Stat News reports.

The firm reported a 69 percent increase in product sales, driven by a 102 percent jump in cartridge sales and jump in research revenues.  

The move is precipitated by CMS's decision to grant national coverage to NGS companion diagnostics when they're approved by the FDA.

The approval includes the use of either tumor tissue or plasma and follows previous approvals with Genentech's Tarceva (erlotinib) and AstraZeneca's Tagrisso (osimertinib).

The US National Institutes of Health and the Food and Drug Administration have proposed changing gene therapy oversight, the Associated Press reports.

At his FDA Law Blog, Jeffrey Gibbs discusses FDA's technical assistance for the draft Diagnostic Accuracy and Innovation Act.

Varied Opinions

The Union of Concerned Scientists surveyed US government scientists about Trump Administration policies and more, Science reports.

Pages

The New York Times reports that the US Department of Defense has implemented about half the recommendations made to improve safe handling of dangerous agents.

An Australian-led team has generated a draft genome assembly of the invasive cane toad in hopes it will help in population control, the Sydney Morning Herald reports.

In PLOS this week: approach for teasing out archaic introgression in human genomes, immune transcription features in HCV infection, and more.

Stat News reports that Maryland is promoting itself to the biotech industry with a mobile billboard.