FDA

An Oregon Health Authority committee issued a draft guidance to not cover NGS testing for solid tumors, which advocacy groups say will limit access to Medicaid beneficiaries.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

The agency's regulatory plan differs in key areas from a draft of the Diagnostic Accuracy and Innovation Act that had shored up lab industry support.

Clinical research has shown that the assay exhibited 100 percent sensitivity compared to culture-based testing methods, Hologic said.

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.