The discussion draft includes the regulatory proposals, including precertification, the FDA provided to legislators in a technical assistance document.
The National Society of Genetic Counselors has garnered bipartisan support for H.R. 7083 by emphasizing healthcare savings from using counselors to drive appropriate test use.
H.R. 7083, developed in collaboration with the National Society of Genetic Counselors, seeks to improve Medicare payment for genetic counselors.
The bipartisan bill passed both the House and Senate by large margins and increases the NIH's budget by 5.4 percent over its fiscal 2018 funding level.
Seventeen organizations don't support the Diagnostic Accuracy and Innovation Act as written and would like lawmakers to advance a CLIA-centric framework.
The Canadian government is asking for the constitutionality of the country's new anti-genetic discrimination law to be assessed, Bloomberg BNA reports.
ACLA said the goal of the delay is to redefine "applicable laboratories" and give labs and CMS more time to collect data that will inform market-based pricing.
The US House of Representatives has passed the latest version of the 21st Century Cures Act.
The DTWG proposal for regulating in vitro clinical tests has made it into draft legislation but it still needs support from key stakeholders in the life sciences field.
The discussion document contains many proposals for modernizing the way drugs and medical devices are advanced, but legislators are conspicuously silent on diagnostic regulations, specifically LDTs.
Australia will not be regulating gene editing of plants, animals, and human cell lines as long as no new genetic material is incorporated, reports Nature News.
The Washington Post reports that the US Department of Agriculture told its researchers to label peer-reviewed articles as "preliminary" work.
Researchers have sequenced the genomes of both the coast redwood and the giant sequoia, according to the San Francisco Chronicle.
In PNAS this week: study of epigenetic patterns in mammalian eggs, clonal expansion patterns in CD8+ T cells, and more.