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.
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.
Researchers are refining a tool to predict a woman's risk of developing breast cancer, according to the Guardian.
In PNAS this week: gypsy moth genome sequenced, phylogenomic analysis of Polyneopterans, and more.
CNN reports that people's genes tend to have a greater influence on their risk of developing disease than their environment, but it varies by phenotype.