EGAPP | GenomeWeb

EGAPP

Exact Sciences, which licensed the intellectual property behind ColoSure to LabCorp, is developing a next-generation, multi-gene test for colorectal cancer and plans to start clinical trials later this year to support a premarket approval application with the FDA.

Despite a massive budget shortfall, Office of Public Health Genomics Director Muin Khoury will continue to press for government policies and initiatives that promote safe and effective genomic medicine products from a public health perspective.

The "magnitude of net health benefit" from use of eight marketed tests analyzing 58 variants and 29 genes reviewed by the Evaluation of Genomic Applications in Practice and Prevention Working Group is "negligible," the expert panel wrote in a statement.

CDC's GAPPNet has launched several new online resources for gathering information on available genomic technologies, including a searchable database of genomic applications and a new open-access journal that publishes evidence reviews and summary articles on the validity and utility of genetic tests.

Compared to previous personalized bills, HR 5440 includes much more toothy language about FDA regulatory muscle over companion tests. It would also create an Office of Personalized Healthcare to recommend which tests should be regulated and how personalized medicine products should be reimbursed, and form several committees to address translational challenges of personalized medicine.

Speaking at a conference hosted by the Personalized Medicine Coalition, Clancy emphasized that AHRQ is in the business of conducting research, not setting healthcare policy. As such, the agency will continue to investigate personalized medicine interventions to inform the work of the CDC and EGAPP.

The authors of the report recommend conducting randomized trials with "sufficiently large sample sizes and long-term follow-up," in addition to other types of research to determine whether genetic testing in patients with a history of blood clots improves outcomes and whether physicians should alter current treatment practices to adopt genetic testing for the prevention of deep-vein thrombosis.

In Nature this week: genome-wide transcriptome analysis of brain samples from people with autism spectrum disorder, flounder genome, and more.

Researchers used T-cell transfer therapy to target mutation KRAS, according to the New York Times.

The US Senate has passed the 21st Century Cures Act, which would provide a funding boost at NIH while overhauling FDA policies.

Bloomberg reports that President-elect Donald Trump is considering Jim O'Neill for Food and Drug Administration commissioner.