CDC Group Finds No Evidence to Support Use of LabCorp's ColoSure Test in General Risk Population
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.
Tight Budgets Defund Key CDC Effort, but Director Will Retain Focus on Public Health Genomics
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.