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.

The Wall Street Journal reports that National Institutes of Health Director Francis Collins' response to contamination concerns at the agency might have delayed care.

The final revision of the Common Rule doesn't include the proposed change requiring consent for leftover biospecimens.

The first Reproducibility Project: Cancer Biology papers show mixed results.

In Nature this week: mobile phone-based targeted DNA sequencing, and more.