Congressional action needed to optimize regulation of genomic tests

27 mayo 2015

Latest generation genomic testing offers a chance for improvements in patient care, disease prevention and healthcare cost-effectiveness. A new report recommends that Congress incentivize development of massive data systems that doctors and regulators will need to make these tests safe and effective for patients. Existing regulatory oversight should be bolstered with ongoing postmarket data collection to study tests after they are in use and resolve lingering questions about health impacts of as-yet-poorly-understood genetic variants, experts argue.