Policy & Legislation
News on government policy and legislation impacting life science and diagnostics.
The law would require state-regulated health insurance plans to cover biomarker testing for patients when recommended by clinical practice guidelines.
While patients can benefit greatly from non-trial access to investigational therapies, policy experts are calling for more guardrails around those programs.
The draft guidance provides suggestions for randomized and single-arm trials to support accelerated approval and confirmatory studies of cancer drugs.
White House Report Outlines Goals to Advance Genomic Research, Precision Therapy Development
The report, on goals for biotechnology and biomanufacturing in the US, suggests areas of investment including multiomics, cell therapies, gene editing, and microbial genome sequencing.
ACMG Statement Says Preimplantation Polygenic Risk Testing 'Not Appropriate for Clinical Use' Yet
Overall, the organization remains skeptical of the clinical implementation of PRS testing, pointing to limitations of the tests and a lack of evidence for their clinical utility.