Policy & Legislation
News on government policy and legislation impacting life science and diagnostics.
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.
Absent Resolution on FDA's LDT Oversight in 2022, Some Payors Began Advancing Their Own Requirements
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After the VALID Act didn't pass, it's uncertain how the FDA will proceed, though some payors aren't waiting for the status quo to change and asking labs to submit additional validation data on cancer tests.
President Biden Signs Spending Bill, Boosting NIH, CDC, and FDA Budgets
The bill includes funding for medical device cybersecurity, health disparity research, and antibiotic resistance research, among other initiatives.
Genomics Firms Tackle Carbon Emissions, Face Obstacles to Net-Zero Goals From Suppliers, Shipping
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Proposed SEC rules about emissions reporting are spurring companies to act, but carbon reductions could be offset by growth and lack of control over the supply chain.