Policy & Legislation

News on government policy and legislation impacting life science and diagnostics.

Sep 7, 2022

WHO Expands Prequalification Assessment for TB Molecular Test Developers

Aug 25, 2022

Senate Bill Proposes Bringing Back Patents on Genes
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Aug 25, 2022

VALID Act Divides Dx World as IVD Biz Welcomes Consistency, Flexibility While Labs Fear Red Tape
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Aug 19, 2022

Lab Orgs Push Back Against CMS Plan to Let Nurses Perform High-Complexity Testing
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Aug 16, 2022

Tuberville Amendment Aims to Address VALID Concerns, but Draws Little Apparent Interest
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Jul 24, 2022

VALID Act Likely to Slow Test Development, but Impact Will Vary Across Lab Industry
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Jul 6, 2022

Newly Introduced Legislation Aims to Address Lab Industry's PAMA Complaints
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Jun 22, 2022

Congress Introduces Legislation to Update PAMA Lab Reporting Requirements

Jun 16, 2022

VALID Act Passes Out of Senate HELP Committee, But Potential Cracks in Support Appear
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May 26, 2022

As IVDR Date of Application Arrives in Europe, Challenges to Implementation Remain
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May 24, 2022

ACMG Review Finds NIPS Accurately Detects Common Trisomies in General-Risk Pregnancies

May 18, 2022

California, Other States to Cover Rapid WGS of Newborns Under Medicaid, but Questions of Access Loom
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May 3, 2022

Labs Worry End of HRSA Funding Could Impact Access to COVID-19 Testing for Uninsured
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Apr 14, 2022

As UK Adjusts to 'Living with COVID,' Some Lament Suspension of Free Lateral Flow Testing
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Mar 25, 2022

ACMG Survey Finds Laboratory Geneticists Have Concerns Over Proposed Changes to LDT Regulation

Mar 23, 2022

Industry Flexibility, Government Support Needed to Address Long-Term COVID-19 Testing Needs
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Mar 16, 2022

FDA Control of LDTs Looms as Momentum Builds for VALID Act
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Mar 16, 2022

Cue Health Gets Authorization to Offer At-Home COVID-19 Test in Canada

Feb 28, 2022

Legislators Introduce Bill Seeking to Raise PGx Awareness, Adoption
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Feb 20, 2022

Federal Government Ramps COVID-19 Test Supply, But Interest, Not Access, Limiting K-12 Testing
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