LDTs - G2 Intelligence

VALID and VITAL Are Back in Play—and This Time One of Them Might Actually Pass

VALID and VITAL Are Back in Play—and This Time One of Them Might Actually Pass

by Glenn S. Demby | Jul 20, 2021 | Blog, FDA-nir, Legislation-nir, Must read, News, Open Content

The COVID-19 pandemic exposed the truth of something the lab industry has known and publicly stated repeatedly for over a decade: The FDA is ill-equipped to regulate Laboratory Developed Tests (LDTs) and allowing it to continue to do so, at least under its current...

First Ever Approval of COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

First Ever Approval of COVID-19 Blood Spot Self-Collection & Molecular Test Pooling

by Glenn S. Demby | Jul 11, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet, FDA-lir, Laboratory Industry Report, Must read

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Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices

Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices

by Glenn S. Demby | Jul 1, 2021 | Articles, CMS-lir, Essential, FDA-lir, Laboratory Industry Report

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VALID and VITAL Are Back in Play—and This Time One of Them Might Actually Pass

Newly Reintroduced VITAL Act Would Strip Agency of LDT Regulatory Authority

by Glenn S. Demby | Jun 14, 2021 | Articles, Clinical Diagnostics Insider, Diagnostic Testing and Emerging Technologies, FDA-dtet

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Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices

Manufacturers Wait Anxiously for CMS Decision on Automatic Medicare Coverage of MCIT Breakthrough Devices

by Glenn S. Demby | Jun 8, 2021 | Articles, CMS-lir, Essential, FDA-lir, Laboratory Industry Report, LDTs-lir, Must read

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