Welcome to the Coalition for Innovative Lab Testing

Safeguarding the Availability of New, Accurate, Reliable, Diagnostic Tests by Resisting Deadly Government Overregulation

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Our response to the FDA’s Proposed Rule to Regulate LDTs

Last year, the VALID Act, which would have created a new regulatory framework for Laboratory-Developed Tests that many lab advocates believed to be overly burdensome, stalled out in Congress. Now, some who continue to push for additional oversight for LDTs beyond current CLIA requirements are looking for the FDA to create new regulations through its rulemaking process.

Learn more about the VALID Act and how it would curtail innovative laboratory testing in the private sector.

Sign our letter to Congress

Did Government regulations hamper the fight against COVID-19 at a critical juncture? In this short video Roger Klein from Arizona State University Law School, explores the harms caused by government regulation of clinical labs at the start of the pandemic.

Watch this video to see The “Original Sin” of the government’s over-regulation of lab tests at the beginning of the pandemic.