1. Medtech Insight
  2. >>Device Area
  3. >>Diagnostics
  4. >>In Vitro Diagnostics

Sen. Alexander Wants To ‘Start From Scratch’ In Regulating Lab-Developed Tests

 
• By Sue Darcey

Senate HELP Committee Chair Lamar Alexander, R-Tenn., suggested he would prefer to “start from scratch” in developing appropriate regulatory controls for laboratory-developed tests, despite a proposed regulatory framework for US FDA for the tests that was more than a decade in the making. That triggered some debate at a Sept. 20 committee hearing.

Scientist

Sen. Lamar Alexander, D-Tenn., said at a Sept. 20 Health, Education, Labor and Pensions Panel hearing that perhaps Congress should create “an entirely new regulatory agency” to handle regulation of laboratory-developed tests (LDTs), in part because US FDA regulation of the tests would be too slow and expensive.

“Sometimes I think starting from scratch is a good idea,” he told Medtech Insight following the hearing. “Actually starting from...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from In Vitro Diagnostics

Arima Genomics’ CEO Sets Sight On Replacing Standard Testing With 3D Genomics Lymphoma Assay

 
• By Marion Webb

Arima Genomics launched its new Aventa Lymphoma test aimed at helping pathologists detect lymphomas missed by standard FISH analysis. Initially positioned as complementary technology, Arima hopes to become the new standard test.

Salient Bio Raises £2.35M For March 2026 Rollout Of At-Home IBD Microbiome Test

 
• By Natasha Barrow

Salient's inflammatory bowel disease test, built on the start-up’s Signal platform, is planned to launch in March 2026. The company leverages rich data from existing wellness tests to develop signatures, focusing on conditions that are often misdiagnosed and disproportionately affect women.

Government-Backed UK Network Enhances Access To Clinical Trials

 
• By Vibha Sharma

The UK government expects that its new nation-wide network will enable companies to set up clinical trials more quickly and expand access to diverse patient populations across the National Health Service.

NextGen Dx Panel Expects Continued Limbo On LDT Regulation

 
• By Elizabeth Orr

A recent conference panel discussed the stagnation in diagnostics regulation, highlighting the FDA's failed regulatory efforts on lab-developed tests. Political and legislative challenges hinder other reforms, and concerns over Medicare reimbursement cuts loom for the clinical lab industry.

More from Diagnostics

Sweden’s Sectra Expands Global Digital Pathology And AI Footprint

 
• By Ashley Yeo

Cloud services accounted for 85% of Sectra’s imaging IT solutions business in 2024-25, and the Swedish medical diagnostic imaging and IT for precision medicine company is further expanding its digital healthcare and AI coverage in the UK, wider Europe and US.

NextGen Dx Panel Expects Continued Limbo On LDT Regulation

 
• By Elizabeth Orr

A recent conference panel discussed the stagnation in diagnostics regulation, highlighting the FDA's failed regulatory efforts on lab-developed tests. Political and legislative challenges hinder other reforms, and concerns over Medicare reimbursement cuts loom for the clinical lab industry.

Quest’s Haystack MRD Wins FDA Breakthrough Status, Shows Exceptional ctDNA Sensitivity

 
• By Shubham Singh

Quest is actively building collaborations with academic and pharmaceutical partners to integrate Haystack MRD into clinical investigations. These partnerships are not yet public but span multiple tumor types and therapeutic areas, VP Dan Edelstein said.