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Association for Molecular Pathology Applauds U.S. District Court’s Ruling to Overturn FDA Regulation on Laboratory-Developed Tests
- The U.S. District Court's ruling overturned FDA regulation on Laboratory-Developed Tests, marking a significant victory for AMP and Dr. Michael Laposata.
- The ruling vacated the FDA's regulatory framework that classified LDTs as medical devices under strict guidelines.
- President of AMP, Jane S. Gibson, expressed optimism about the end of FDA's perceived regulatory overreach on LDTs.
- LDTs have been crucial for clinical advancements, including rare diseases, genomics, and cancer biomarker testing.
- The court's decision prevents potential healthcare cost escalation and ensures continued access to innovative diagnostics.
- The ruling reinforces the value of LDTs developed and interpreted by expert clinicians in regulated laboratories.
- Dr. Eric Konnick emphasized the ruling's affirmation of the necessity for laboratories to operate without undue regulatory burden.
- AMP advocates for legislative clarity surrounding LDT oversight, collaborating with lawmakers for patient access to diagnostics.
- Despite the ruling, discussions on LDT regulation highlighting the balance between innovation and safety continue in the healthcare sector.
- AMP's advocacy focuses on enhancing existing CLIA regulations to ensure quality, reliability, and innovation in LDTs.
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