Clinical laboratories still face uncertainty and the difficult decision of whether to start the work needed to comply with ...

We discussed the details of the LDT Final Rule in a previous Insight, explaining that as of the May 6, 2025 Phase 1 deadline FDA will expect all laboratories that manufacture LDTs to comply with ...

The pathologists group wants the regulation terminated in light of an executive order from President Trump that calls for ...

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2024 –The Food and Drug Administration’s (FDA) final rule has reclassified laboratory developed tests (LDTs) as medical devices, according to Avalere. The rule leads to a paradigm shift that ...

An example of these ongoing threats recently materialised in the FDA’s final rule on laboratory-developed tests (LDTs). This recent change, which will be phased out in four years, categorises ...

Such tests are increasingly moving beyond their origins in cutting-edge research and into the laboratory and diagnostic ...

SEQ is the only DLBCL MRD assay available for clinical use and covered by Medicare SEATTLE, (GLOBE NEWSWIRE) --  Adaptive ...

The Food and Drug Administration released a final rule on LDTs in April. Despite industry opposition, the agency has changed the regulations to classify diagnostics made by laboratories as medical ...

Affinity Technologies today announced strategic actions to cut $4 million in annual costs at its subsidiary CAP/CLIA ...