AMP Celebrates Decision to Vacate FDA Rule on LDT Regs
A federal court ruled in favor of AMP, striking down the FDA’s attempt to regulate laboratory-developed tests (LDTs) as medical devices.
A federal court ruled in favor of AMP, striking down the FDA’s attempt to regulate laboratory-developed tests (LDTs) as medical devices.
A recent court ruling excluding LDTs from FDA regulation highlights the urgent need for the diagnostics industry to modernize oversight.
Researchers have developed a new bioluminescence-based diagnostic tool that offers virus detection in complex biological samples.
Festo's SupraMotion uses superconducting technology to enable automated, contactless handling across sterile and non-sterile environments.
Labcorp has expanded its precision oncology portfolio with new tests for solid tumors and blood cancers to support diagnostic development.