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.
Read MorePosted by Chris Wolski | Jun 3, 2025 | Compliance |
A federal court ruled in favor of AMP, striking down the FDA’s attempt to regulate laboratory-developed tests (LDTs) as medical devices.
Read MorePosted by Chris Wolski | May 15, 2025 | Compliance |
The ADLM has urged HHS to reinstate the CLIAC, warning that its elimination endangers test quality and patient care.
Read MorePosted by Chris Wolski | May 2, 2025 | Company News |
SSI Diagnostica Group is acquiring Gulf Coast Scientific to expand its gastrointestinal disease testing capabilities.
Read MorePosted by Chris Wolski | Apr 23, 2025 | Immunoassay |
Mitigating biotin interference on immunoassays is a critical factor to ensure appropriate diagnosis and treatment.
Read MorePosted by Chris Wolski | Apr 22, 2025 | Molecular Diagnostics |
bioMérieux has launched the WATCHFIRE R Panel, a rapid wastewater-based molecular test that detects 22 respiratory pathogens.
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