While many advocate that oversight of AI analyses of lab data be handled through CLIA, some stakeholders say that FDA should play a role.
After two decades effecting change in commercial diagnostics, this achievement is the brightest spot of my career, with a profound culmination of scientific, clinical, and social impact," —Elizabeth ...
FOSTER CITY, Calif., May 28, 2025 /PRNewswire/ -- 1Cell.Ai, a precision oncology company developing advanced cell and molecular profiling platforms, announced the successful completion of a CLIA-grade ...
The successful translation of biomarker discoveries into actionable diagnostic tools requires strict adherence to the robust regulations governing clinical proteomics. As mass spectrometry and ...