LDTs
The constellation of challenges to implementing the IVDR by next year have prompted players to openly call for its postponement and phased implementation.
Rand Paul Reintroduces Bill Aimed at Blocking FDA Regulation of LDTs
First introduced in March of 2020, the VITAL Act would have LDTs regulated by the US Health and Human Services secretary under the Public Health Services Act.
Adaptive Cofounder and Chief Scientific Officer Harlan Robins compared the launch of the test to the unveiling of the Tesla Roadster electric sports car.
NanoString Technologies, OHSU Partner on Breast Cancer Spatial Protein Profiling Assay Development
A new GeoMx Digital Spatial Profiler assay will have up to 30 protein targets and will be validated for potential use as a laboratory-developed test.
Laboratory Stakeholders Weigh In On Biden Administration Priorities
The COVID-19 pandemic is the highest priority for most, but laboratory organizations are also looking ahead with longer-term goals for the new presidency.