FDA clearance
Prenetics' ACT Genomics Profiling Test for Solid Tumors Receives FDA Clearance
The regulatory clearance of ACTOnco comes on the heels of Prenetics' acquisition of a majority stake of ACT Genomics last month.
FDA Approves Foundation Medicine Blood Test as CDx for Rozlytrek
FoundationOne Liquid CDx, a liquid biopsy test, is the only blood-based CDx approved for the targeted cancer therapy.
FDA Revises, Expands Yale SalivaDirect Emergency Use Authorization
The FDA expanded the Emergency Use Authorization of the Yale test to include use with additional thermal cyclers and software.
FDA Approves Thermo Fisher HLA Typing Test as CDx for Immunocore Uveal Melanoma Therapy
The marketing authorization makes Thermo Fisher’s SeCore CDx HLA Sequencing System the first and so far only commercially available HLA typing companion diagnostic.
FDA Clears Grifols AAT Deficiency Test, OraSure Saliva Collection Device for Over-the-Counter Use
The test screens for genetic mutations commonly associated with the condition and can now be used with OraSure Technologies' ORAcollect Dx collection device.
Sep 8, 2020
FDA Clears DiaSorin Test for Influenza, RSV
Sep 8, 2020