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.
Top Five Articles on 360Dx Last Week: Cue Health Layoffs; Handheld Dx Systems Development; and More
Last week, readers were most interested in Cue Health laying off 388 workers, or 26 percent of its staff, to reduce its costs.
Precision BioLogic Nabs FDA 510(k) Clearance for Factor IX Deficiency
The firm said its Cryocheck Chromogenic Factor IX test for managing hemophilia B is the only FDA-cleared chromogenic FIX assay on the US market.
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.