FDA
FDA Grants EUA for Scope Molecular Laboratory SARS-CoV-2 Test for Serial Testing
The laboratory-developed test uses RT-PCR to detect SARS-CoV-2 RNA in anterior nasal swab specimens either self-collected or collected by a healthcare professional.
DiaCarta Nabs FDA Emergency Use Authorization for Monkeypox Test
The laboratory-use QuantiVirus MPXV Test Kit targets two regions of the MPXV genome to detect the virus even if mutations occur in one target region.
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.
Becton Dickinson Monkeypox PCR Assay Granted FDA Emergency Use Authorization
The PCR test is designed to qualitatively detect monkeypox virus DNA in human lesion swab samples from patients suspected of monkeypox infection.