FDA clearance
23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test
The firm is now authorized to sell a genetic health report on the HOXB13 marker that indicates risk for hereditary prostate cancer, its third DTC cancer risk report with 510(k) clearance.
Thermo Fisher Scientific, Diazyme Laboratories, Rheonix, Others Obtain FDA Clearances in December
Thermo Fisher got the nod for its Sensititre 18 to 24 hour minimum inhibitory concentration or breakpoint susceptibility system with cefiderocol.
Copan Diagnostics Receives FDA 510(k) Clearance for Colibri Clinical Microbiology System
The system is intended for use with mass spectrometry microbiology platforms for automating the identification of Gram-negative and Gram-positive bacteria.
Meridian Bioscience Campylobacter Assay Receives FDA Clearance
The rapid fluorescent immunoassay detects a Campylobacter-specific antigen and provides results in approximately 20 minutes.
FDA Approves Thermo Fisher Scientific Oncomine Dx Assay as CDx for Janssen Lung Cancer Drug
The Oncomine Dx Target Test will be used as a companion diagnostic to identify NSCLC patients whose tumors carry EGFR Exon20-insertion mutations.