Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Pathnostics UTI Test Nabs New York State Approval
The molecular test identifies organisms and resistance genes combined with pooled antibiotic susceptibility results.
FDA Approves Entrogen's RAS Mutation Detection Kit as CDx for Vectibix
The test, intended for use with Amgen's Vectibix, detects KRAS and NRAS exon 2, 3, and 4 mutations in colorectal cancer patients.
ProciseDx Gets US Marketing Clearance for Infliximab, Adalimumab POC Monitoring Tests
The firm plans this year to launch in the US its tests used to measure drug levels in inflammatory bowel disease patients and guide treatment.
ZeptoMetrix Quality Control Products Receive IVDR Certification
The company received an IVDR Quality Management System certification from notified body British Standards Institution.
FDA Grants Emergency Use Authorizations for POC COVID Tests from Tangen Biosciences, SD Biosensor
Tangen's test detects SARS-CoV-2 nucleic acid and runs on the firm's GeneSpark system, while SD Biosensor's lateral flow immunoassay detects the virus's nucleocapsid protein antigen.
Sep 29, 2023
Sep 21, 2023
Sep 19, 2023
Tasso Gets CE Mark for Blood Collection Device
Sep 13, 2023
Sep 11, 2023