STDs
Becton Dickinson High-Throughput MDx Module, Triplex STI Test Get FDA 510(k)Clearance
Along with a sample prep module, the BD Cor MX module is capable of delivering as many as 1,000 sample results in 24 hours.
As the firm continues to develop assays to run on a current batch-based MDx system, it seeks to develop a more flexible, random-access testing platform.
FDA Issues Clearances in April to Zeus Scientific, BioMérieux, Roche, Abbott, Others
Zeus Scientific obtained clearance for a test to detect IgG anti-nuclear antibodies and diagnose systemic rheumatic diseases such as systemic lupus erythematosus.
Abbott Nabs FDA Clearance for Multiplex Molecular STI Panel
The test runs on Abbott's PCR-based Alinity m instrument and can detect four sexually transmitted infections simultaneously.
New York State Approves Enzo Biochem HPV Molecular Test
Enzo expects to make several announcements related to other molecular laboratory-developed tests this year and provide a timeline for US FDA submissions.
Oct 4, 2021
Jul 22, 2021
CDC Updates STI Diagnosis, Treatment Guidelines
May 28, 2021
Binx Health Raises $104M in Series E Round
Mar 9, 2021
Apr 30, 2020