Visby Medical Point-of-Care STI Test Gets FDA 510(k) Clearance, CLIA Waiver
The PCR test detects sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in women.
Binx Health Chlamydia and Gonorrhea Test CLIA Waived
The 30-minute test can be used on samples from males and females in settings operating under a CLIA certificate of waiver.
The company is currently working on multiple infectious disease products, including a panel for sexually transmitted infections and one for SARS-CoV-2.
Visby Medical Gonorrhea Test Wins $19M AMR Diagnostic Competition
The PCR diagnostic device is a palm-size, single-use, disposable device that detects N. gonorrhoeae and determines if it's susceptible to an antibiotic.
New York State Approves Enzo Biochem STI Tests on GenFlex Platform
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.