gonorrhea
LetsGetChecked Nabs FDA Marketing Authorization for Chlamydia, Gonorrhea Test
The assay is the first test for chlamydia and gonorrhea with at-home sample collection to receive marketing authorization, according to the agency.
Aptitude Medical Systems Gets Gates Foundation Grant for At-Home STI Test
The funding will support development of a point-of-care and over-the-counter molecular diagnostic to detect chlamydia, gonorrhea, and trichomonas.
The firm plans to file for regulatory approval of its first test, a chemiluminescent ELISA for respiratory disease, as early as the first quarter of 2024.
In recent CDC data, racial and sexual orientation minorities, especially, have been disproportionately affected by STDs.
Branded InSignia, the patented technology will first be incorporated into a gonorrhea antimicrobial susceptibility assay, followed by a point-of-care test.
Oct 4, 2021
Sep 2, 2021
May 28, 2021
Mar 30, 2021
Binx Health Chlamydia and Gonorrhea Test CLIA Waived
Apr 30, 2020
FDA Provides Second Clearance for Binx MDx Platform
Dec 12, 2019
Nov 4, 2019
Oct 15, 2019