gonorrhea
As the pandemic continues to play out, test developers aren't sure how it will impact STIs and their work around developing and manufacturing tests.
The firm received clearance and CLIA waiver for a 30-minute point-of-care PCR assay for three common STIs earlier this week.
Visby Medical Obtains FDA 510(k), CLIA Waiver for Multiplex STI Test Using Handheld PCR Device
The CLIA waiver enables clinicians to run a 30-minute multiplex test for chlamydia, gonorrhea, and trichomonas during a patient's visit.
The Hopkins team expects to spinout a company soon in order to commercialize the technology in the next two to three years.
Binx Health Partners With Walgreens to Offer At-Home Test Collection Kits for STIs
Binx Health said its sample collection kits are sent to the home, and self-collected samples are returned to a CLIA-certified laboratory partner for processing.
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
Enzo Biochem Fiscal Q4 Revenues Down 8 Percent
Sep 11, 2019
Aug 5, 2019