gonorrhea
BD Gets CE Mark, Australian Regulatory Approval for New Cor MX Instrument
The new MX instrument, which is based on the firm's BD Max PCR instrument, is the final component of the high-throughput BD Cor system.
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.
Mar 30, 2021
Binx Health Chlamydia and Gonorrhea Test CLIA Waived
Sep 9, 2020
Apr 30, 2020
FDA Provides Second Clearance for Binx MDx Platform
Nov 4, 2019
Oct 15, 2019
Enzo Biochem Fiscal Q4 Revenues Down 8 Percent
Aug 5, 2019
SpeeDx Raises $15M in Equity Investment
May 24, 2019
May 15, 2019