chlamydia
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.
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.
Binx Health said that when it received FDA CLIA waiver, it already had a strategic partner for sales of its POC platform and chlamydia and gonorrhea tests.
CARB-X Commits up to $13.8M to Novel Microdevices for Point-of-Care STI Test
Novel Microdevices is developing a portable, sample-to-answer instrument that is designed to perform molecular testing on untreated patient samples.
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
Oct 15, 2019
Enzo Biochem Fiscal Q4 Revenues Down 8 Percent
Sep 11, 2019
Aug 5, 2019
SpeeDx Raises $15M in Equity Investment
May 24, 2019
May 15, 2019