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FDA grants binx health CLIA-Waiver for its first-of-kind binx io platform for chlamydia and gonorrhea testing

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Revolutionary, CLIA-Waived, Point-of-Care Testing. That’s the binx io!!

Easy-to-use, molecular platform enabling single-visit diagnoses and treatment for chlamydia and gonorrhea.

Welcome to the future of sexually transmitted infection (STI) testing – the binx io. The io offers a new paradigm designed to enable improved health outcomes by:

  • Increasing treatment compliance
  • Limiting onward transmission
  • Minimizing the risk of untreated conditions
  • Ensuring the right treatment is provided

Lab-quality test results in about 30 minutes

Easy-to-Use

Collect sample, load cartridge, and press ‘start’

Rapid Results

View results in about 30 minutes

Lab-Quality Testing

Central laboratory equivalent performance at the point-of-care

binx io is a CLIA-Waived desktop instrument that processes a single-use, assay-specific cartridge with no sample preparation necessary. binx io is fully automated, easy-to-use, and does not require calibration or preventative maintenance. Simply load the cartridge and in about 30-minutes the io provides a result that does not require any interpretation. 

With billable testing administered under one roof, the io platform can generate valuable revenue for clinics. 

How the binx io works

The binx io platform combines ultra-rapid, polymerase chain reaction (PCR) amplification with binx health’s proprietary and highly-sensitive electrochemical detection technology. This combination enables the io to provide results equivalent to the central laboratory in about 30 minutes.

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*io®, the io Instrument®, and the io Cartridge® (together the “io Diagnostic System®”) are registered trademarks of binx health limited. Copyright © 2020 binx health, inc. The binx health io CT/NG Assay, when tested using the binx health io Instrument, is a fully automated, rapid, qualitative test intended for use in point-of-care or clinical laboratory settings for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA by polymerase chain reaction. The binx health io CT/NG Assay is intended for use with female vaginal swab specimens, collected either by a clinician or self-collected by a patient in a clinical setting, or male urine specimens, as an aid in the diagnosis of symptomatic or asymptomatic Chlamydia trachomatis and/or Neisseria gonorrhoeae infection. For a symptomatic male patient with a chlamydia negative test result, further testing with a laboratory-based molecular test is recommended.

¹ The U.S. Centers for Disease Control and Prevention (2018). 2018 SEXUALLY TRANSMITTED DISEASES SURVEILLANCE REPORT. Updated August 27, 2019. https://www.cdc.gov/std/stats18/default.htm.

²,³ Huang W, Gaydos CA et al (2012). Comparative effectiveness of a rapid point-of-care test for detection of Chlamydia trachomatis among women in a clinical setting. STI. 88. Published first online 14 Sept 2012. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3671871/

Published literature

Disclaimer:

The binx health io CT/NG Assay has been cleared by the United States Food and Drug Administration for use with female vaginal swab specimens, collected either by a clinician or self-collected by a patient in a clinical setting, or male urine specimens.

In April 2019, the binx health io CT/NG Assay received CE-marking for both female vaginal swab and male urine samples.