Loading...
CLIA-Waived, Point-of-Care Testing. That’s the binx io.
Easy-to-use, 30 minute, molecular platform enabling single-visit diagnoses and treatment prescription for chlamydia and gonorrhea.
The binx io offers a new paradigm with the potential 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
The first and only FDA-cleared, CLIA-waived, rapid, molecular point-of-care test for chlamydia and gonorrhea for males and females
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 an FDA-cleared, 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 offers the potential to generate revenue for clinics. The io platform offers the potential to generate revenue for clinics with well-established codes for reimbursement.
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.
Published Literature
- Van Der Pol, Barbara, et al. Evaluation of the Performance of a Point-of-Care Test for Chlamydia and Gonorrhea. JAMA Network Open 3(5) (2020): e204819
- Widdice, Lea E., et al. “Performance of the Atlas Genetics Rapid Test for Chlamydia trachomatis and Women’s Attitudes Toward Point-of-care Testing.” Sexually Transmitted Diseases. 45.11 (2018): 723-727.
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.
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/