Latest FDA clearance establishes binx as the fastest dual-gender rapid test-and-treat platform for chlamydia and gonorrhea
COVID-19 pandemic has created growing backlog of millions in need of routine STI testing
BOSTON, April 30, 2020 / PRNewswire
binx health, a leader in infectious disease testing solutions, announced that it has received a second 510(k) clearance from the U.S. Food and Drug Administration (FDA) in one of the largest markets for infectious disease testing. Today, the Company announces FDA 510(k) clearance to market its sensitive and specific, molecular point-of-care testing platform, the binx io, for the detection of chlamydia (CT) and gonorrhea (NG)—the two most tested-for STIs globally—in male urine specimens. The Company previously announced, in August of 2019, FDA 510(k) clearance of the binx io for use with clinician and self-collected vaginal swab specimens.
Uniquely, the binx io platform has the proven ability to rapidly detect complex infectious disease targets from bodily fluids at very high accuracy. In a world of emerging bacterial and viral threats, point-of-care platforms like the binx io are essential to broadening access to needed testing everywhere, while decreasing the burden in traditional healthcare settings.
Experts refer to STIs as a growing and “silent epidemic,” with the World Health Organization (WHO) estimating that people worldwide contract 376 million new sexually transmitted infections (STIs) every year. These include 126 million cases of chlamydia and 87 million cases of gonorrhea—diseases that can be painful in the short term and can contribute to an increased risk of infertility, among other chronic health problems, if left untreated.
“Clearance of the binx io male CT/NG test couldn’t have come at a better time”, said David C. Harvey, executive director, National Coalition of STD Directors. “Chlamydia and gonorrhea rates are high, climbing, and show no signs of slowing. Our field needs impactful, rapid, and easily deployable tools in the STI diagnostics toolbox, and the binx io is a welcome and much needed addition to our arsenal.”
“In order to slow the growth of rising sexually transmitted infections, ease of use and rapid answers during a single clinical encounter are essential,” said binx CEO, Jeff Luber. “Point-of-care testing will continue to be more widely adopted as a critical tool in infection control globally. With increasing numbers of large retail players moving into healthcare, we look forward to working with partners to expand onsite infectious disease testing for the millions who need it.”
The binx io platform is a rapid, qualitative, fully automated molecular test, designed to be easy to use, and intended for use at the point of care or clinical laboratory settings. The io is a robust but highly flexible platform which couples PCR amplification and proprietary electrochemical detection technology for sensitive analyte detection and continues to be the world’s first and only molecular platform enabling single-visit test and treatment for chlamydia and gonorrhea in about 30 minutes.
binx’s multi-center clinical trial involved 10 evaluation sites across the United States and collected samples from 922 male symptomatic and asymptomatic patients. The binx io was demonstrated to be an accurate and reliable test platform when compared to current standard of care central laboratory systems for chlamydia and gonorrhea. In the male arm of the study (which is the focus of this FDA clearance), 94% of all patient samples were processed by non-laboratorians in point-of-care settings. Clinical study performance for male urine specimens run on the binx io and compared to three FDA-cleared laboratory tests showed a 92.5% sensitivity and 99.3% specificity for chlamydia and 97.3% sensitivity and 100% specificity for gonorrhea.
binx health io Instrument and CT/NG Assay
- Intended for use in point-of-care or clinical laboratory settings
- The io Instrument processes the single-use, CT/NG cartridge that contains all reagents for use on self- or clinician-collected vaginal swabs and male urine samples. No sample prep required.
- Proprietary highly sensitive electrochemical detection technology
- Intuitive touch-screen operation with easy-to-follow screen prompts to start the fully automated test – no further user interaction is required
- Qualitative, easy-to-understand results with no interpretation required
- Ambient temperature cartridge storage
- No instrument calibration or preventive maintenance required
In January, the Company successfully launched its binx io pre-order program for female samples under both capital purchases and through a reagent rental agreement. With today’s FDA clearance, this program now extends to both male and female samples. For more information, or to pre-order, please visit http://binx-io.com/
ABOUT BINX HEALTH
binx health brings rapid, accurate and convenient infectious disease testing to people where they live, work and shop. Our solutions broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere, including in the ever-expanding footprint of retail health. The FDA cleared, binx io system is a highly flexible and easy-to-use, molecular point-of-care platform leveraging patented, multiplex technology to enable central lab equivalent clinical performance in decentralized, near patient locations such as OB-GYN and primary care, retail pharmacy, urgent care, and the large and evolving category of consumer “super stores,” that are increasingly serving customer health needs. Our large partners seek to serve the testing needs of both in-clinic/store and at-home populations. In addition to the binx io onsite care platform above, binx has also developed a suite of medical guideline driven, at-home testing solutions to reach the many who are unwilling or unable to visit a physical location. We believe the future of near-patient healthcare lies at the nexus of testing convenience, rigorous science, and consumer relationships with a rapidly expanding retail health landscape.