binx health Announces Publication of Pivotal Study in JAMA Network Open

Study signals "real paradigm shift" in care resulting from the world's first FDA-cleared, 30-minute, molecular point-of-care platform for the detection of chlamydia and gonorrhea

BOSTON, May 14, 2020 /PRNewswire/ -- binx health today announced the publication of its pivotal clinical study for its rapid molecular point-of-care platform, the binx io, in The Journal of the American Medical Association (JAMA) Network Open. The study shows that the binx io provides accurate results in about 30 minutes, enabling single visit test and treatment for chlamydia (CT) and gonorrhea (NG), two of the most tested-for sexually transmitted infections (STIs) globally. binx received FDA 510(k) clearance for its CT/NG Assay in August 2019 for female swabs and in April 2020 for male urine samples. The standard of care today for CT/NG testing often requires 2-10 days of delay between sample collection and answer, resulting up to 40% of positive patients not returning for treatment¹.

With CT/NG infections already at record highs—and the broad cessation of routine STI testing related to impacts of COVID-19²—the need for the binx io rapid, molecular point-of-care platform is especially acute. The World Health Organization (WHO) estimates each year there are 127 million new chlamydia and 87 million new gonorrhea infections globally.

According to the publication's authors, "The availability of an easy-to-use, rapid (30-minute) molecular test for accurate detection of chlamydia and gonorrhea has the power to facilitate testing and treatment in a single patient visit for these STIs." The study's findings further convey that the binx io platform can potentially create a paradigm shift in care by enabling, for the first time ever, testing and treatment in a single visit. With only five minutes of initial user training, and one minute of hands on operator time per testing cycle, the binx io's ease of use has the potential to become ubiquitous on the front lines of sexual health and wellness.

Barbara Van Der Pol, MPH, PhD, President of the American Sexually Transmitted Diseases Association and Principal Investigator of the clinical study at the University of Alabama at Birmingham, described the binx io CT/NG assay as "a highly accurate test that allows rapid results to be available during the patient visit. In combination with changing how we offer sexual health screening, this test has the capacity to truly shift the paradigm for STI control efforts".

Charlotte Gaydos, MPH, DrPH, Professor Emerita at Johns Hopkins University School of Medicine Center for Point-of-Care Technologies Research for Sexually Transmitted Diseases, echoed these remarks, adding, "This progress in rapid point-of-care detection of chlamydia and gonorrhea has the potential to be a game changer for making progress toward immediate treatment of the infection thus preventing forward transmission of the infection."

Dr. Adam Sukhija-Cohen, Director of Advocacy and Policy Research at AIDS Healthcare Foundation, one of the larger sites to participate in the pivotal study, said "Rising STI rates in the United States require innovative and rapid approaches to STI testing and treatment. As an organization that provides free walk-in HIV/STI testing for hundreds of thousands of clients each year in the United States, point-of-care testing for chlamydia and gonorrhea, like the binx io, can help curb the further spread of these two infections".

Highlights from the study include:

• Female CT sensitivity and specificity were 96.1% and 99.1%, respectively. Female NG sensitivity and specificity were 100.0% and 99.9%, respectively.
• Male CT sensitivity and specificity were 92.5% and 99.3%, respectively. Male NG sensitivity and specificity were 97.3% and 100.00%, respectively.
• Equivalent performance was observed between asymptomatic and symptomatic patients (male and female) and between patient and clinician-collected samples in females.
• 95% of study patient samples were processed on the binx io in point-of-care settings by non-laboratorians (e.g., nurses, office administrative staff).
• The binx io CT/NG Assay performance was compared to a composite of three FDA-cleared tests.

As reported today in Jama Network Open[3], the prospective clinical study conducted in support of binx' FDA 510(k) clearances, found that the highly accurate and rapid binx io may not only facilitate testing in new settings and improve sexual health by identifying infections earlier and reducing transmissions but also help to destigmatize  STI testing. The study compared the performance of the binx io CT/NG Assay to a composite of three FDA-cleared standard of care reference laboratory testing platforms for chlamydia and gonorrhea. The study recruited 2,445 eligible symptomatic and asymptomatic male and female patients attending STI clinics, OBGYNs, HIV clinics and family planning facilities in eleven locations across the United States. For women, a self or clinician-collected vaginal swab was obtained, with men collecting a first-catch urine specimen for analysis.

binx health io Instrument and CT/NG Assay

• io Instrument processes the single-use, CT/NG cartridge that contains all reagents for use on self- or clinician-collected vaginal swabs or male urine samples, with no sample prep required
• Intended for use in point-of-care or clinical laboratory settings
• No instrument calibration or preventive maintenance required
• Intuitive touch-screen operation
• Easy-to-follow screen prompts to start the test which is fully-automated –
• no further user interaction is required
• Qualitative, easy-to-understand results with no interpretation required
• Ambient temperature cartridge storage

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 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-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 healthcare lies at the nexus of testing convenience, rigorous science, and consumer relationships with a rapidly expanding retail health landscape.

Contact:

Cassie Arnold
KMA & Company
408-621-0700
cassie@KMAandCo.com

¹ 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/ 
² https://www.theverge.com/2020/4/21/21229776/sti-hiv-increase-coronavirus-response-contact-tracing 
3 Van Der Pol B et al. JAMA Network Open. 2020;3(5):e204819. doi:10.1001/jamanetworkopen.2020.4819