binx FDA-cleared platform already impacting human health—poised to transform care for millions
September 23, 2019 (BOSTON, MA) PR NEWSWIRE
binx health, the pioneer in anywhere, anytime testing for women’s health, today announced the first real-world use of the binx io platform, delivering same-visit diagnosis and treatment for chlamydia (CT) and gonorrhea (NG)—the two most tested-for sexually transmitted infections (STIs) globally. The World Health Organization (WHO) has previously indicated that the lack of reliable, low-cost, point-of-care tests that enable diagnosis and treatment in a single visit represents a major barrier to sexually transmitted infection (STI) control and prevention. With the company’s recent CE Mark in Europe and FDA 510(k) clearance for rapid CT/NG testing, binx health is the first company to remove this barrier.
Under an Innovate UK SBRI grant, and in collaboration with three NHS Trusts and the Applied Diagnostic Research and Evaluation Unit at St. Georges University of London (SGUL), the binx io platform is now being used by clinicians to diagnose patients who otherwise would have faced up to several days of delay between infection identification and treatment.
Dr. Emily Mabonga, a clinical consultant from the Lewisham and Greenwich NHS Trust said, “So far, we have tested about 90 patients, have had 17 CT and two NG positives and were able to provide the right antibiotic in a single visit. British Association of Sexual Health and HIV quality standards suggest treatment within three weeks of testing. We can now provide the right antibiotic in one visit. This is game-changing for us.”
“We are thrilled to see these results from real-world settings benefiting the first patients ever,” commented Jeff Luber, binx health’s Chief Executive Officer. “The binx workflow involves sample collection at the start of an office visit, with results available with little or no wait time before the patient leaves with prescription in hand. For the 35,000 OB-GYNs in the United States, this offers the promise of a major paradigm shift in the management of sexual health and provider commitment to patient satisfaction.”
“The ability to accurately diagnose and treat a substantial number of people with chlamydia or gonorrhea in a single visit has been a real need for both patients and the sexual healthcare community that looks after them”, said Professor Tariq Sadiq, of SGUL, who led the implementation work. “The binx io platform provides a result in about 30 minutes with the accuracy on par with central laboratory systems; the feedback we are getting from clinicians is very encouraging. We continue to be excited by this effective collaboration with the binx team to serve this important clinical need.”
Given the duration of the average medical visit in the United States, the binx io can consistently deliver a result within the timeframe of a single visit, before the patient leaves the office. This enables the opportunity to test and treat in near-patient settings, at central lab accuracy, for millions who require screening under medical guidelines. In the Company’s recently completed 1,523-person, multi-center clinical study, 96% of patient samples were processed on the binx io by non-laboratorians in a point-of-care setting.Clinical study performance showed a 96.1% sensitivity and 99.1% specificity for chlamydia and 100% sensitivity and 99.9% specificity for gonorrhea in women tested. binx received its CE Mark for CT/NG in April 2019 and FDA 510(k) clearance in August 2019. The binx health io CT/NG Assay, when tested using the binx health io Instrument, is a fully automated, qualitative test intended for use in point-of-care or clinical laboratory settings for the rapid detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in female vaginal swab specimens collected either by a clinician or self-collected by a patient in a clinical setting.
For those whose focus is women’s health, rapid test-and-treat is of paramount importance. Undetected STIs can lead to a host of negative health outcomes, including infertility, pelvic inflammatory disease, ectopic pregnancies, and other co-morbidities that can often be avoided through early, rapid detection in near-patient settings. The CDC estimates that untreated STIs cause infertility in 24,000 women annually in the U.S. alone. Guidelines of American College of Obstetrics and Gynecology recommend CT/NG screening for all pregnant women and those trying to get pregnant. Rapid test and treat for these infections can be a central tool in overall reproductive health and wellness for millions annually.
ABOUT BINX HEALTH
binx health is the pioneer in anywhere care in women’s health for consumers where they live, work and shop. We do this through the development of (1) proprietary, rapid desktop PCR instruments for retail pharmacy, urgent care, primary care, health centers, and any other brick-and-mortar location where onsite, on-demand testing and rapid results on par with central lab testing, are paramount, and (2) mobile solutions for at-home, physician-ordered testing that aim to bring consumers from “worry-to-well” in the palm of their hands. Starting with sexually-transmitted infections, we aim to reverse trends of rising infections among young people, and move into broader family health through the expansion of our point-of-care and at-home offerings. binx health’s investors include financial investors Johnson & Johnson Innovation, Novartis Venture Fund, LSP, BB Biotech, RMI Investments and Technology Venture Partners and strategic investors Consort Medical (whose wholly owned subsidiary Bespak is the manufacturer of the company’s low-cost, proprietary multiplex cartridges) and China-based Wondfo Biotech.
St George’s, University of London (informally St George’s or SGUL, formerly St George’s Hospital Medical School) is a medical school located in London, United Kingdom and a constituent college of the University of London. St George’s has its origins in 1733, and was the second institution in England to provide formal training courses for doctors (after the University of Oxford). St George’s affiliated with the University of London soon after the latter’s establishment in 1836. As of 2008 St George’s medical school accepted around 100 graduates, 175 undergraduates and 10 students from overseas making it one of the largest medical schools in the UK. St George’s is closely affiliated to St George’s Hospital and is one of the United Hospitals. Website http://www.sgul.ac.uk/Wikipedia http://en.wikipedia.org/wiki/St_George%27s,_University_of_London
Ray, K. N., Chari, A. V., Engberg, J., Bertolet, M., & Mehrotra, A. (2015). Opportunity costs of ambulatory medical care in the United States. Am J Manag Care, 21(8), 567-574.https://www.ajmc.com/journals/issue/2015/2015-vol21-n8/opportunity-costs-of-ambulatory-medical-care-in-the-united-states