Study reports 93% sensitivity and 99% specificity in 30-minute desktop instrument
BOSTON, Dec. 18, 2018 /PRNewswire/ -- Patients wondering if they have the sexually transmitted infections ("STI") chlamydia or gonorrhea may soon be able to get the results in about 30 minutes, according to new research funded through the National Institutes of Health. The binx health (formerly Atlas Genetics) result could lead to immediate treatment and an associated reduction in the spread of the infection. The World Health Organization has identified chlamydia and gonorrhea, among the most prevalent STIs, as organisms without an available point-of-care (POC) test. The binx health platform is now the subject of intense research, including an ongoing pivotal clinical study in the US across 17 sites and 5,000 patients, which will be submitted to the FDA in 2019 for 510(k) clearance.
This pilot study, authored by Lea Widdice, and published in the journal Sexually Transmitted Diseases, was funded by the United States' NIH's National Institute of Biomedical Imaging and Bioengineering (NIBIB). A team at Johns Hopkins University, Center for the Development of Point-of-Care Technologies for STIs, led by director Charlotte Gaydos, MS, MPH, DrPH, tested binx' rapid POC test for STIs at clinics in Maryland and Ohio. The study, consisting of 296 recruited patients, determined the binx test provided an accurate positive result 93 percent of the time and an accurate negative result 99 percent of the time for vaginal self-obtained swabs.
Without a POC test, patients typically receive STI results anywhere between two days and two weeks after providing the sample, with nearly 40% not returning for treatment and continuing to be at risk for spreading infection. Publications have shown that delays like these, between testing and treatment, inhibit timely patient care and can often result in inappropriate empiric antibiotic treatment, which is contributing to the alarming increase in antibiotic resistance of many organisms.
"The study not only validated the sensitivity and specificity of the test but also showed that most women are willing to wait in the doctor's office for the result of a rapid POC result in order to be treated promptly," said Howard M. Heller, MD, MPH, binx' Chief Medical Officer. "Treating the patient immediately not only lowers the likelihood of chlamydia transmission to others but also saves the clinician time that would be required for contacting the patient for results reporting, assuring treatment adherence and discussing partner notification and treatment."
"POC tests for STDs are making significant progress towards being highly sensitive, specific and easy-to-read within a short wait time," said Tiffani Bailey Lash, Ph.D., director of the NIBIB programs in Point-of-Care Technologies and Connected Health (mHealth and Telehealth).
"It takes time and money for POC technologies to get to the market," said Dr. Gaydos. "The goal of POC technology is to deliver quick results on a mobile platform, giving patients more options. A patient should be able to choose if he or she comes into a clinic, goes to a pharmacy, or takes a test at home for STD diagnosis; the bottom line is to encourage people to get tested."
binx health is the only company with STI platforms in both POC and mobile digital being developed to serve consumers where they live, work and shop. Onsite brick-and-mortar solutions plus at-home digital delivery methods offer the combination needed for broadest access and screening impact. binx' proprietary desktop POC platform is designed to perform rapid and accurate PCR amplification and electrochemical detection and provides a result in about 30 minutes. The Company is also developing mobile and digital solutions for at-home testing in order to broaden patient access under the oversight of licensed physicians for thoughtful, evidence-based care delivery. Together, the Company's POC and digital health offerings will meet people where testing is most convenient for them whether at home, in the supermarket, at their retail pharmacy, or at a wellness fair at work.
About binx health
binx health is creating new categories of healthcare solutions by striving to improve sexual health and wellness through new delivery methods that allow for convenient sexually transmitted infection (STI) testing for rapid test and treat. With its proprietary, desktop, PCR-based point-of-care testing platforms and consumer mobile offerings, the company is redefining "convenient health" for the modern consumer. binx is developing a suite of offerings that service healthcare needs where people live, work and shop. The Company's io platform is designed to be easy-to-use, allowing non-laboratory trained users to run a test, in about 30 minutes, with the same accuracy as a lab test and is therefore suitable for placing in primary care, retail pharmacies, supermarkets, and anywhere else consumers are likely to seek convenient, onsite testing. binx is driving solutions to take place in retail clinics, supermarkets, primary care offices, and at home. It does it through a suite of mobile and digital offerings. binx health investors includes financial investors, Johnson & Johnson Innovation, Novartis Venture Fund, LSP Venture Capital, BB Biotech, RMI Investments and Southwest Ventures Fund and strategic investors, Consort Medical (whose wholly owned subsidiary Bespak are the makers of the company's low-cost, proprietary multi-plex cartridges) and China-based Wondfo Biotech.
Contact: Brian Heffron, bheffron@ctpboston.com, 781.799.9568
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