Binx Health Receives FDA 510k Clearance - Binx Health Receives FDA 510k Clearance - JHU
binx health Receives FDA 510(k) Clearance For Rapid Point Of Care Platform For Women's Health
BOSTON, Aug. 12, 2019
binx health, the pioneer in anywhere, anytime testing for women's health, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its first-of-kind, highly sensitive and specific, molecular point-of-care (POC) diagnostic testing platform, the binx io®. The binx ioplatform is a rapid, qualitative, fully-automated test, designed to be easy to use, and intended for use in POC or clinical laboratory settings, providing the world's first sample-to-answer result in about 30 minutes for the detection of chlamydia (CT) and gonorrhea (NG)—the two most tested-for STIs globally. 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 POC setting.
"Today we announced a significant health milestone toward making STI testing rapid and convenient with a platform profile and performance levels with the potential to vastly improve health outcomes for millions of women in the United States," said Jeff Luber, President and CEO of binx health. "With the 'front door' of healthcare increasingly moving to near-patient settings, today's FDA clearance puts the power of rapid onsite care where consumers need it most—in the communities where they live, work and shop."
STIs have been rising dramatically and are a growing global public health crisis. The World Health Organization (WHO) estimates more than one million STIs are acquired every day2, and recently remarked on the rise in STIs as "a hidden epidemic, a silent epidemic, a dangerous epidemic," stating the growing rate of infection should be "'a wake-up call' for authorities to "ensure that everybody had access to services to prevent and treat STIs". In the United States, the CDC has reported that only 12%3 of people aged 15-25 who should be screened annually have been screened for STIs, despite their carrying 50% of the annual infection burden. In women, undetected STIs can lead to a host of reproductive health problems, 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 binx io is a robust and easy to use diagnostic platform, has the ability to multiplex up to 24 targets, and requires no calibration or maintenance. The platform consists of a small, benchtop instrument and single-use, assay-specific cartridge that can process an unprocessed patient sample with no user interaction once the sample is added to the cartridge. The cartridge contains all reagents needed for the assay and uses PCR amplification and binx' proprietary electrochemical detection technology to provide rapid and accurate results. The io has been cleared for use in point-of-care or clinical laboratory settings for the detection of chlamydia and gonorrhea in female vaginal swab samples collected either by a clinician or self-collected by a patient in a clinical setting.
"The binx io platform is elegant in design and powerful in detection ability," said Dr. Anna Dixon, the company's Chief Technology Officer. "Having achieved clearance for CT/NG and with this strong predicate now in place, we're excited to now move our other robust sexual wellness assays toward regulatory filing."
CLINICAL TRIAL RESULTS
In a recent multi-center clinical trial encompassing 17 evaluation centers and more than 1,500 symptomatic and asymptomatic patients, the binx io was demonstrated to be an accurate and reliable test platform when compared to the current central lab standard of care systems for two of the most common STIs, chlamydia and gonorrhea, in women. Clinical study performance showed a 96.1% sensitivity and 99.1% specificity for chlamydia and 100% sensitivity and 99.9% specificity for gonorrhea testing in women tested.
"Our experience testing the binx io system revealed a potentially major paradigm shift in the process of addressing STIs," said Dr. Barbara Van Der Pol, president of the American STD Association, director of a diagnostic lab at the University of Alabama at Birmingham School of Medicine. "During a recent evaluation4, we found that a high proportion of patients were willing to wait when presented with the possibility of rapid results, suggesting that test-and-treat in the same visit is possible for the first time."
CDC, USPSTF and ACOG all recommend annual screening for chlamydia and gonorrhea in sexually-active women under age 25, for all pregnant women under age 24, and in older women at increased risk of infection.5,6,7 CDC also recommends retesting three months after treatment8. ACOG and CDC further recommend that chlamydia and gonorrhea testing be conducted using nucleic acid amplification techniques (NAAT) on vaginal swab—the technical approach and sample type for which the binx io was cleared by the FDA.9
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.
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/
4 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/
5 Final Recommendation Statement: Chlamydia and Gonorrhea: Screening. U.S. Preventive Services Task Force. May 2019.
6 Final Recommendation Statement: Chlamydia and Gonorrhea: Screening. U.S. Preventive Services Task Force. May 2019.
7 Keegan MB, Diedrich JT, Peipert JF. Chlamydia trachomatis Infection: Screening and Management. J Clin Outcomes Manag. 2014;21(1):30–38.
8 Final Recommendation Statement: Chlamydia and Gonorrhea: Screening. U.S. Preventive Services Task Force. May 2019. https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/chlamydia-and-gonorrhea-screening
9 Keegan MB, Diedrich JT, Peipert JF. Chlamydia trachomatis Infection: Screening and Management. J Clin Outcomes Manag. 2014;21(1):30–38.
SOURCE binx health, inc