binx offers first FDA 510(k) cleared molecular point-of-care solution for test and treat of sexually-transmitted infections in a single visit
BOSTON, Jan. 13, 2020 / PRNewswire
binx health today announced the launch of its pre-order program for the world’s first FDA-cleared, rapid molecular point-of-care instrument, which provides diagnosis in about 30 minutes to enable single visit test and treatment for chlamydia (CT) and gonorrhea (NG) in women. CT and NG are two of the most tested-for sexually transmitted infections (STIs) globally. binx received FDA 510(k) clearance in August 2019 for its female offering, and is submitting a 510(k) filing for its male urine offering in Q1 2020.
The World Health Organization (WHO) estimates each year there are 127 million new chlamydia and 87 million new gonorrhea infections globally. With CT/NG infections at record highs, and published data showing up to 40% of positive patients not returning for treatment once they leave a physician’s office, the need for the binx rapid platform is acute. In a recent proprietary survey of 116 practicing OB-GYNs, 74% reported that a 30-minute rapid platform would fit into current care pathways, with these same OB-GYNs indicating that they were “likely to adopt” the platform in their practices.
“Since our FDA 510(k) clearance in August 2019, the inbound interest from hospital systems, large OB-GYN practices, STI clinics, urgent care centers, retail pharmacies and others on the front lines of sexual health has far exceeded expectations,” remarked Jeffrey Luber, binx health CEO. “Our product enables single visit test and treat in environments where traditional care pathways require patients to wait up to several days for results, with many positive patients not returning for treatment once they leave a doctor’s office. Care providers will soon be able to receive a small, desktop instrument from binx and deliver rapid and accurate diagnoses onsite, enabling treatment before the patient leaves the office. This is the start of a paradigm shift in care for millions.”
“Our recent UK pilot, launched following our receipt of CE Mark in 2019, has resulted in hundreds of male and female patients being tested for CT and NG and, for the first time, positive patients are now leaving with prescription in hand, rather than waiting up to twenty-one days for a result, as can be typical in some of these settings,” said Anna Dixon, the company’s Chief Technology Officer. “Our io platform and CT/NG products have seen very high rates of clinician satisfaction and strong interest in product acquisition for the long-term from these same clinics.”
binx health io Instrument and CT/NG Assay
- Intended for use in point-of-care (clinic, doctors’ office) or clinical laboratory settings
- No instrument calibration or preventive maintenance required
- Intuitive touch-screen operation, with easy-to-follow screen prompts to start the test which is fully-automated – no further user interaction is required
- Processes a single-use, assay-specific cartridge containing all reagents for use on a self- or clinical-collected vaginal swab (no sample prep required)
- Qualitative, easy-to-understand results with no interpretation required
- Ambient temperature cartridge storage
In the Company’s recently completed pivotal 1,523-person, multi-center clinical study, 96% of patient vaginal swab samples were processed on the binx io by non-laboratorians in a point-of-care setting. Clinical study performance demonstrated 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 male urine and female vaginal swab samples in April 2019 and its FDA 510(k) clearance for CT/NG in female vaginal swab samples 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.
Pre-order program details
The Company is pleased to offer pre-orders for the io Instrument under both capital purchases or under a reagent rental agreement. For more information, or to pre-order, please visit binx-io.com.
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.