First ever 30-minute, CLIA-waived, molecular PCR Test for CT/NG now available for OBGYN, physician offices and retail settings holding certificates of waiver
Boston, MA, March 30, 2021
binx health, a population health technology company that provides convenient healthcare solutions, announced today that the US Food and Drug Administration (FDA) has granted Clinical Laboratory Improvement Amendments (CLIA) waiver for the binx io system, a first-of-its kind molecular point-of-care testing platform capable of delivering central laboratory quality results in about 30 minutes, for the detection of chlamydia (CT) and gonorrhea (NG). The platform was previously 510(k) cleared by the FDA for testing male and female samples in moderate and high-complexity locations.
“With ever increasing sexually transmitted infection (STI) rates, point-of-care and CLIA-waived platforms like the binx io are essential additions to our STI control toolbox, which will increase accessibility and decrease the burden on traditional healthcare settings,” said Barbara Van Der Pol, PhD, MPH, Professor of Medicine and Public Health at University of Alabama at Birmingham.
CLIA waiver clearance allows binx to facilitate single visit testing for CT/NG in any of the more than 220,000 locations across the Unites States holding a CLIA certificate of waiver, including convenient and accessible locations such as OBGYN and primary care offices, urgent care facilities, community health clinics, STD clinics and retail settings. Single-visit diagnosis and treatment have the potential to improve treatment compliance and reduce STI transmission across communities.
“Clinicians on the front lines of sexual health and wellness have long needed options for rapid diagnostic tools to address the epidemic growth in STIs. In a healthcare landscape where consumer convenience and rapid answers are an imperative, the binx io is the first chlamydia and gonorrhea test to be used in near patient settings combining the features essential to meet these needs in a critically important area of sexual health,” said Jeffrey Luber, binx Chief Executive Officer. “The io Instrument’s demonstrated clinical effectiveness, ease of operation, and patient convenience make it a much-needed tool with transformative implications for public health, especially now during the COVID-19 pandemic where STI prevention services nationwide have been dramatically reduced or cut altogether as resources have been allocated to focus on the COVID response. We are grateful to the countless scientists, physicians, and key opinion leaders who played an important role in today’s watershed event.”
The CDC estimates that 1 in 5 people in the U.S.1 have an STI; based on CDC and USPSTF guidelines There are an estimated 108M people in the United States, for whom regular STI testing is appropriate.2 3
Today, nearly all CT/NG tests are processed at central laboratories, with a delay between diagnoses and treatment in many cases of several days or more, which often results in infected patients not returning for treatment. Data show that treatment delays may lead to onward transmission and serious health consequences particularly in women, with 10-15% of un-treated women experiencing Pelvic Inflammatory Disease and nearly 30,000 cases of infertility annually in the US related to undetected chlamydia4. Due to these delays, and potentially detrimental follow-on health effects, published data5 also show that clinicians are more likely to presumptively treat symptomatic patients with antibiotics while the patient is in the clinic rather than wait for central laboratory test results. Inappropriate antibiotic treatment can promote antimicrobial resistance and can contribute to the onward transmission of the untreated infection.
The CLIA waived status allows for expansion by permitting the binx io, through its national commercial distribution partnership with McKesson, to be placed in the over 220,000 CLIA-waived locations nationwide.
About the binx health io Instrument and CT/NG Assay: Key Features
- Intended for use in CLIA-waived, near-patient and point-of-care or clinical laboratory settings
- The io instrument processes a single-use, CT/NG cartridge that contains all reagents for testing self- or clinician-collected vaginal swabs and male urine samples. No sample preparation is required.
- Proprietary highly sensitive electrochemical detection technology
- Intuitive touch-screen operation with easy-to-follow screen prompts to start the fully automated test—no further user interaction is required
- Qualitative, easy-to-understand results with no interpretation required
- No instrument calibration or preventive maintenance required
binx health is a first-of-kind population health technology company that brings high quality convenient testing to the places where people live, work, study and shop. The Company works with large corporate partners and institutions to keep millions of people healthy and businesses and schools open. Its point-of-care io platform puts central-lab quality testing solutions in the hands of clinicians everywhere. This includes the rapidly expanding ecosystem of retail health and the Company’s suite of medically guideline-driven, at-home sample collection offerings which bring high quality testing and population health tools and digital integration capability to large corporate partners and those unable to visit a clinic location.
binx’ FDA-cleared io platform is the first ever point-of-care tool for the detection of chlamydia and gonorrhea that provides central lab performance results in about thirty minutes. Its platform is highly flexible, easy-to-use, and rapid, offering molecular point-of-care answers at central-lab quality performance and for the first time enabling single-visit test and treatment. The Company is currently expanding its platform into COVID-19 testing by combining our proprietary electrochemical detection with CRISPR methods. We are building solutions designed for the future of healthcare that lies at the nexus of testing convenience, rigorous science, and strong consumer relationships.
binx health Contacts
Media: Paul Kidwell
Stern Investor Relations, Inc.
5 Am J Emerg Med. 2015 Sep;33(9):1265-8