FDA has granted a CLIA waiver to Boston-based Binx Health 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,” says 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.
“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,” says Jeffrey Luber, Binx chief executive officer.
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. 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.
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
For more information, visit Binx io.