binx Assay Development

The following assays are under development and designed to address important needs, but not yet available.

io mSTI

The binx health io mSTI (Multi-STI) is being developed to test for the causative organisms of the three most common sexually transmitted diseases: Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. Each of these three infections can have similar symptoms but require different treatment.

The io mSTI cartridge will enable the detection and identification of these three STI pathogens in about 30 minutes from a single patient specimen. The rapid turnaround with disease stratification will expedite targeted therapy, thereby reducing onward transmission and inappropriate empiric treatment, while improving antibiotic stewardship.

* FOR INVESTIGATIONAL USE ONLY. THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT HAVE NOT BEEN ESTABLISHED. NOT FOR SALE IN THE UNITED STATES.

io mSTI+

The binx health io mSTI+ (Multi-STI+) assay is being developed to test for four key causative organisms of sexually transmitted diseases: Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium, causing infection that can have either no or similar symptoms but require different treatments.

The io mSTI+ assay will enable rapid identification of these four STI pathogens from a single patient specimen to ensure accurate treatment in a single visit. The rapid turnaround with disease stratification will expedite targeted therapy, thereby reducing onward transmission and inappropriate empiric treatment, while improving antibiotic stewardship.

* FOR INVESTIGATIONAL USE ONLY. THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT HAVE NOT BEEN ESTABLISHED. NOT FOR SALE IN THE UNITED STATES.

io NG+R

The io NG+R assay is being developed to simultaneously detect the presence of Neisseria gonorrhoeae and mutations that confer fluoroquinolone resistance. Once highly treatable with several drugs, there are now widespread antimicrobial resistant strains of N. gonorrhoeae circulating which represent a growing and major challenge to the management and control of gonorrhoeae infection. The binx io NG+R will enable immediate and effective treatment of gonorrhea positive patients with the appropriate antibiotic, offering improved antibiotic stewardship and lowering treatment costs.

* FOR INVESTIGATIONAL USE ONLY. THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT HAVE NOT BEEN ESTABLISHED. NOT FOR SALE IN THE UNITED STATES.

io MG+R

The io MG+R assay is being developed to simultaneously detect the presence of Mycoplasma genitalium and mutations associated with macrolide resistance. Identification of infection and susceptibility will enable patients to receive rapid and effective treatments for M. genitalium infection, promote improved antibiotic stewardship and lower treatment costs.

* FOR INVESTIGATIONAL USE ONLY. THE PERFORMANCE CHARACTERISTICS OF THIS PRODUCT HAVE NOT BEEN ESTABLISHED. NOT FOR SALE IN THE UNITED STATES.

binx health announces second FDA 510(K) clearance of its molecular point-of-care infectious disease platform.

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