Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), the nonprofit partnership supporting research and development to address the rising threat of drug-resistant bacteria, announced that it will award up to $1.8 million to biotech firm Visby Medical to develop a portable rapid polymerase chain reaction (PCR) test to detect Neisseria gonorrhoeae, the pathogen that causes gonorrhea, including its susceptibility to ciprofloxacin.
Ciprofloxacin is a former first-line treatment to which some strains of gonorrhea have become drug resistant. Rapid testing for ciprofloxacin resistance would enable doctors to treat patients effectively, using ciprofloxacin for nonresistant cases and reserving ceftriaxone, the sole antibiotic still effective against drug-resistant gonorrhea, for resistant cases.
Cases of gonorrhea and other sexually transmitted infections (STIs) have reached unusually high numbers in recent years. Approximately half of all gonorrhea infections in the U.S. in 2022 were drug resistant, according to the U.S. Centers for Disease Control and Prevention 2022 STI Surveillance Report.
San Jose, CA-based Visby Medical develops and manufactures rapid PCR tests for STIs, as well as tests for COVID-19 and influenza. The firm’s sexual health test is a handheld all-in-one PCR test unit that can deliver results for N. gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis infections in women in under 30 minutes; the test is 510(k) cleared and has received a CLIA waiver.
Visby will also use the funding to develop a urine-based test for N. gonorrhoeae, C. trachomatis, and T. vaginalis in men.
Additional CARB-X funding will be awarded in separate phases to cover feasibility testing and the development of both the drug-resistance detection and the male STI test, with funding released at the completion of specific project goals.