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Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award up to $1.8 million to biotechnology company, Visby Medical, to develop a portable rapid polymerase chain reaction (PCR) diagnostic to detect the presence of the pathogen that causes gonorrhea, Neisseria gonorrhoeae (NG), and its susceptibility to ciprofloxacin, a former frontline oral antibiotic that can no longer treat resistant NG. A rapid result on when ciprofloxacin may be effective could enable physicians to treat gonorrhea patients with confidence, while reserving ceftriaxone, the only antibiotic that remains effective against resistant NG.
Visby Medical is a leading innovator in rapid and accurate PCR testing for sexually transmitted infections (STIs) as well as COVID and the flu. The CARB-X award will help the company drive the next phase of development to meet the urgent challenges facing today's healthcare system.
In addition to the development of a rapid test for NG and susceptibility to ciprofloxacin, funding will support development of a test for NG as well as Chlamydia trachomatis (CT) and Trichomonas vaginalis (TV) in men based on urine samples. Currently, Visby Medical provides healthcare professionals with a second generation Sexual Health Test for the three most common STIs in women; the test is 510(k) cleared and has received a CLIA waiver from the U.S. Food and Drug Administration.
Additional CARB-X funding will be awarded in separate phases covering feasibility testing and development of both the antimicrobial resistance and male STI testing uses. Funding will be triggered by the completion of specific project goals. Visby Medical intends to supplement the CARB-X award with additional funding sources.
Gonorrhea is the second most reported bacterial STI. Approximately 82 million people were infected globally in 2020. Patients with gonorrhea can face serious health effects, including pelvic inflammatory disease, chronic pelvic pain, and infertility. If left untreated, gonorrhea can spread to the bloodstream, which can be life threatening, and increase the risk of HIV infection. Since patients do not always exhibit symptoms, reported cases may only capture a fraction of the true burden.
“Following a year-long funding call for diagnostics that aim to identify gonorrhea and determine its susceptibility to antibiotics, Visby Medical joins SpeeDx, making two diagnostic developers in the CARB-X portfolio that focus on this infection,” said Erin Duffy, PhD, R&D Chief of CARB-X. “Our goal is to deliver diagnostics that are effective at all levels of the healthcare system. Given the portability of the envisioned Visby Medical PCR platform, which fits in the palm of your hand, we see this as rapidly and highly deployable in low-resourced and hard-to-reach settings. Additionally, for regions where ciprofloxacin remains a viable treatment, the Visby Medical diagnostic gives confidence that the physician is making the correct treatment decision.”