CARB-X awards $1.8 million to Visby Medical to develop a portable rapid PCR test for gonorrhea

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Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), a biotechnology company, will award up to US$1.8 million to Visby Medical to develop a portable rapid polymerase chain reaction (PCR) diagnostic for the gonorrhea that causes it. Neisseria gonorrhea (NG), and its susceptibility to ciprofloxacin, a former frontline oral antibiotic that can no longer treat resistant NG. A quick result of when ciprofloxacin is effective could enable doctors to treat gonorrhea patients with confidence, saving 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 flu. The CARB-X award will help propel the company to the next stage of development to address urgent challenges facing today’s healthcare system.

In addition to the development of rapid tests for NG and sensitivity to ciprofloxacin, funding will support the development of a test for NG. Chlamydia trachomatis (City) and Trichomonas vaginalis (TV) based on male 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 has been 510(k) cleared and received a CLIA waiver from the US Food and Drug Administration.

Additional CARB-X funding will be awarded in separate phases covering both feasibility testing and development of antimicrobial resistance and use of male STI testing. Funding will begin upon meeting specific project goals. Visby Medical intends to supplement the CARB-X award with additional funding sources.

Gonorrhea is the second most commonly reported bacterial STI. An estimated 82 million people worldwide were infected in 2020. Patients with gonorrhea can face serious health consequences, including pelvic inflammatory disease, chronic pelvic pain, and infertility. If left untreated, gonorrhea can spread to the bloodstream, which can be life-threatening and increases the risk of HIV infection. Because 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 aimed at detecting gonorrhea and determining antibiotic susceptibility, Visby Medical joins SpeeDx, creating two diagnostic developers in the CARB-X portfolio that focus on this infection,” said Erin Duffy, PhD, CARB. -X’s R&D Chief. “Our mission is to provide effective diagnostics at all levels of the healthcare system. Given the portability of the envisioned VisB Medical PCR platform, which fits in the palm of your hand, we see it as fast and highly deployable in low-resource. and hard-to-reach settings. Additionally, In areas where ciprofloxacin remains an effective treatment, Visby Medical Diagnostics gives confidence that clinicians are making the right treatment decisions.”

The epidemic of sexually transmitted infections continues to grow. That’s why healthcare providers in ERs, urgent care clinics, community health centers and physicians’ offices need accurate and rapid diagnostic tests so that same-visit, data-driven treatment is based on a test result that identifies the pathogen and its antibiotic susceptibility. The CARB-X award will allow Visby Medical to enhance the only instrument-free PCR platform by adding the ability to detect ciprofloxacin-resistant gonorrhea immediately and at the point of care. It has the potential to redefine best practices for patient care, infection control and antibiotic stewardship.”

Gary Sculnick, MD, Chief Medical Officer of Visby Medicine

An estimated 1.27 million people died from drug-resistant bacterial infections in 2019, more deaths than HIV/AIDS (864,000) and malaria (643,000) combined in the same year. CARB-X is developing a pipeline of high-value products to prevent, diagnose and treat bacterial infections, which have become resistant to antibiotics. CARB-X emphasizes performance characteristics that will allow these products to be widely used against infections that drive optimal global morbidity and mortality.

When CARB-X was established in 2016, the early-stage antibiotic pipeline stalled. Since then, CARB-X has supported 95 R&D projects in 13 countries, and CARB-X product developers have made tremendous progress: 18 projects have advanced to or completed clinical trials; 12 are active in clinical development, including late-stage clinical trials; And two diagnostic products have reached the market. In addition, at least 9 product developers with active R&D projects have already secured advanced development partnerships that could support their clinical development after leaving the CARB-X portfolio.

In 2022, CARB-X launched new funding rounds to support research and development projects and fill critical gaps in the antibacterial pipeline. These include oral therapeutics to replace ineffective antibiotics; vaccines for neonatal sepsis, which kills 2.5 million babies a year; and oral therapeutics, vaccines and rapid diagnostics for gonorrhea. Visby Medical’s diagnostic is the first diagnostic and the fourth project to receive a CARB-X award as part of the 2022-2023 funding call. Additional projects are under review and new product developers will be announced this year. Register for the CARB-X newsletter to learn more about upcoming funding calls announced this year.

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