The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced today that it will award biotechnology company Visby Medical of San Jose, California, up to $1.8 million to develop a portable polymerase chain reaction (PCR) test that can detect gonorrhea and assess its susceptibility to ciprofloxacin.
Although ciprofloxacin is no longer a recommended first-line antibiotic for infections caused by Neisseria gonorrhoeae because of resistance, some strains of the bacterium remain susceptible to the oral antibiotic. Knowing which infections are susceptible to ciprofloxacin at the point of care could enable clinicians to reserve ceftriaxone, which is the last remaining antibiotic that remains widely effective against N gonorrhoeae.
Gonorrhea is among the sexually transmitted infections (STIs) that have been consistently climbing in the United States and other parts of the world over the past several years, and is the second most common bacterial STI. In 2020, roughly 82 million people worldwide reported gonorrhea infections.
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.
Need for rapid, accurate tests
“The sexually transmitted infections epidemic continues to increase,” Gary Schoolnik, MD, chief medical officer of Visby Medical, said in a CARB-X press release. “That is why healthcare providers in [emergency departments], urgent care clinics, community health centers and physicians’ offices need accurate and rapid diagnostic tests to enable same-visit, data-driven treatment based on a test result that identifies the pathogen and its antibiotic susceptibility.”
CARB-X research and development chief Erin Duffy, PhD, said the PCR test should be “rapidly and highly deployable” in low-resource 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,” she said.
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.
The test is the fourth project, and the first diagnostic, to receive funding from CARB-X’s 2022-23 funding call. Since its launch in 2016, CARB-X has supported 95 research and development projects in 13 countries.