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Visby Medical Secures $1.8M From CARB-X for Gonorrhea and Drug Resistance MDx

NEW YORK – The global nonprofit organization Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, said on Thursday that it has awarded at least $1.8 million to Visby Medical for the development of a portable molecular test for the pathogen that causes gonorrhea and the susceptibility of that pathogen to a frontline antibiotic.

The organization said the money will be used to develop a portable, instrument-free, PCR-based diagnostic test to detect the presence of Neisseria gonorrhoeae and determine whether it is susceptible to the oral antibiotic ciprofloxacin. The results could help guide treatment of gonorrhea patients and aid stewardship of ceftriaxone, which is the only antimicrobial that remains effective against drug-resistant N. gonorrhoeae, the organization said.

"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," Erin Duffy, chief of R&D for CARB-X, said in a statement. "Additionally, for regions where ciprofloxacin remains a viable treatment, the Visby Medical diagnostic gives confidence that the physician is making the correct treatment decision."

Gary Schoolnik, chief medical officer for Visby, added that healthcare providers need accurate and rapid tests that identify the pathogen and its drug susceptibility.

Visby Medical will also use the money to support the development of a multiplex test for gonorrhea, chlamydia, and trichomoniasis in urine samples from male patients. The company already sells a test that is used for the detection of those infections in female patients using vaginal swab samples. The US Food and Drug Administration has granted 510(k) marketing clearance and a CLIA waiver for the latter test.

CARB-X said additional funding will be awarded following the completion of project goals, and that money will be used to support further test development and feasibility testing. The organization said that Visby Medical intends to supplement the awards with funding from additional sources.