Clinical laboratory news of the day – Portable rapid diagnostics using PCR can detect gonorrhea and antibiotic sensitivity – Microbiology

Portable rapid diagnostics using PCR will help identify gonorrhea and sensitivity to antibiotics

Author: LabMedica Editorial in Spanish
Updated February 29, 2024

Gonorrhea, the second most common bacterial sexually transmitted infection (STI), affected approximately 82 million people worldwide in 2020. This infection can lead to serious health complications, including pelvic inflammatory disease, chronic pelvic pain, and infertility. Untreated gonorrhea can progress into the bloodstream, creating a life-threatening risk and increasing the likelihood of contracting HIV. Many cases go unreported because patients are asymptomatic, meaning the actual disease burden may be significantly higher. Now the rapid test is aimed at identifying gonorrhea, as well as determining its sensitivity to antibiotics.

Visby Medical (San Jose, CA, USA) has received up to $1.8 million from CARB-X (Boston, MA, USA) to develop rapid, portable polymerase chain reaction (PCR) diagnostics to detect the presence of Neisseria gonorrhea

(NG), the causative agent of gonorrhea, and determine its sensitivity to ciprofloxacin. Ciprofloxacin was once the mainstay oral antibiotic for the treatment of NG, but has become less effective due to resistance. A quick result showing when ciprofloxacin may be effective will allow doctors to treat gonorrhea with greater confidence, reserving ceftriaxone for NG-resistant cases. Visby is known for its fast and accurate PCR testing capabilities for STIs, as well as COVID-19 and influenza. CARB-X funding will help Visby move to the next stage of development to address the pressing challenges of today’s healthcare system.

Wiz: Visby Medical Now Offers Second-Generation Sexual Health Tests to Screen for the Three Most Common STIs in Women (Photo courtesy of Visby)

In addition to developing a rapid test for NG and its sensitivity to ciprofloxacin, the funding will help Visby develop a test for NG and Chlamydia trachomatis (Connecticut) and Trichomonas vaginalis (TV) in men according to the results of a urine test. Visby currently offers a second-generation sexual health test for the three most common STIs in women, which is 510(k) approved and has received a CLIA waiver from the US Food and Drug Administration. Additional CARB-X funds will be awarded in increments based on achievement of specific project milestones, including feasibility studies and application development for antimicrobial resistance and STI testing in men.

“The epidemic of sexually transmitted infections continues to grow. That’s why healthcare providers in emergency departments, urgent care clinics, community health centers and doctors’ offices need fast, accurate diagnostic tests to provide data-informed care in a single visit, based on a single outcome. “The CARB-X award will allow Visby Medical to enhance its only instrument-free PCR platform by adding the ability to identify pathogens and their antibiotic susceptibility.” This has the potential to change best practices in patient care, infection control, and antibiotic stewardship. “Our goal is to provide diagnostics that are effective at all levels of the healthcare system,” added Erin Duffy, Ph.D., director of research and development at CARB-X: “Given the portability of the planned Visby Medical PCR platform, which fits in the palm of your hand, regions where ciprofloxacin remains a viable treatment option, Visby Medical’s diagnosis provides confidence that “the physician is making the right treatment decision.” “