Medical Device Network

Visby Medical launches gonorrhoea test with antimicrobial resistance check

The test, designed to identify if the user’s gonorrhoea is susceptible to antibiotics, was launched in collaboration with a US non-profit aiming to cut the threat of antibiotic resistant bacteria.

A US sexual health diagnostic firm, Visby Medical, has been granted $1.8m to develop a portable rapid diagnostic for gonorrhoea that includes tests for antibiotic susceptibility.

The Boston-based company was awarded the money by the US non-profit organisation, Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) to develop the portable rapid polymerase chain reaction (PCR) diagnostic to detect the presence of the pathogen that causes gonorrhea, Neisseria gonorrhoeae, as well as its susceptibility to ciprofloxacin, an antibiotic that some forms of gonorrhea have developed a resistance to.

Visby Medical has said that as well as developing the gonorrhoea test, the investment from CARB-X will also be used to developa test for Neisseria gonorrhoeae, Chlamydia trachomatis (CT),and Trichomonas vaginalis (TV) in men based on urine samples.

Currently, Visby Medical has seen success on the market with its US Food and Drug Administration (FDA) 510(k) cleared second-generation sexual health test designed for the three most common sexually transmitted infections affecting women across the US. Now, Visby Medical is moving into STI testing for the male market.

Gary Schoolnik, chief medical officer of Visby Medical, said: “The sexually transmitted infections epidemic continues to increase. That is why healthcare providers in ERs, urgent care clinics, community health centres 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.

“The CARB-X award will allow Visby Medical to enhance the only instrument-free PCR platform by adding the capacity to detect ciprofloxacin-resistant gonorrhoea immediately and at the point-of-care. This has the potential to redefine best practice for patient care, infection control, and antibiotic stewardship.”

The World Health Organization describes gonorrhoea as the second most reported bacterial STI in the world, with as many as 82 million people globally thought to be infected with the condition in 2020. If left untreated, gonorrhoea can spread to the bloodstream, which can be life-threatening.

At the same time, a study published in The Lancet found that an estimated 1.27 million people died due to drug-resistant bacterial infections in 2019, a death toll that exceeded both HIV and AIDS (864,000) and malaria (643,000) in that same year.

The growing concern of Antimicrobial Resistance (AMR) has driven a number of changes and initiatives across the healthcare industry. At the 2024 World Economic Forum in Davos, Severin Schwan, chairman of the board of directors for Swiss medical device giant, Roche, called for more incentives to drive development of new antimicrobials.