N. gonorrhoeae bacteria
Reported cases of sexually transmitted infections (STIs) in the United States have been increasing at an alarming rate in recent years. According to the Centers for Disease Control and Prevention, there were over 1.6 million cases of chlamydia, and over 600,000 cases of gonorrhea reported in 2023, and more than 2 million new cases of trichomoniasis in 2018. People infected with these STIs do not always have symptoms, which makes diagnosing them difficult.
NIAID supported a clinical study of the Visby Medical Sexual Health Test, a palm-sized, rapid point-of-care diagnostic that can detect all three of these infections in women using a self-collected vaginal swab. The Visby Medical Sexual Health Test is a highly sensitive, nucleic acid amplification-based PCR diagnostic that returns results in less than 30 minutes, allowing patients to receive an accurate diagnosis during their initial visit.
Another advantage of the Visby Medical Sexual Health Test is that a rapid diagnosis can help avoid inappropriate use of antibiotics. This is particularly important for gonorrhea, because the bacteria that causes the disease, Neisseria gonorrhoeae, has developed resistance to many of the antibiotics that are used to treat infection. Reducing the unnecessary use of antibiotics can help slow the emergence and spread of resistant bacteria.
The Visby Medical Sexual Health Test received 510(k) clearance and was granted a CLIA waiver from the Food and Drug Administration (FDA) on August 30, 2021. The CLIA waiver allows these commercially available tests to be administered in healthcare settings rather than being sent to a laboratory.
Visby Medical also developed a second device based on the platform of their Sexual Health Test, which determines the susceptibility of N. gonorrhoeae to the antibiotic ciprofloxacin. This diagnostic won the federal Antimicrobial Resistance Diagnostic Challenge in 2020. While not yet approved for general use, this device would allow for resistance-guided treatment of gonorrhea infections, helping to preserve frontline antibiotics.
In February 2024, Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced funding to Visby Medical to develop a portable rapid test for gonorrhea and susceptibility to ciprofloxacin. With CARB-X funding, Visby Medical is also developing a diagnostic that uses urine testing to detect gonorrhea chlamydia, and trichomoniasis in men.