Transforming STI Care: The Impact of FDA-Approved At-Home Testing

Expanding Access to Testing and Treatment

The U.S. Food and Drug Administration has granted marketing authorization to Visby Medical for the Visby Medical Women's Sexual Health Test, the first diagnostic test for chlamydia, gonorrhea and trichomoniasis that can be purchased without a prescription and performed entirely at home. The test is intended for females with or without symptoms and delivers results in approximately 30 minutes.

According to an FDA official, "Expanding access to tests for sexually transmitted infections is an important step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection." The agency noted that home tests can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment.

The need for accessible testing is clear. According to the Centers for Disease Control and Prevention's Sexually Transmitted Infections (STI) Surveillance Report, more than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023. Additionally, it is estimated that trichomoniasis is the most prevalent nonviral STI worldwide, affecting approximately 2.6 million people in the U.S., and all three infections can be treated with antibiotics, but if left untreated, can cause serious health complications for patients, including infertility.

Influence of the COVID-19 Pandemic

The COVID-19 pandemic dramatically reshaped STI testing and access to sexual health services. The COVID-19 pandemic reduced the sexually transmitted infection (STI) testing volume due to social-distancing and stay-at-home orders, among other reasons, and these events highlighted previously known benefits of at-home STI self-testing or specimen self-collection and accelerated testing demand via telemedicine.

A survey of health department STD programs and clinics found that 83% of STD programs were deferring STD services, and that 60% of clinics were experiencing reduced capacity to treat STIs. COVID-19 has accelerated the evaluation and development of STI self-tests and specimen self-collection, with increased testing, convenience, and privacy as potential benefits that may enhance uptake and outlast the pandemic.

Visby's Three-in-One Test Details

The Visby Medical Women's Sexual Health Test is a single use, at home test, that includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to the Visby Medical App, which displays results when the test is complete. The palm-sized device uses PCR technology to deliver lab-quality results without requiring users to mail samples to a laboratory.

The test correctly identified 98.8% of negative Chlamydia trachomatis samples and 97.2% of positive samples in women with or without symptoms, and for Neisseria gonorrhoeae samples, these rates were 99.1% and 100%, respectively, and for Trichomonas vaginalis samples, they were 98.5% and 97.8%, respectively. These accuracy rates were demonstrated in a clinical study involving over 2,000 participants across 13 geographically diverse locations.

Decreasing STD Rates

Recent data suggests progress in controlling the STI epidemic. In 2024, more than 2.2 million cases of chlamydia, gonorrhea, and syphilis were reported, which represents a 9% decline in STI morbidity compared to 2023 (and the third consecutive year of decreases). Chlamydia cases declined for the second year in a row, down 8% since 2023, and gonorrhea cases declined for the third year in a row, down 10% since 2023.

Increased awareness of STIs, ongoing collective public health efforts for prevention and control, and increased use of innovations like STI self-tests, newer point-of-care tests, and doxycycline as post-exposure prophylaxis for some bacterial STIs (doxy PEP), make a difference.

Drawbacks and Cautions of At-Home Tests

While at-home testing offers significant benefits, it's not without limitations. Similar to other tests, the primary risks of the Visby Medical Women's Sexual Health Test include the chances of false positive and false negative results, with false negatives potentially delaying treatment and allowing the infection to spread to other individuals, while false positives may lead to unnecessary treatment or a delay in receiving the correct diagnosis.

Additionally, experts caution that declining case numbers could reflect reduced testing rather than true decreases in infection rates. Surveillance only counts the number of positive test results, and a decline in positive test results could simply reflect fewer being tested for STIs. This underscores the importance of maintaining regular screening practices and not relying solely on symptom-based testing.

The test is currently available only for females and tests for three specific infections, meaning individuals may still need additional testing for other STIs like HIV or syphilis through healthcare providers.

Sources:

1. https://apnews.com/article/stds-fda-test-gonorreah-drug-visby-infection-2ff8c2ce9c757a2ad9eb599b291587ef
2. https://www.fda.gov/news-events/press-announcements/fda-grants-marketing-authorization-first-home-test-chlamydia-gonorrhea-and-trichomoniasis