The Visby Medical Women’s Sexual Health Test can screen for chlamydia, gonorrhea, and trichomoniasis.
Sexual transmitted infections (STIs) continue to be a public health concern. Along with millions of cases overall being diagnosed every year, attached to STIs is stigma and fear, which may prevent or delay people from getting tested. However, a new test looks to reduce these concerns by adding a layer of privacy with the ability to do an at-home test.
On Friday, the FDA granted marketing authorization to Visby Medical for the Visby Medical Women’s Sexual Health Test, which becomes the first diagnostic test for chlamydia, gonorrhea, and trichomoniasis that can be purchased without a prescription and performed at home.1 The test is designed for women, and is a single use test, that includes a collection kit (self-collected vaginal swab) and a powered testing device, which communicates securely to the Visby Medical App, and displays results when the test is complete. 1
“Home tests can give people information about their health from the privacy of their home. This can be particularly important for sexual health tests for which patients may experience fear or anxiety, possibly resulting in delayed diagnosis or treatment,” Courtney Lias, PhD, director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health, said in a statement. 1
All 3 infections can be treated with antibiotics, but if left untreated, can cause serious health complications for patients, including infertility.
The FDA has granted marketing authorization to Visby Medical for the first at-home diagnostic test for chlamydia, gonorrhea, and trichomoniasis.
STIs remain a serious public health issue, often accompanied by stigma and fear.
The test demonstrated high accuracy across all three infections, with over 97% sensitivity and specificity.
“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,” Lias said. 1
In individuals with and without symptoms, the test was shown to correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples, 99.1% of negative and 100% of positive Neisseria gonorrhoeae samples and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples. 1
FDA says that individuals with positive results for any of these infections should seek medical care. Individuals with symptoms, recent exposure to an STI or other concerns despite a negative result should contact their health care provider for additional testing. 1
As with many other tests, the risks associated with this test are mainly the possibility of false positive and false negative test results. False negative test results can result in delays to effective treatment and spread of infection to other persons. False positive results could lead to unnecessary treatment and/or a delay in receiving a correct diagnosis and appropriate treatment. 1
Overall, millions of these infections are diagnosed annually. More than 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the US in 2023 according to the National Overview of STIs in 2023, according to the Centers for Disease Control and Prevention (CDC).2 Included in these statistics are over 209,000 cases of syphilis, over 600,000 cases of gonorrhea, and over 1.6 million cases of chlamydia. Importantly, the combined count includes 3,882 cases of congenital syphilis, including 279 congenital syphilis stillbirths and neonatal/infant deaths. It’s estimated that trichomoniasis is the most prevalent nonviral STI worldwide, affecting approximately 2.6 million people in the US.2
CDC points out there was a decreased STI incidence rate of 1.8% from 2022 to 2023. For the individual STIs, it has been mixed results. 2
There was a decrease in gonorrhea (7.2%); stable trend in chlamydia (<1.0% change); and an increase in total syphilis (all stages and congenital syphilis combined) (1.0% increase).2
