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Investing.com -- The U.S. Food and Drug Administration (FDA) has granted marketing authorization to Visby Medical (TASE:BLWV) for its Women’s Sexual Health Test, the first home diagnostic test for chlamydia, gonorrhea, and trichomoniasis. The test, which can be purchased without a prescription and performed entirely at home, is designed for females, regardless of whether they are experiencing symptoms, and delivers results in approximately 30 minutes.
Courtney Lias, Ph.D., director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health, noted that home tests can provide individuals with health information from the privacy of their homes. This is especially important for sexual health tests, as patients may experience fear or anxiety, possibly leading to delayed diagnosis or treatment. Lias believes that expanding access to tests for sexually transmitted infections is a crucial step toward earlier and increased diagnosis, which can result in increased treatment and reduced spread of infection.
The Centers for Disease Control and Prevention’s Sexually Transmitted Infections (STI) Surveillance Report indicated that over 2.2 million cases of chlamydia and gonorrhea were diagnosed and reported in the U.S. in 2023. The CDC’s treatment guidelines also estimate that trichomoniasis is the most prevalent nonviral STI worldwide, affecting approximately 2.6 million people in the U.S. All three infections can typically be treated with antibiotics, but if left untreated, they can cause serious health complications, including infertility.
The Visby Medical Women’s Sexual Health Test is a single use, at-home test, that includes a collection kit and a powered testing device, which communicates securely to the Visby Medical App, displaying results when the test is complete. The test 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 in individuals with and without symptoms.
The FDA advises individuals with positive results for any of the three infections to seek medical care. Those with symptoms, recent exposure to an STI, or other concerns despite a negative result should contact their health care provider for additional testing. The risks associated with this test mainly include the possibility of false positive and false negative test results. False negative results can lead to delays in effective treatment and the spread of infection to others, while false positive results could lead to unnecessary treatment and/or a delay in receiving a correct diagnosis and appropriate treatment.
The FDA reviewed this test under the FDA’s De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. With this De Novo authorization, the FDA is establishing special controls related to labeling and performance testing. This action creates a new regulatory classification, allowing subsequent devices of the same type with the same intended use to potentially go through FDA’s 510(k) premarket notification process, which may save a developer time and expense compared to other review pathways.
This authorization follows last year’s authorization of the first at-home syphilis test, as well as the authorization of the first diagnostic test for chlamydia and gonorrhea with at-home sample collection in 2023. Other well-known companies offering at-home STD testing kits include myLAB Box, Everlywell, Let’s Get Checked, Nurx, and CVS.
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