FDA Approves First At-Home Test for Three Common STIs—Here’s What You Need to Know

If you’ve ever hesitated to get tested for sexually transmitted infections (STIs) because of the inconvenience, cost, or uncomfortable feeling of visiting a clinic, you’re not alone. But now, thanks to a groundbreaking decision by the U.S. Food and Drug Administration (FDA), those barriers might be a thing of the past.

The FDA has officially approved the first-ever at-home diagnostic test for three common STIs—chlamydia, gonorrhea, and trichomoniasis. Developed by Visby Medical, this test doesn’t just allow you to collect a sample at home—it delivers results in under 30 minutes without needing a prescription or mailing your sample. Here’s why this innovation is a game-changer for sexual health.

What Is the Visby Medical At-Home STI Test?

The Visby Medical Women’s Sexual Health Test is a handheld, single-use device designed specifically for people with vaginas. It tests for three of the most prevalent STIs in the United States:

• Chlamydia

• Gonorrhea

• Trichomoniasis

Using the test is simple: you collect a vaginal swab yourself, insert it into the device, and let the machine do its work. Results are delivered securely via the Visby app in about 30 minutes.

How Accurate Is It?

Accuracy is critical and one of the standout features of this test—it’s not just convenient; it’s reliable. Clinical trials showed impressive performance in both symptomatic and asymptomatic individuals:

• Chlamydia (chlamydia trachomatis): Correctly identified 97.2% of positive samples and 98.8% of negative samples.

• Gonorrhea (neisseria gonorrhoeae): Achieved perfect accuracy for positive samples (100%) and correctly identified 99.1% of negative samples.

• Trichomonas (trichomonas vaginalis): Correctly identified 97.8% of positive samples and 98.5% of negative samples.

These results demonstrate that the Visby test performs on par with laboratory-based PCR diagnostics, making it a trustworthy option for home use.

Why Is This Test a Big Deal?

The approval of this test addresses several challenges that have historically held back STI testing:

• Privacy: Many people avoid STI testing due to fear of judgment or stigma at clinics. Testing at home eliminates this concern.

• Convenience: With no need for prescriptions or appointments, users can test anytime, anywhere.

• Speed: Results are available within minutes on the app, enabling quicker diagnosis and treatment.

This innovation also normalizes STI testing as part of routine healthcare, much like checking your blood pressure or getting vaccinated.

What Should You Do With Your Results?

The next steps depend on your results:

• Positive Results: If you test positive for chlamydia, gonorrhea, or trichomoniasis, seek medical care promptly to begin treatment. All three infections are treatable with antibiotics when caught early.

• Negative Results: If your test is negative but you’re experiencing symptoms or suspect exposure to an STI, consult a healthcare provider for further evaluation.

While highly accurate, no diagnostic test is entirely foolproof—false positives or negatives can occur. Always follow up with a professional if you have concerns.

STI Rates Are Rising—Why Testing Matters More Than Ever

Sexually transmitted infections are very common in the U.S.  According to the CDC, 2.2 million cases of chlamydia and gonorrhea were reported in 2023 alone. Trichomoniasis affects an estimated 2.6 million people annually but often goes undiagnosed due to lack of awareness.

Many STIs are asymptomatic, meaning regular testing is essential to detect infections early and prevent complications like infertility or pelvic inflammatory disease. The Visby test empowers individuals to take control of their sexual health without waiting weeks for results or facing logistical hurdles.

How This Stacks Up Against Other At-Home Testing Options

Until now, at-home STI testing typically involved ordering a kit online, collecting your sample, and mailing it to a lab—followed by days of waiting for results. While helpful and useful for some, these tests aren’t diagnostic at home; they still require confirmation from a healthcare provider if positive.

The Visby Medical Women’s Sexual Health Test changes that dynamic entirely by offering FDA-authorized diagnostic results directly from your home. This means users can trust their results as definitive while enjoying unparalleled convenience.

Final Thoughts

The FDA approval of Visby Medical’s at-home STI test represents a major leap forward in sexual health care. By combining this new technology with ease of use and privacy, it removes many barriers that have long discouraged people from getting tested.

For sexually active individuals, regular STI testing is one of the best ways to protect both personal health and health of your partners. With this device now available over-the-counter, there’s no reason not to make testing part of your routine—and take charge of your sexual health today!

Sources: