FDA Authorizes First At-Home Test for Chlamydia, Gonorrhea: What to Know

The Food and Drug Administration (FDA) recently approved the first at-home test for three common sexually transmitted infections and diseases that can be purchased without a prescription.

The FDA marketing authorization has been granted to the Visby Medical Women’s Sexual Health Test for chlamydia, gonorrhea, and trichomoniasis.

The test is designed for females with or without symptoms of these three infections. Results are delivered within 30 minutes.

Visby officials told Healthline they expect the new test to be available in a few months and will announce pricing then.

The Visby product is a single-use test that includes a collection kit (vaginal swab) and a powered testing device that communicates with the Visby Medical App. The app displays results when the test is complete.

FDA officials reported that in recent clinical studies the Visby at-home test correctly identified more than 98% of negative samples for the three STDs and more than 97% of positive samples.

The FDA reviewed the product under the agency’s De Novo premarket review pathway, which allows low-risk to moderate-risk devices to be approved quickly. This authorization also allows other devices to go through the FDA’s 510 (k) premarket notification process for quick approval by proving their similarity to the Visby product.

“This approval is not just a milestone for Visby Medical but marks a transformative moment in medical diagnostics,” said Adam de la Zerda, PhD, founder and chief executive officer of Visby Medical, in a press statement.

There are currently several at-home test kits available for use by men and women for syphilis, chlamydia, gonorrhea, and trichomoniasis.

These tests are specific to these individual infections and involve collecting blood and/or urine samples. The products include the Visby Medical Sexual Health Test, which lacks the app that the new product contains.

At-home testing for STIs can improve treatment

The Centers for Disease Control and Prevention (CDC) reports that there were 2.2 million cases of chlamydia and gonorrhea diagnosed in the United States in 2023.

The agency also noted that there were 2.6 million confirmed U.S. cases of trichomoniasis that year.

In its annual surveillance report released last year, the CDC also reported there were more than 200,000 cases of syphilis diagnosed in the U.S. in 2022, the highest number since 1950.

Experts say at-home tests are important because people with STIs need to seek medical treatment quickly. Antibiotics are effective in treating these infections, but untreated STIs may lead to serious health issues, including infertility.

They add that test accuracy is also important because a false negative result can delay treatment. A false positive result can lead to unnecessary treatments and a potential delay in correctly diagnosing another infection or disease.

“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,” said Courtney Lias, PhD, the director of the Office of In Vitro Diagnostic Devices in the FDA’s Center for Devices and Radiological Health, in an FDA press release.

“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.”

Lisa Valle, DO, OB-GYN and medical director of Oasis Women’s Sexual Function Center in Santa Monica, CA, said at-home kits have the ability to increase the number of people who test for STDs.

“More people are apt to test in the privacy of their homes,” Valle told Healthline.

She noted that increased testing can help reduce the spread of STDs and lead to earlier treatments.

She does caution, however, that a person can receive a positive result while alone in their home without anybody to talk to or counsel them.

“There are medical and emotional issues they could be dealing with without the help of a healthcare professional,” she said.

Valle added that there are potential issues for someone who receives a negative test result at home. They can be satisfied there isn’t anything wrong with them despite having symptoms and not getting tested for other illnesses or conditions.

What to know about chlamydia, gonorrhea, and trichomoniasis

A sexually transmitted infection (STI) is when a bacteria, virus, or parasite attacks the body. These infections, many times, don’t have symptoms.

Some — but not all — STIs can develop into a sexually transmitted disease (STD). These diseases do produce symptoms in many people.

All can be diagnosed with basic tests and treated with antibiotics.

Chlamydia is usually transmitted through oral, vaginal, or anal sex without a condom or other barrier protection.

Some people who have chlamydia don’t have symptoms. When symptoms do appear, they can include:

Gonorrhea can affect anybody, but it is most common among teens and young adults between the ages of 15 and 24.

It is also transmitted through oral, vaginal, and anal unprotected sex.

Symptoms usually appear 2 to 30 days after exposure. They include:

Trichomoniasis causes symptoms in only about 30% of people with the disease.

When symptoms do appear, they include:

Valle said it is that important people get tested either at home or in a medical facility if they develop these symptoms.

She recommends that people get tested before and after they get involved with a new romantic partner.

“Overall, testing does help decrease the spread of these diseases,” she said.