New options for testing and treating some of the most common sexually transmitted diseases are becoming available, a trend that experts hope will keep downward pressure on U.S. infection rates.
Last year, the Food and Drug Administration approved the first at-home test that can detect three common infections in women — gonorrhea, chlamydia and trichomoniasis — as well as the first home-based kit for the virus that causes cervical cancer.
The agency ended the year by approving two different drugs for gonorrhea, the first new options for the disease in decades.
It’s positive news after cases of sexually transmitted infections reached alarming highs before and during the COVID-19 pandemic, which disrupted screening, education and treatment for sexual health nationwide.
But the pandemic years also brought positive developments for testing. The same technology used for the first over-the-counter coronavirus tests is now being translated into home-based kits for syphilis and other sexually transmitted infections. Previously, the FDA had mostly limited the use of such tests to health professionals.
“Sexual health can be stigmatized and people can be hesitant about testing,” said Dr. Ina Park, a sexual health specialist at the University of California, San Francisco. “Now we have a lot of options for patients who may be wary of going into a provider’s office.”
New Tests Offer Convenience and Quicker Turnaround Times
Testing company Visby Medical launched its three-in-one test for women last year, following FDA approval in March. The test includes a vaginal testing swab and a small testing device that uses PCR technology — the same type used in lab testing — to detect gonorrhea, chlamydia and trichomoniasis. After uploading a photo of the device, users can review the results through a mobile app.
The Visby test costs about $150 and includes a telehealth consultation with a medical provider who can discuss results and prescribe antibiotics or other medication if needed. The test is not currently covered by insurance.
The entire process — from buying the test to getting a prescription — can take as little as six hours, compared with several days under the traditional testing model, said Dr. Gary Schoolnik, Visby’s chief medical officer.
Previously, a nurse or doctor would have to collect a sample, send it to a lab, receive results and schedule a follow-up visit.
“Many patients are very hard to track down, and a lot of them, if they have a positive test result, are never treated and are lost to follow-up,” said Schoolnik, who is also a professor emeritus at Stanford Medical School.
The FDA approved Visby’s test based on studies showing accuracy rates around 98% or higher, comparable to tests performed in hospitals and clinics.
A Growing Range of Home Tests — With Varying Costs
Visby’s test is among the most advanced, but it is not the only at-home option now available.
Several other home-based STD tests require users to collect samples at home and mail them to a laboratory for analysis. These tests typically screen for infections such as chlamydia, gonorrhea, trichomoniasis, HIV and syphilis, depending on the kit.
Prices vary widely. Basic mail-in tests that screen for one or two infections can cost $40 to $100, while mid-range panels that test for multiple STDs generally range from $100 to $200. Comprehensive panels that test for a broader list of infections can exceed $300. Many of these tests accept HSA or FSA funds, but insurance coverage is inconsistent.
Some rapid tests sold online also screen for infections such as HIV or syphilis, but experts caution that not all over-the-counter products offer the same accuracy as FDA-authorized molecular tests.
HPV Testing Moves Closer to Home
Some home-based tests still require outside lab processing.
In May, the FDA approved Teal Health’s testing kit for HPV, the virus that causes cervical cancer. The company’s Teal Wand allows users to collect a vaginal sample at home and mail it to a lab for testing.
While Teal Health has not publicly released a standard retail price for the HPV kit, similar at-home cervical screening tests typically cost $100 to $250, with insurance sometimes reducing out-of-pocket costs.
Updated federal guidelines for HPV screening released earlier this month endorsed self-collection for the first time, a shift experts say could expand access for people who face barriers to in-office exams.
The FDA recently Approved the First New Gonorrhea Drugs in Decades
The bacteria that causes gonorrhea has continually evolved, developing resistance to nearly every antibiotic used to treat it.
Both of the two newly approved drugs can be taken by mouth — a major advantage over the current standard treatment, an injection of the antibiotic ceftriaxone.
Nuzolvenc, developed through a public-private partnership, comes in granules that dissolve in water. Bluejepa, from GlaxoSmithKline, is a tablet also approved to treat urinary tract infections.
The Centers for Disease Control and Prevention previously recommended pairing oral azithromycin with injectable ceftriaxone but dropped the pill after signs of rising resistance.
“We were down to one class of antibiotics recommended to treat gonorrhea, and we had no other good options,” Park said. “So to have two new options in the same year is very exciting.”
STD Rates are Falling Again — But Challenges Remain
The CDC’s provisional data for 2024 showed a third consecutive year of fewer gonorrhea cases, and a second year of declining adult cases of chlamydia and the most infectious forms of syphilis.
Experts point to several factors behind the trend, including reduced sexual activity among young people, increased use of antibiotics as post-exposure prevention and expanded access to at-home testing.
Still, some urge caution.
As more people test at home, it could become harder to track national infection rates, which historically have relied on reporting from major laboratories.
Cost remains another concern. Many of the newer tests and treatments carry higher price tags, potentially limiting access for uninsured and low-income patients.
Add to that recent funding cuts to the CDC and other public health agencies, and experts worry disparities could widen.
“I’m feeling very optimistic about the fact that people have more testing options and also that we now have access to new drugs,” Park said. “What I fear is these cuts to public health are going to decrease access to sexual health care for populations who can least afford to take advantage of these new options.”