FDA approves at-home STD tests and new gonorrhea drugs as infection rates fall

The new tests and drugs expand options for patients reluctant to seek care in clinical settings, sexual health experts said, though higher price tags, lack of insurance coverage and recent federal funding cuts to public health agencies could limit access for the populations most in need.

The Food and Drug Administration last year cleared the first at-home test capable of detecting three sexually transmitted infections in women — gonorrhea, chlamydia and trichomoniasis — and approved two new drugs for gonorrhea, the first additions to that disease’s treatment options in decades. The agency also approved a home-based screening kit for HPV, the virus that causes cervical cancer. The advances arrive as CDC provisional data show 2024 marked a third consecutive year of declining gonorrhea cases in the United States.

Sexual health experts welcomed the new options while warning that higher price tags, lack of insurance coverage and recent federal funding cuts to public health agencies could limit access for the populations most in need.

New at-home tests cut turnaround to hours

Testing company Visby Medical launched its three-in-one STD test for women in 2025 following FDA approval in March. The test includes a vaginal testing swab and a small testing device; users upload a photo of the device and review results through a mobile app.

The $150 test is not covered by insurance. It also includes a telehealth consultation with a medical provider who can discuss results and prescribe antibiotics or other medication if needed. Dr. Gary Schoolnik, Visby’s chief medical officer and a professor emeritus at Stanford Medical School, said the full process from purchase to prescription can take as little as six hours, compared with several days under the traditional clinical testing model.

“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,” Schoolnik said.

The FDA based its approval on study results showing the test correctly detected all three infections with accuracy rates of around 98% or higher — comparable to tests performed at hospitals and health clinics, according to the company.

In May, the FDA also cleared Teal Health’s HPV testing kit. The company’s Teal Wand allows women to collect their own vaginal sample, which is placed in a tube and shipped to a laboratory for processing. Updated federal guidelines for HPV screening released in early January endorsed self-collection for the first time.

First new gonorrhea drugs in decades

The FDA ended 2025 by approving two oral drugs for gonorrhea. Both can be taken by mouth, a significant advantage over the current standard of care — an injection of the antibiotic ceftriaxone.

Nuzolvenc, developed through a public-private partnership, comes in granules that dissolve in water. Bluejepa, made by GlaxoSmithKline, is a tablet that is also approved to treat urinary tract infections.

The approvals come as gonorrhea has developed resistance to nearly every antibiotic used to treat it. The Centers for Disease Control and Prevention previously recommended an oral drug, azithromycin, alongside injectable ceftriaxone, but dropped the pill from its guidance after detecting signs of growing resistance.

“We were down to one class of antibiotics recommended to treat gonorrhea and we had no other good options,” said Dr. Ina Park, a sexual health specialist at the University of California, San Francisco. “So to have two new options in the same year is very exciting.”

STI rates declining, but access gaps loom

The new tools arrive alongside a downward trend in sexually transmitted infection rates. The CDC’s provisional data for 2024 showed a third consecutive year of fewer gonorrhea cases, and the second consecutive year of fewer adult chlamydia cases and the most infectious forms of syphilis.

Experts cited several factors behind the trend, including less sexual activity among young people, increased use of an antibiotic taken after sex to prevent infections and wider adoption of at-home screening.

That last factor also holds potential to reach patients who avoid clinical settings, Park said.

“Sexual health can be stigmatized and people can be hesitant about testing,” she said. “Now we have a lot of options for patients who may be wary of going into a provider’s office.”

Experts noted some caution alongside the optimism. As more people test at home, tracking national infection rates — historically compiled from a handful of large testing laboratories — could become more difficult. Higher prices add another barrier; Visby’s $150 test carries no insurance coverage. And recent Trump administration funding cuts to the CDC and other public health agencies compound the concern.

“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.”