At a Glance
- The FDA has authorized the first at-home test that detects gonorrhea, chlamydia and trichomoniasis in women.
- Two new oral gonorrhea drugs-Nuzolvenc and Bluejepa-arrived after decades with no new options.
- Visby Medical’s $150 kit delivers results and telehealth prescriptions within six hours.
- Why it matters: Faster, private testing and new antibiotics could accelerate recent declines in U.S. STD rates.
The Food and Drug Administration has cleared the first home-testing kits for several common sexually transmitted infections and approved two new oral drugs for drug-resistant gonorrhea, offering patients faster diagnosis and treatment without clinic visits.
Home testing kits hit the market
Last March, the FDA approved Visby Medical’s three-in-one urine-based kit for women. The package contains a vaginal swab and a pocket-sized device that processes the sample and transmits results to a smartphone app. A telehealth consultation is included; if the test is positive, a clinician can prescribe antibiotics during the same session.
Dr. Gary Schoolnik, Visby’s chief medical officer and a Stanford professor emeritus, says the end-to-end process can shrink from several days to six hours. Company data submitted to regulators showed accuracy rates of roughly 98 percent for each infection, on par with hospital labs.
Teal Health received separate clearance in May for a self-collection kit that detects human papillomavirus, the primary cause of cervical cancer. Women use the Teal Wand to collect a vaginal sample, mail it to a lab and receive results online. Federal screening guidelines updated earlier this month endorsed HPV self-collection for the first time.
First new gonorrhea drugs in decades
The bacterium that causes gonorrhea has outlasted nearly every antibiotic used against it. Until recently, the only recommended therapy was an injection of ceftriaxone plus, formerly, an oral azithromycin pill that the CDC withdrew after resistance emerged.
In late 2024, the FDA cleared two oral medications:
| Drug | Maker | Form | Also approved for |
|---|---|---|---|
| Nuzolvenc | Public-private partnership | Granules dissolved in water | – |
| Bluejepa | GlaxoSmithKline | Tablet | Urinary-tract infections |
Both drugs arrived in the same year, ending a decades-long drought. “We were down to one class of antibiotics recommended to treat gonorrhea and we had no other good options,” said Dr. Ina Park, a University of California, San Francisco, sexual-health specialist. “So to have two new options in the same year is very exciting.”
Cases are falling
The Centers for Disease Control and Prevention’s provisional 2024 data show:
- Gonorrhea cases down for a third straight year
- Adult chlamydia infections lower for the second consecutive year
- The most infectious stages of syphilis also declined
Experts credit multiple factors:
- Reduced sexual activity among young people
- Wider use of the morning-after antibiotic doxycycline to prevent bacterial STDs
- Expanded at-home screening
Access hurdles remain
Visby’s kit costs $150 and is not covered by insurance, a price that could deter widespread adoption. As more consumers test at home, national surveillance may lose the detailed reporting that large commercial labs once provided.
Dr. Park welcomed the new tools but warned that recent federal funding cuts to the CDC and other public-health agencies could limit outreach to low-income populations. “I’m feeling very optimistic about the fact that people have more testing options and also that we now have access to new drugs,” she 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.”
Key takeaways
- Women can now test themselves at home for three common STDs and HPV
- Two new oral antibiotics offer fresh weapons against drug-resistant gonorrhea
- Faster diagnosis and treatment may help sustain recent declines in infection rates
- High out-of-pocket costs and possible surveillance gaps could blunt the impact
