Syphilis on the Rise: FDA Approves First At-Home Test
Syphilis on the Rise: FDA Approves First At-Home Test
What this breakthrough means for public health and personal testing
The media often frames sexually transmitted infections (STIs) in a negative light. Recent headlines highlight syphilis as a growing concern, even overshadowing potentially drug-resistant gonorrhea.
For the first time since 1950, rates of syphilis have increased in the U.S. The Centers for Disease Control and Prevention (CDC) reported 207,255 cases of syphilis in 2022, marking a 17.3% increase from 2021, and an 80% rise since 2018.
This week, the Federal Drug Administration (FDA) authorized the first over-the-counter, at-home test for syphilis. Priced at $29.98, it’s expected to be available this fall. Here’s what you need to know:
Understanding Syphilis
Syphilis is a bacterial STI that is preventable and curable, though often asymptomatic. Without treatment, it can lead to severe health problems.
Transmission: Via oral, anal, and vaginal sex; pregnancy; blood transfusions.
Symptoms: Vary by stage (Primary, Secondary, Latent, and Tertiary). You can learn more about each stage and symptoms here.
Can I pass syphilis to my baby? Yes, congenital syphilis occurs when people pass syphilis to their babies during pregnancy. It can lead to miscarriage, stillbirth, and additional health concerns. According to the CDC, 9 out of 10 (88%) cases could have been prevented in 2022. You can learn more about congenital syphilis and its impact here.
Are OTC tests for syphilis new?
While several companies offer at-home syphilis tests (including Everlywell, Let’sGetChecked, and Nurx), NOWDiagnostics’ test is the first to receive FDA authorization.
What does FDA authorization mean?
FDA authorization means, “…the product’s safety and effectiveness have been reviewed by the FDA and the product’s known and potential benefits outweigh the known and potential risks.”
Late last year, the FDA authorized the first at-home test for chlamydia and gonorrhea by Let’sGetChecked. Prior to this, the only other at-home collection kit available was for HIV.
Are non-FDA approved OTC tests bad?
Self-testing kits have been available for some time, with popularity increasing following the COVID-19 pandemic. FDA authorization offers a level of consumer protection, but STI self-test kits shouldn’t be dismissed, especially when considering understaffed clinics, access to care, and stigma around testing.
While the FDA encourages more companies to pursue approval for at-home tests, the cost of obtaining FDA approval can be a barrier, ranging from millions to billions of dollars depending on the product and market.
Why are rates of syphilis increasing?
Several factors contribute to increasing STI rates, including inadequate sex education, limited healthcare access, fear and stigma around testing, and underfunded health systems.
Dr. Ina Park’s recent New York Times essay, “How on Earth Is There a Syphilis Epidemic in 2024?” offers detailed insights into the current syphilis surge and historical context. Dr. Park emphasizes the rise in congenital syphilis cases and advocates for restored funding for public health clinics, enhanced education efforts, and increased staffing.
What populations are most impacted?
Men who have sex with men (MSM): The World Health Organization (WHO) estimates that “…an estimated 7.5% of gay men and other MSM have syphilis compared to 0.5% of men in the general population.”
Women of childbearing age: If you live in the U.S., you can see your county’s primary and secondary syphilis rates in this table.
Racial and ethnic minorities: Dr. Park notes that congenital syphilis cases are highest in Indigenous, Pacific Islander, and Black communities due to overlapping systemic issues.
Taking Action
Educate Yourself: Refresh your knowledge about STIs, including syphilis, to better understand potential outcomes and reframe your attitudes about STIs generally.
Get Tested: Since many syphilis infections present without symptoms, it’s important to stay updated on your STI screenings. If you’re unsure of a partner’s sexual health history or status, or are unsure of your own, getting tested at a clinic or at-home is a great first step.
Practice Safer Sex: Getting tested is only part of the equation. Be sure to communicate your status with your partners and use barriers, like internal and external condoms.
Raise Awareness: Open communication with your partners about sexual health is essential, but it’s important to extend these conversations beyond your relationships. Discussing sexual health with friends, especially if you’re all sexually active, can help raise awareness and create a supportive environment for accountability. Thpis transparency can further support safer sex practices and reduce stigma.
Advocate: While not everyone has unlimited time, there are small actions you can take within your community to advocate for increased program funding and sex education.
Vote: Research where candidates stand on important sexual health issues and vote accordingly.
Get Involved: Organizations like Guttmacher Institute and SIECUS: Sex Ed for Social Change offer resources on local policies and advocacy opportunities (no matter your availability).
While syphilis can be serious if left untreated, it’s manageable with awareness and proper care. By staying informed, practicing safer sex, and being proactive about our sexual health, we can collectively combat the rise in syphilis and foster a healthier community. Together, we can work toward a future where STI reduction and care are available to all, regardless of background or circumstance.
