New At-Home Syphilis Test Has Potential to Save Lives and Money

Syphilis is a serious bacterial infection caused by Treponema pallidum,¹ and one of the most common sexually transmitted infections (STIs) in the US.^2-4 It is both treatable and curable, but there is potential for serious downstream health outcomes. These include a higher risk of acquiring HIV and other STIs (eg, gonorrhea and chlamydia), organ damage, miscarriage, infant death, and heart and blood vessel complications.^1,3,5,6

There are 4 types of syphilis: primary syphilis, secondary syphilis, latent syphilis, and congenital syphilis (mother-to-baby transmission through the placenta).¹ The infection is typically spread through sexual contact.

The lifetime cost to treat a syphilis infection is $1190, according to 2021 data from the CDC.⁷ However, such an amount is out of reach for many. That combined with the recent significant surge in cases of syphilis—they are now at a 70-year high, with a nearly 80% jump in syphilis overall and a 183% leap in congenital syphilis over the 4-year period from 2018 to 2022⁸—make the recent FDA approval of an at-home test that much more timely.^9,10

On Friday, August 16, the FDA authorized the First To Know Syphilis Test from NOWDiagnostics. With just a finger prick to draw a few drops of blood, the at-home test available over the counter is able to detect T pallidum within 15 minutes—no prescription needed. Positive results must be confirmed with a health care provider and to inform treatment.^9,10

The lifetime cost of treating a syphilis infection is estimated to be $1190, but access to testing is inadequate and unequal, particularly among vulnerable populations | Image Credit: stock.adobe.com

At a price tag of $29.98, acquiring the test is achievable; however, health insurance coverage of the test is not always a guarantee,¹¹ with such considerations as gender, risk factors, and pregnancy status having an impact on coverage of specific STI tests.¹² Other tests for syphilis are approved, but only health care providers can do them.¹³

With the ability of a syphilis infection to go undetected for years, this new testing route also has potential to head off the downstream health care costs mentioned above and increase access to equitable care for STI testing.

In a news release announcing the authorization, Rob Weigle, CEO of NOWDiagnostics, said, "Testing is one of the most important tools we have in preventing the spread of sexually transmitted infections, and for the first time ever, consumers now have a fast and simple syphilis test that can be performed in the privacy of one’s home, with a result in minutes.”¹⁴

To boost uptake, the company hopes to collaborate with federal agencies, state health officials, local health officials, and major retailers to provide the test for free. There are also plans to reach more vulnerable populations—those affected by social determinants of health such as housing instability and lack of adequate health care—through social media and targeted advertising.⁹

The primary treatment for syphilis is penicillin, but one form of this antibiotic from Pfizer has been in short supply for well over a year. When first announced, the pharma giant had hoped to see an uptick in inventory by the second half of 2024,¹⁵ but this deadline has now been pushed back to the fourth quarter of this year.⁹

Experts attribute the surge in syphilis cases to 3 primary causes⁹:

• Inadequate screening coverage
• Lack of funding at federal and local levels
• How COVID-19 affected STI clinic operation

The marketing authorization came down under the FDA’s de novo premarket review pathway and incorporated data from a clinical study of 1270 individuals who found the test easy to use. In addition, this trial demonstrated a 99.5% accuracy rate when identifying blood specimens that were negative for syphilis and a 93.4% accuracy rate for specimens that were positive for syphilis compared with 3 FDA lab-based tests.

Market availability, online and in brick-and-mortar stores, is predicted to be as early as September.⁹

References

1. Syphilis. World Health Organization. May 21, 2024. Accessed August 19, 2024. https://www.who.int/news-room/fact-sheets/detail/syphilis#:~:text=Without%20treatment%2C%20the%20tertiary%20phase,syphilis%20can%20also%20cause%20death

2. Murtha J. 8 common STDs: what you need to know. Pfizer. Accessed August 19, 2024. https://www.pfizer.com/news/articles/8_common_stds

3. Most common STDs for women and men. WebMD. March 3, 2024. Accessed August 19, 2024. https://www.webmd.com/sexual-conditions/most-common-stds-men-women

4. National overview of STIs, 2022. CDC. Updated January 30, 2024. Accessed August 19, 2024. https://www.cdc.gov/std/statistics/2022/overview.htm

5. Nelson R. Syphilis rates soar in the USA amid penicillin shortage. Lancet. 2023;402(10401):515. doi:10.1016/S0140-6736(23)01665-3

6. Syphilis. Mayo Clinic. July 20, 2024. Accessed August 19, 2024. https://www.mayoclinic.org/diseases-conditions/syphilis/symptoms-causes/syc-20351756

7. Chesson HW, Peterman TA. The estimated lifetime medical cost of syphilis in the United States. Sex Transm Dis. 2021;48(4):253-259. doi:10.1097/OLQ.0000000000001353

8. Sexually transmitted infections. CDC. Accessed August 19, 2024. https://www.cdc.gov/std/statistics/2022/default.htm#:~:text=In%202022%2C%20more%20than%202.5,from%20all%20STI%20prevention%20partners

9. Roubein R. FDA clears first at-home syphilis test amid surge in cases. Washington Post. August 16, 2024. Accessed August 19, 2024. https://www.washingtonpost.com/health/2024/08/16/syphilis-test-at-home/

10. FDA marketing authorization enables increased access to first step of syphilis diagnosis. News release. FDA; August 16, 2024. Accessed August 19, 2024. https://www.fda.gov/news-events/press-announcements/fda-marketing-authorization-enables-increased-access-first-step-syphilis-diagnosis

11. Jordan E. STD testing without insurance. Exposed. September 27, 2022. Accessed August 19, 2024. https://www.stdcheck.com/blog/std-testing-insurance/

12. Does health insurance cover sexual health services? Planned Parenthood. Accessed August 19, 2024. https://www.plannedparenthood.org/get-care/health-insurance/about-health-insurance/does-health-insurance-cover-sexual-health-services#:~:text=Testing%20for%20certain%20STDs%20%E2%80%94%20like,and%20if%20you're%20pregnant

13. Considerations for the implementation of point of care tests for syphilis. HHS. June 2024. Accessed August 19, 2024. https://www.hhs.gov/sites/default/files/nscss-considerations-for-the-implementation-of-syphilis-poc-tests.pdf

14. NOWDiagnostics First To Know syphilis test receives FDA de novo marketing authorization for over-the-counter use. News release. NOWDiagnostics; August 16, 2024. Accessed August 19, 2024. https://nowdx.com/blogs/news/nowdiagnostics-first-to-know%C2%AE-syphilis-test-receives-fda-de-novo-marketing-authorization-for-over-the-counter-use

15. Archie A. Pfizer warns of a looming penicillin supply shortage. NPR. June 16, 2023. Accessed August 19, 2024. https://www.npr.org/2023/06/16/1182626821/pfizer-penicillin-shortage#:~:text=Health-,Pfizer%20is%20facing%20a%20penicillin%20shortage%20that%20may%20stretch%20into,rates%20of%20syphilis%20since%202000