FDA approves over-the-counter syphilis test amid national and Spokane County surge

Amid a local and national surge of syphilis, the U.S. Food and Drug Administration this month approved an over-the-counter test for the sexually transmitted infection.

While some may believe it is a disease of the past, syphilis is more prevalent in the United States than any time since the 1950s. Between 2018 and 2022, cases of the disease rose by more than 80% across the country, according to the CDC. In Spokane County, cases of syphilis rose last year to the highest level seen in at least two decades, Spokane County Regional disease investigation specialist Kirsten Duncan said.

Syphilis is a bacterial infection that can be spread whenever sexual contact occurs. The disease can have serious long-term health impacts if untreated. Individuals with the disease can be cured from it through a course of penicillin.

Last week, the FDA approved the first at-home, over-the-counter test to detect syphilis in human blood. Completed in 15 minutes, the “First To Know Syphilis Test” works with a pinprick of blood.

“We continue to see advancements in tests, particularly tests for sexually transmitted infections, which can give patients more information about their health from the privacy of their own home,” said Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health, in a statement.

Last year, the FDA similarly approved an at-home over-the-counter test for chlamydia and gonorrhea.

Celebrating the approval of their company’s product, NOWDiagnostics CEO Rob Weigle said in a prepared statement that the test will increase the pace of slowed efforts to combat the increasingly prevalent disease.

“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,” Weigle said.

According to a NOWDiagnostics spokesperson, the tests will be sold at the retail price of $29.98.

The at-home test does not preclude the need for further confirmation of syphilis. Should it be positive, those taking the test should see their doctor for a second opinion and treatment.

The at-home tests recently approved and the usual tests done by a medical provider with a blood draw can have false negatives. It typically takes 90 days from the point of exposure before a patient is more likely to test positive, Duncan said.

The FDA indicated the at-home test may be helpful to those who believe they may have been exposed to syphilis but feel embarrassment over a sexually transmitted infection.

“Access to home tests may help increase initial screening for syphilis, including in individuals who may be reluctant to see their health care provider about possible sexually transmitted infection exposure. This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection,” Tarver said in a statement.

That is a relevant concern for many patients in Spokane who may consider having an STI a moral failing even when their physician does not, Duncan said.

“There can be a lot of fear around going to a health care provider and saying that you think you might have been exposed. And so having this option to do this at home can be a great option and feel like lower stakes for people,” she said.

Syphilis tests are generally available at low cost with insurance, she added. The Spokane Regional Health District can conduct syphilis tests for those uninsured or otherwise unable to receive a test through their primary care physician. This service is prioritized for those who may be at a higher risk for the disease, such as drug users and those without housing.

A sign to look out for indicating you may need a test are open sores where sexual contacts occurs. Other symptoms include a nonitchy rash on your stomach, arms, feet or legs and a wart-like growth in the genital area.

The most important sign is when these symptoms do not go away and continue to persist for months at a time.

“It’s usually there for three to six weeks, and so if you have this open sore that’s not getting better, that’s a really good time to go in and get tested for syphilis,” Duncan said.

Syphilis in Spokane

Before 2016, few individuals in the Spokane area were infected by the sexually transmitted disease. But the disease has seen a precipitous rise in recent years – from 59 cases in 2015 to 379 cases in 2023.

Last year is the highest number of cases on record, according to the health district and a 60% increase in infectious cases from 2022. Syphilis cases this year remain high but at a similar pace to those seen last year, Duncan said.

For much of syphilis’ rise of the past decade, Spokane County has led the state in diagnosed cases. But in recent years, other areas of Washington have had higher rates of syphilis transmission.

While case rates were rising in Spokane, there were 9.2 syphilis cases per 100,000 residents statewide in 2017, according to a 2021 report from the Washington State Department of Health. That number remained relatively constant through 2020 until statewide figures jumped to 19.2 cases per 100,000 in 2021 – compared to just 10.9 per 100,000 a year earlier.

Guidance on syphilis from the Centers for Disease Control and Prevention recommends that men who have sex with men get tested for syphilis annually or up to every three months, depending on their risk factors. In 2021, the Spokane Regional Health District changed its local recommendation, urging all sexually active, nonmonogamous individuals be tested annually – in part because of a rise in cases among those who engage in unprotected heterosexual sex.

The health district is paying closest attention to the rise of congenital syphilis, which is spread from a pregnant person to their fetus. While adults can be treated for syphilis, the disease causes stillbirth or miscarriage in a fifth of cases and there is an additional 9% chance that the infant will die within the first month of their life. Children who survive are at risk of long-lasting symptoms.

The number of congenital cases of syphilis has tripled from 2022 to 2023, Duncan said.

Earlier this year, the health district put up a number of billboards across the city to raise awareness about syphilis, especially among those who are or could become pregnant.

“Syphilis could harm your baby,” reads one of the billboards.

“Your rash and sore might be syphilis,” reads another.

Health district spokesperson Kelli Hawkins said the billboards “caused a lot of discussion” and reaction to them was “decidedly mixed.”

“It made us happy that it got people talking, because that’s what they were meant to do,” Hawkins said.

Duncan said the awareness from the signs was needed because many at risk in Spokane do not believe syphilis is a threat to them.

“The data is really showing that syphilis is impacting everyone across the board in Spokane who is sexually active,” she said. “But we were hearing from our health care providers that they would offer a test and the patient would decline because they don’t think its a concern, it’s something that’s not around anymore. And that is the furthest from the truth.”