Syphilis was nearly eliminated in the 1990s, but rates have since soared to a 70-year high.
By Rachel Roubein, The Washington Post
The Food and Drug Administration on Friday authorized the first at-home syphilis test amid surging cases of the bacterial infection and calls from federal health officials for innovative strategies to detect the disease.
The manufacturer, NowDiagnostics, anticipates the 15-minute test being available in pharmacies, major retail stores and online as early as September. FDA staff hailed the new product as an advancement in testing for sexually transmitted illnesses but noted that an additional test by a health-care provider is needed to confirm a positive result.
Syphilis was nearly eliminated in the 1990s, but rates have since soared to a 70-year high. Between 2018 and 2022, cases rose nearly 80 percent, according to the most recent data from the Centers for Disease Control and Prevention.
An at-home test “could allow more flexibility for people, so that they are able to access health care on their own terms and have more flexibility with how they’re being tested,” said Laura Bachmann, chief medical officer for the CDC’s Division of STD Prevention.
It’s an important tool for improving sexual health and decreasing STI rates, though it isn’t a replacement for recommended screenings, Bachmann said.
Company officials and public health advocates are hoping the option to take a test in the privacy of one’s home will serve as a critical new tool to boost testing for syphilis, particularly given the ongoing stigma attached to sexually transmitted infections. But getting the test to people most in need will be a challenge for the beleaguered public health system, raising concerns that only the most well-heeled will have easy access.
“The whole idea is to get more people tested,” Robert Weigle, CEO of NowDiagnostics, said in an interview. For the country to make strides in getting syphilis under control, he estimated tens of millions more people need to be tested.
Syphilis is a bacterial infection that primarily spreads through direct contact with a syphilis sore during vaginal, anal or oral sex. The infection can also be transmitted to a fetus during pregnancy, and cases of what’s commonly called congenital syphilis have spiked 183 percent from 2018 to 2022. The Department of Health and Human Services last year created a task force aimed at averting 5 percent of syphilis cases in newborns by next month.
The suggested retail price of the test will be $29.98. The company says it plans to work with federal agencies and state and local health officials to make the tests available at clinics and health departments at no cost.
“To be most equitable, we need resources in the public health system to distribute these tests for free,” said David Harvey, executive director of the National Coalition of STD Directors, a public health group representing health department STD directors. “Otherwise, we’re not going to reach those most in need.”
To use the tests, people will prick their finger to draw a drop of blood. Results from this test alone are not sufficient to diagnose syphilis, and more testing should be performed to confirm an infection, the FDA said.
Syphilis can easily go undetected.
The first clinical signs are usually ulcers at the site of the exposure, which are generally painless and, thus, can be easy to miss. Left untreated, the infection can cause serious health problems, such as fevers and skin rashes, and, in its later stages, heart and neurological problems.
The infection can be cured with antibiotics if caught early. Penicillin is the preferred treatment for patients in all stages of syphilis, but there’s a shortage of one form of the treatment, which is solely manufactured by Pfizer. There’s normal supply of a second formulation. The other version is expected to become more widely available in the last three months of this year, Pfizer said.
The recent rise in syphilis can be attributed to inadequate screening, a lack of robust funding at the federal and local levels, and the impact the coronavirus pandemic had on STI clinics, according to government officials and public health experts. Several tests are on the market — including two rapid tests boasting results within at least 15 minutes — but must be administered by a health-care professional.
The new test will substantially benefit people who are highly motivated and concerned about their sexual health, said Jeffrey Klausner, a clinical professor of medicine and public health at the Keck School of Medicine at the University of Southern California.
But it may not be a panacea for catching infections in the most vulnerable populations, such as people who are homeless or undocumented and who often go undiagnosed and untreated, said Klausner, formerly chief of STI prevention for San Francisco’s public health agency.
Weigle, of NowDiagnostics, acknowledged the difficulty, saying the company plans to use social media to get the word out about the test and to work with major retailers to create awareness inside stores and target such ads to pregnant women, men who have sex with men and others.
“It’s going to be a lot of work,” he said.
