The first at-home syphilis test has been approved for sale in the US as the worsening epidemic and decades-long rise in cases continues.
The Food and Drug Administration granted approval Friday for a 15-minute test from NOWDiagnostics to be marketed in the US.
A box with one test of the over-the-counter First To Know Syphilis Test will cost $29.98 and will be available at major retailers in the fall, according to reports.
But the test is not enough to diagnose the sexually transmitted infection and should be followed by additional testing for confirmation, health officials warn.
Prior to the approval, there was no over-the-counter test for syphilis infection, the FDA said in a news release.
“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,” said Dr. Michelle Tarver, acting director of the FDA’s Center for Devices and Radiological Health.
“This can lead to increased lab testing to confirm diagnosis, which can result in increased treatment and reduction in the spread of infection,” she added.
The new test uses a drop of blood to offer early indication of syphilis instead of the previously necessary blood test or testing of fluid from a syphilis sore.
The Centers for Disease Control and Prevention has reported an 80 percent increase in syphilis cases between 2018 and 2022 — from 115,000 to more than 207,000.
In 2022, more than 2.5 million cases of syphilis, gonorrhea and chlamydia were reported in the US.
The National Syphilis and Congenital Syphilis Syndemic Federal Task Force was created by the Department of Health and Human Services earlier this year in response to the skyrocketing cases.
The at-home test is part of the department’s strategic plan, which aims to reverse the “dramatic rise” of STIs in the US.
If untreated, syphilis can seriously damage the heart and brain and can cause blindness, deafness and paralysis, according to the CDC.
When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues and infant death.
It is also passed through sexual contact and, in rare cases, through blood transfusions or organ transplants.
It can only be transmitted sexually in its early stages, around the first four months, but can be passed on to a fetus at any stage, experts say.
The alarming rise started in 2000 and was initially seen among gay men but has emerged to include heterosexuals who use drugs. There has also been a rise among women.
Rates are highest among Black and American Indian populations, according to John Hopkins University.
Inadequate testing and a persistent stigma have hindered progress to beat the infection, public health officials say.
People are also using condoms less frequently, Dr. Nima Majlesi, director of medical toxicology at Staten Island University Hospital, told The Post in January.
The disease has also been unrecognized by doctors as it has become less common in recent decades.
In the 1990s, annual case counts dropped below 40,000.
