The U.S. Food and Drug Administration has granted marketing authorization for the first at-home syphilis test.
The over-the-counter First To Know Syphilis Test, made by NOWDiagnostics in Arkansas, detects antibodies for Treponema pallidum (syphilis), according to a press release.
The test, which does not require a prescription, takes about 15 minutes to administer using only a drop of blood — “like a finger prick,” the company said.
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Results will be positive for those experiencing a current syphilis infection — as well as for those who have been previously diagnosed, even if they were successfully treated.
The test results are not sufficient to diagnose syphilis alone, however, and should be followed by additional testing from a provider to confirm the diagnosis, according to the FDA.
The First To Know Syphilis Test, pictured here, uses a blood sample to detect the infection. (NOWDx)
A clinical study of 1,270 people found the product “easy to use,” a press release from NOWDiagnostics noted.
The study results showed that the test correctly identified 99.5% of negative results and 93.4% of positive diagnoses.
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“With FDA authorization now granted, we are proud to offer the first test of its kind that provides highly accurate results in just minutes, using a single drop of blood and without the need for a buffer,” NOWDiagnostics CEO Rob Weigle told Fox News Digital via email.
“This breakthrough in diagnostic testing empowers individuals to take control of their health from the privacy of their own home, playing a critical role in early detection and treatment, and ultimately helping to slow the spread of syphilis and protect public health.”
“This is a great advance and has been vetted for accuracy,” one doctor commented. (NOWDx)
Fox News medical contributor Dr. Nicole Saphier said she considers at-home tests to be “great,” as they often lead to more people being tested who would not otherwise visit the doctor.
“Anything that increases access to health information while also being cost-effective is a positive step in the right direction,” the New York-based doctor told Fox News Digital.
Efforts to stop the surge
There has been a major rise in syphilis cases in the U.S. over the last few years.
Cases spiked by 80% between 2018 and 2022, according to data from the Centers for Disease Control and Prevention (CDC).
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In 2022, more than 3,700 cases of congenital syphilis were reported among newborns, the agency stated.
Earlier this year, the Department of Health and Human Services established the National Syphilis and Congenital Syphilis Syndemic (NSCSS) Federal Task Force to help combat the surging numbers.
Study results showed that the test correctly identified 99.5% of negative results and 93.4% of positive diagnoses. (iStock; NOWDx)
In addition to the task force, the FDA assured that the authorization of this new at-home test will help to “reverse the recent dramatic rise of STIs in the United States.”
“If left untreated, syphilis can seriously damage the heart and brain and can cause blindness, deafness and paralysis,” the FDA wrote in the press release.
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“When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues and infant death.”
Fox News senior medical analyst Dr. Marc Siegel told Fox News Digital that these advancements could also play into the CDC’s new program, DOXY PEP, which aims to prevent “post-exposure prophylaxis with doxycycline for chlamydia, gonorrhea and syphilis.”
“When transmitted during pregnancy, [syphilis] can cause miscarriage, lifelong medical issues and infant death.”
The program has been shown to “markedly decrease clinical infection,” said New York-based Siegel.
Siegel called the new syphilis test “especially important,” as “the earlier syphilis exposure/diagnosis is made the better.”
The authorization of the new at-home test will help to “reverse the recent dramatic rise of STIs in the United States,” the FDA stated. (iStock)
Michelle Tarver, M.D., PhD, acting director of the FDA’s Center for Devices and Radiological Health, wrote in a statement that advancements in tests for STIs can “give patients more information about their health from the privacy of their own home.”
“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,” she said.
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This can lead to increased lab testing to confirm the diagnosis, Tarver added, which can increase treatment and help curb the spread.
The FDA confirmed that false negative results may occur, which can cause delays in treatment and further spread of the infection. (iStock)
Saphier added that as syphilis cases rise, it’s “disappointing to see so many advanced cases of a disease that is otherwise treatable.”
“While prevention is always the best method, early detection and treatment intervention are essential to not only result in the best health outcome, but also decrease the overall cost burden on society — because advanced disease and disability are expensive,” she said.
Potential limitations
Saphier shared some concerns about using at-home tests in detecting illness, as they are “often lower in accuracy than standardized laboratory testing.”
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“This may result in false negative results and a person who otherwise may require treatment not seeking it,” she said.
“If someone is [at] high risk for syphilis exposure or having symptoms, they should skip the at-home testing and speak to their doctor.”
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The FDA confirmed that false negative results may occur, which could cause delays in treatment.
Congenital syphilis symptoms include sores and rashes on the skin, fever, jaundice, sneezing or runny nose and swollen spleen and liver, according to Mayo Clinic. (iStock)
“Results of the test alone should not be used to start, stop or change any treatments without a health care provider,” the FDA wrote in the press release.
“If someone is [at] high risk for syphilis exposure or having symptoms, they should skip the at-home testing and speak to their doctor.”
“In addition, individuals using this test who may have been recently exposed to syphilis should seek care from a health care provider for treatment and evaluation regardless of this test’s results.”
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Congenital syphilis symptoms include sores and rashes on the skin, fever, jaundice, sneezing or runny nose, and swollen spleen and liver, according to Mayo Clinic’s website.
If left untreated, later symptoms can include hearing loss, dental problems and “saddle nose,” a condition in which the bridge of the nose collapses.
