Health
First at-home syphilis antibody test gets FDA authorization as STD cases spike in US
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.”
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.
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A new report by the American Heart Association (AHA) included some troubling predictions for the future of women’s health.
The forecast, published in the journal Circulation on Wednesday, projected increases in various comorbidities in American females by 2050.
More than 59% of women were predicted to have high blood pressure, up from less than 49% currently.
The review also projected that more than 25% of women will have diabetes, compared to about 15% today, and more than 61% will have obesity, compared to 44% currently.
As a result of these risk factors, the prevalence of cardiovascular disease and stroke is expected to rise to 14.4% from 10.7%.
The prevalence of cardiovascular disease and stroke in women is expected to rise to 14.4% from 10.7% by 2050. (iStock)
Not all trends were negative, as unhealthy cholesterol prevalence is expected to drop to about 22% from more than 42% today, the report stated.
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Dr. Elizabeth Klodas, a cardiologist and founder of Step One Foods in Minnesota, commented on these “jarring findings.”
“The fact that on our current trajectory, cardiometabolic disease is projected to explode in women within one generation should be a huge wake-up call,” she told Fox News Digital.
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“Hypertension, diabetes, obesity — these are all major risk factors for heart disease, and we are already seeing what those risks are driving. Heart disease is the No. 1 killer of women, eclipsing all other causes of death, including breast cancer.”
Cardiovascular disease is the leading cause of death for women in the U.S. and around the world. (iStock)
Klodas warned that heart disease starts early, progresses “stealthily,” and can present “out of the blue in devastating ways.”
The AHA published another study on Thursday revealing one million hospitalizations, showing that heart attack deaths are climbing among adults below the age of 55.
The more alarming finding, according to Klodas, is that young women were found more likely to die after their first heart attack than men of the same age.
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“This is all especially tragic since heart disease is almost entirely preventable,” she said. “The earlier you start, the better.”
Children can show early evidence of plaque deposition in their arteries, which can be reversed through lifestyle changes if “undertaken early enough and aggressively enough,” according to the expert.
Moving more is one part of protecting a healthy heart, according to experts. (iStock)
Klodas suggested that rising heart conditions are associated with traditional risk factors, like smoking, high blood pressure, high cholesterol, diabetes, obesity and a sedentary lifestyle.
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Doctors are also seeing higher rates of preeclampsia, or high blood pressure during pregnancy, as well as gestational diabetes. Klodas noted that these are sex-specific risk factors that don’t typically contribute to complications until after menopause.
The best way to protect a healthy heart is to “do the basics,” Klodas recommended, including the following lifestyle habits.
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Klodas especially emphasized making improvements to diet, as the food people eat affects “every single risk factor that the AHA’s report highlights.”
“High blood pressure, high blood sugar, high cholesterol, excess weight – these are all conditions that are driven in part or in whole by food,” she said. “We eat multiple times every single day, which means what we eat has profound cumulative effects over time.”
“Even a small improvement in dietary intake, when maintained, can have a massive positive impact on health,” a doctor said. (iStock)
“Even a small improvement in dietary intake, when maintained, can have a massive positive impact on health.”
The doctor also recommends changing out a few snacks per day for healthier choices, which has been proven to “yield medication-level cholesterol reductions” in a month.
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“Keep up that small change and, over the course of a year, you could also lose 20 pounds and reduce your sodium intake enough to avoid blood pressure-lowering medications,” Klodas added.
“Women should not view the AHA report as inevitable. We have power over our health destinies. We just need to use it.”
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Nearsightedness (myopia) is skyrocketing globally, with nearly half of the world’s population expected to be myopic by 2050, according to the World Health Organization.
Heavy use of smartphones and other devices is associated with an 80% higher risk of myopia when combined with excessive computer use, but a new study suggests that dim indoor lighting could also be a factor.
For years, scientists have been puzzled by the different ways myopia is triggered. In lab settings, it can be induced by blurring vision or using different lenses. Conversely, it can be slowed by something as simple as spending time outdoors, research suggests.
Nearsightedness occurs when the eyeball grows too long from front to back, according to the American Optometric Association (AOA). This physical elongation causes light to focus in front of the retina rather than directly on it, making distant objects appear blurry.
The study suggests that myopia isn’t caused by the digital devices themselves, but by the low-light environments where they are typically used. (iStock)
Researchers at the State University of New York (SUNY) College of Optometry identified a potential specific trigger for this growth. When someone looks at a phone or a book up close, the pupil naturally constricts.
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“In bright outdoor light, the pupil constricts to protect the eye while still allowing ample light to reach the retina,” Urusha Maharjan, a SUNY Optometry doctoral student who conducted the study, said in a press release.
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“When people focus on close objects indoors, such as phones, tablets or books, the pupil can also constrict — not because of brightness, but to sharpen the image,” she went on. “In dim lighting, this combination may significantly reduce retinal illumination.”
High-intensity natural light prevents myopia because it provides enough retinal stimulation to override the “stop growing” signal, even when pupils are constricted. (iStock)
The hypothesis suggests that when the retina is deprived of light during extended close-up work, it sends a signal for the eye to grow.
In a dim environment, the narrowed pupil allows so little light through that the retinal activity isn’t strong enough to signal the eye to stop growing, the researchers found.
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In contrast, being outdoors provides light levels much brighter than indoors. This ensures that even when the pupil narrows to focus on a nearby object, the retina still receives a strong signal, maintaining healthy eye development.
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The team noted some limitations of the study, including the small subject group and the inability to directly measure internal lens changes, as the bright backgrounds used to mimic the outdoors made pupils too small for standard equipment.
Researchers believe that increasing indoor brightness during close-up work could be a simple, testable way to slow the global nearsightedness epidemic. (iStock)
“This is not a final answer,” Jose-Manuel Alonso, MD, PhD, SUNY distinguished professor and senior author of the study, said in the release.
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“But the study offers a testable hypothesis that reframes how visual habits, lighting and eye focusing interact.”
The study was published in the journal Cell Reports.
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