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).
SYPHILIS CASES SURGE IN THE US, REACHING LEVELS UNSEEN SINCE 1950
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.
Over the two and a half years following the 2022 rollout of the 988 national suicide prevention hotline, the rate of suicides among young people in the United States dropped 11 percent below projections, decreasing most sharply in states with a higher volume of answered 988 calls, a new study has found.
The findings, published today as a research letter in JAMA, compared suicide deaths from July 2022 to December 2024 with sophisticated mathematical projections that were based on historical trends. This yielded good news, with 4,372 fewer suicides of adolescents and young adults, ages 15 to 34, than had been projected.
To ensure that the decline was related to the use of the hotline, researchers at Harvard Medical School teased out the trends in states with high and low usage of the hotline. The findings were striking: The 10 states with the largest increases in 988 calls experienced an 18.2 percent reduction in observed suicides compared with expected suicides; in the 10 states with the lowest uptake, the reduction was smaller, 10.6 percent.
The results suggest that the government’s investment in the 988 rollout has translated into “a measurable reduction of deaths,” said Dr. Vishal Patel, a resident physician at Brigham and Women’s Hospital and one of the authors of the study.
“What our study has added,” he said, “is evidence for the deeper benefit of the program, and that is, that at the population level, among young people at least, suicide mortality is lower than it would have been without the program.”
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Are you concerned for your teen? If you worry that your teen might be experiencing depression or suicidal thoughts, there are a few things you can do to help. Dr. Christine Moutier, the chief medical officer of the American Foundation for Suicide Prevention, suggests these steps:
He added, “The implication of that is that sustained funding for this program matters.”
The United States rolled out the three-digit hotline with bipartisan support in July 2022, replacing a 10-digit hotline number, and augmented it with a $1.5 billion investment in crisis center capacity. Since its inception, the service has fielded more than 25 million contacts, according to the Department of Health and Human Services. The agency has asked Congress for $534.6 million to fund the program for 2027.
Last summer, the Trump administration terminated one element of the hotline, the Press 3 option for L.G.B.T.Q.+ callers. The Substance Abuse and Mental Health Services Administration said that the Press 3 option was being discontinued because it had exhausted its funding from Congress and that the hotline would “focus on serving all help seekers.”
But advocacy groups and policymakers protested the decision, and in testimony before the Senate on Tuesday, the health secretary, Robert F. Kennedy Jr., said his agency was planning to restore the Press 3 option.
Dr. Patel said his group had become curious about measuring the program’s effectiveness after Press 3 was eliminated. While call volume and satisfaction surveys suggested that 988 was succeeding, he said, the harder question was, “Did the creation of this 988 program, the transition from the old hotline to this hotline, actually move the needle on suicide mortality?”
Experts said it was difficult to tease out the beneficial effect of 988 from other things that changed in 2022, the year that the new hotline was created. Around that time, suicide prevention programs were being introduced in schools, in faith communities and on social media, but more important, the pandemic was ending.
“We were finally out of this crazy time, and there was a sense of optimism and hope,” said Jonathan B. Singer, a professor of social work at Loyola University Chicago and a co-author of “Suicide in Schools.” He called the downward trend in youth suicides “encouraging, but it is tempered by the fact that we don’t have a good explanation as to why.”
The authors acknowledged that their findings could not account for the influence of social and economic changes, changes in mental health services or public awareness about services.
But they did make comparisons to exclude other possible explanations. The authors looked for similar effects among American adults over 65, who are less likely to use the hotline. In that group, there was a reduction in suicides that exceeded expectations, but it was smaller, at just 4.5 percent.
To ensure the decline in suicides did not reflect a general improvement in young-adult mortality, the researchers tracked cancer deaths, and found there was no change. They also looked at the rates of suicide among young people in England, where no change had been made to the national crisis line in that time period; they found no reduction in youth suicides there.
Hannah Wesolowski, chief advocacy officer for the National Alliance on Mental Illness, said she was persuaded that the hotline had contributed to the improvement in suicide rates, in part because it did not appear among English youths or in older Americans.
“To me, that really helps hone in that this might really be the differentiator,” she said. “We are seeing potentially a pretty significant decline in suicides among young people. For public policy, this is strong evidence to double down on that we are doing.”
Emily Hilliard, a senior press secretary at the Department of Health and Human Services, said H.H.S. and SAMHSA are “committed to ensuring that all Americans have access” the 988 line, which she said “clearly provides lifesaving support, helping millions of people every year.”
If you are having thoughts of suicide, call or text 988 to reach the 988 Suicide and Crisis Lifeline or go to SpeakingOfSuicide.com/resources for a list of additional resources.
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A highly contagious digestive virus is surging across the U.S., experts warn.
Rotavirus, a double-stranded RNA virus, causes acute gastroenteritis — inflammation of the stomach and intestines — which can lead to severe diarrhea, vomiting, fever and stomach pain.
The virus primarily affects infants and young children, but there have also been outbreaks in elderly populations, such as nursing homes.
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Data from the Centers for Disease Control and Prevention shows that in the week ending April 4, out of 2,329 rotavirus tests, 7.3% were positive for the infection. Last year’s highest infection rate was 6.77% as of the week ending April 19.
Rotavirus, a double-stranded RNA virus, causes acute gastroenteritis — inflammation of the stomach and intestines — which can lead to severe diarrhea, vomiting, fever and stomach pain. (iStock)
“We’re seeing a lot of rotavirus in the wastewater right now,” Dr. Marc Siegel, Fox News senior medical analyst, confirmed to Fox News Digital. “Testing for rotavirus is way down, but the percentage of positive tests is up.”
While the virus typically peaks in the spring, it is not currently slowing down, he noted.
Why cases may be rising
Patricia Pinto-Garcia, M.D., a medical editor at GoodRx who is based in California, said there are several possible reasons for the rotavirus spike.
“Vaccine rates are down overall among young children, as they decreased during COVID,” she told Fox News Digital. “This means there’s a growing number of infants and young children who are vulnerable to infection.”
The rotavirus vaccine series must be completed by the time a child is 8 months old, she noted.
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As a result of the declining vaccinations, herd immunity isn’t protecting vulnerable children, according to Pinto-Garcia. “Children who haven’t finished the vaccine series yet, are too young to get vaccinated, or can’t get the vaccine due to medical illness are more likely to get exposed to the illness because other children aren’t vaccinated,” she said.
Siegel noted that before the vaccine became available, rotavirus resulted in 55,000 to 70,000 in the U.S. per year.
“Vaccine rates are down overall among young children, as they decreased during COVID,” a doctor told Fox News Digital. “This means there’s a growing number of infants and young children who are vulnerable to infection.” (iStock)
“I am concerned that the vaccination rate has been declining over the past seven years and is continuing to decline in the current climate of vaccine skepticism,” he said.
Surveillance methods are also much better than they used to be, Pinto-Garcia noted, which means public health experts are able to pick up and track cases better than ever before.
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“But we see that rotavirus-related healthcare visits are also up, so improved detection is not the only reason we are seeing this spike,” she said.
The COVID pandemic also disrupted the pattern of infections, according to Pinto-Garcia, so it’s “tricky” to compare the current levels against older cycles.
“It’s possible that what we are seeing is still some post-pandemic rebound, but it’s unlikely that this year’s pattern is fully explained by just this factor,” she added.
Transmission and risk
Dr. Zachary Hoy, a pediatric infectious disease specialist at Pediatrix Medical Group based in Nashville, Tennessee, often sees young patients with rotavirus.
“Rotavirus is spread via the fecal-oral route, meaning that a person comes into contact with virus droplets from contact with other children or adults, or from contact with objects such as toys that have been contaminated with the virus from someone who is sick,” he told Fox News Digital. “This can lead to outbreaks, especially at schools where many young children share the same toys.”
“It’s possible that what we are seeing is still some post-pandemic rebound, but it’s unlikely that this year’s pattern is fully explained by just this factor.”
Rotavirus is associated with many dehydration cases in the hospital due to the degree of diarrhea, according to Hoy.
In some severe cases, the virus can lead to seizures due to electrolyte imbalances from dehydration and loss of electrolytes in the stool.
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“Younger children do not have the reserves that older children and adults have, so they can become more dehydrated quicker and develop more severe electrolyte imbalances, leading to more severe infections,” Hoy said.
“Patients with problems with their immune systems or on medications that can decrease their immune systems can have more severe and prolonged infections, too.”
Treatment and care
Because rotavirus is a viral infection, antibiotics are not effective against it. There is no specific antiviral treatment for the condition, with doctors typically recommending supportive care.
“The mainstay of treatment is hospitalization for rehydration via intravenous (IV) fluids,” Hoy told Fox News Digital. “Sometimes it can take up to two to three days of IV fluids to help get patients rehydrated.”
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Blood draws are often necessary to evaluate patients’ electrolyte levels, such as sodium, potassium, calcium and magnesium, according to the doctor.
“If these electrolyte levels are significantly low, sometimes patients need special IV solutions or individual electrolyte medications,” he added.
“The mainstay of treatment is hospitalization for rehydration via intravenous (IV) fluids,” a doctor told Fox News Digital. (iStock)
Dr. Daniel Park, medical director of the Pediatric Emergency Department at UNC Health in Chapel Hill, North Carolina, noted that most children recover with supportive care, but parents should seek medical attention if a child shows signs of dehydration. Those include decreased urination, lethargy or inability to keep fluids down.
“While rare, rotavirus can be life-threatening in vulnerable populations, especially very young infants or children with underlying medical conditions,” Park told Fox News Digital.
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Prevention strategies
Given the lack of antiviral medications for rotavirus, doctors emphasize the importance of prevention, primarily the vaccine.
There are two rotavirus vaccines – Rotateq (a three-dose series) and Rotarix (a two-dose series). They are given starting at age 2 months as oral drops, not injections, according to Hoy.
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“It’s important to get the rotavirus vaccines on schedule, because these younger infants are at greatest risk if they get rotavirus,” he advised.
Other recommended prevention methods include handwashing with soap and water.
Every day we’re faced with a zillion small choices: Go to sleep early, or watch one more episode of that Netflix drama. Call an old friend to catch up, or cruise social media. Of course, no single action will guarantee a long, healthy life or doom you to an early grave. But those little daily decisions do add up, and over the long term they can make a difference when it comes to both your longevity and your health span, the amount of life spent in relatively good health.
Scroll through this theoretical “day in the life” and select the option that best fits your typical day. Not every situation will apply perfectly, but think about which choice you’d be most likely to make. This isn’t a formal scientific assessment. The goal here isn’t to assign you a “good” or “bad” score, but to help you understand the central factors that shape the way we age and how long we live.
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