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.
Health
New Mexico newborn dies from Listeria infection after mother drank raw milk while pregnant: state officials
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A newborn baby in New Mexico died from a Listeria infection likely tied to the mother drinking raw milk while pregnant, according to state health officials.
The New Mexico Department of Health issued a warning Tuesday urging people to avoid consuming raw dairy products following the newborn’s death. Health officials believe the “most likely” source of infection was the mother drinking unpasteurized milk during pregnancy.
While investigators said they could not determine the exact cause, they said the “tragic death underscores the serious risks raw dairy poses to pregnant women, young children, elderly New Mexicans and anyone with a weakened immune system.”
Raw milk has seen a surge in popularity amid the Make America Healthy Again movement led by Health and Human Services Secretary Robert F. Kennedy Jr.
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Health officials say a New Mexico newborn died from a Listeria infection likely linked to the mother drinking raw milk during pregnancy. (iStock)
The U.S. Food and Drug Administration issued a regulation decades ago prohibiting the interstate sale of raw milk, but the drink is not federally banned, leaving individual states to decide whether it’s safe for human consumption.
“Individuals who are pregnant should only consume pasteurized milk products to help prevent illnesses and deaths in newborns,” Dr. Chad Smelser, deputy state epidemiologist for the New Mexico Department of Health said in a statement.
Raw milk has not been pasteurized — a process that heats milk to remove disease-causing germs.
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A New Mexico newborn’s death has been linked by health officials to a Listeria infection tied to raw milk consumption. (iStock)
Consuming food or beverages made from raw milk can expose people to Campylobacter, Cryptosporidium, E. coli, Listeria, Brucella and Salmonella, according to the Centers for Disease Control and Prevention (CDC).
Listeria is the third leading cause of death from foodborne illness in the U.S., infecting about 1,250 people and causing roughly 172 deaths each year, according to the CDC.
The CDC notes that certain groups of people, including children under the age of 5, adults over 65, pregnant women and people with weakened immune systems, have a higher risk of serious illness.
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New Mexico health officials are warning against consuming raw dairy products after a newborn died from a Listeria infection. (iStock)
“New Mexico’s dairy producers work hard to provide safe, wholesome products and pasteurization is a vital part of that process,” Jeff M. Witte, New Mexico secretary of agriculture, said in a statement. “Consumers, particularly those at higher risk, are encouraged to choose pasteurized dairy products to reduce the risk of serious foodborne illness.”
Last August, an outbreak of E. coli and Campylobacter linked to raw milk from a Florida farm sickened 21 people, including six children.
Health
Marijuana compound may help prevent dementia when paired with common drug
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As marijuana’s potential health benefits are under debate, new research has found that THC could have a powerful and positive effect on the brain.
Researchers at the University of Texas (UT) at San Antonio, Long School of Medicine, recently discovered that THC (tetrahydrocannabinol, the main psychoactive compound in marijuana) could prevent the development of Alzheimer’s disease – but only when paired with an anti-inflammatory drug called celecoxib.
Celecoxib is a selective COX-2 inhibitor that is commonly prescribed for arthritis and pain.
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While THC has previously been shown to have anti-inflammatory and neuroprotective properties, it’s also been linked to negative effects on the brain, particularly in learning and memory, according to a UT Health press release.
Combining THC with an anti-inflammatory drug, however, could provide the same benefits with fewer negative side effects.
THC could be powerful against cognitive decline when combined with an anti-inflammatory, a new study suggests. (iStock)
The study, which was published in the journal Aging and Disease, paired low-dose THC extract with celecoxib, which was administered to mice daily for 30 days.
The mice received the treatments before the development of memory symptoms to measure the impact on preventing or delaying Alzheimer’s.
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The results showed improved cognition, learning and memory, as well as decreased markers of neuroinflammation and reduced Alzheimer’s-related brain pathology, the release stated.
Although THC alone had the same results, it also increased inflammatory signals, while the combination dosage did not.
The THC and celecoxib combo improved cognition, learning and memory, while also decreasing markers of neuroinflammation and reduced Alzheimer’s-related brain pathology. (iStock)
“What really mattered was behavior. If cognition is not improved, then the treatment doesn’t matter. And that’s where the combination clearly worked better than THC alone,” noted lead study author Chu Chen, Ph.D., professor in the Department of Cellular and Integrative Physiology.
Years of research led Chen to connect the dots on how THC can manipulate the brain and why it’s difficult to use safely for neurological conditions, according to UT Health.
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“When THC is given, it unexpectedly increases COX-2 in the brain. That increase is closely associated with learning and memory impairment,” Chen said.
Both THC and celecoxib are FDA-approved for use in humans, which could provide a “real advantage” in moving along to clinical trials, according to UT Health.
“What really mattered was behavior. If cognition is not improved, then the treatment doesn’t matter.”
Future studies will investigate whether the drug combination can slow disease progression or reverse deficits after symptoms have appeared.
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“This work has taken many years. But now we’re at a point where basic neuroscience discoveries are pointing toward something that could realistically move into the clinic,” Chen said.
Dr. Paul Saphier, a neurosurgeon and founder of Coaxial Neurosurgical Specialists in New Jersey, called this research an “exciting breakthrough with a huge potential impact for patients and their families.”
“We know that the buildup of the plaques related to Alzheimer’s [beta-amyloid plaques] are the result of chronic inflammation.” (iStock)
“Neurocognitive deterioration has been linked to conditions that cause inflammation within the brain — prior brain bleeds, strokes, tumors and infections,” he told Fox News Digital. “We also know that the buildup of the plaques related to Alzheimer’s [beta-amyloid plaques] are the result of chronic inflammation.”
“So, it makes sense that this combination therapy [might] help limit the production of this amyloid and thereby reduce the progression of the disease.”
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Saphier said the drugs’ FDA approval status is “encouraging,” as it may “ultimately ease the availability for patients, if the trial proves successful.”
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“I look forward to the results of this trial, as well as any future trials that look at limiting the effects of chronic inflammation within the central nervous system.”
Health
Cancer may trigger unexpected defense against Alzheimer’s disease, researchers say
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Puzzling cancer and Alzheimer’s link explored in new study: ‘SHORT QUOTE’
A new study may help clarify a long-observed link between cancer history and reduced Alzheimer’s risk.
The research, published in the journal Cell, used mouse models to explore how the biological changes associated with cancer may affect the progression of the most common dementia type.
The findings suggest that certain cancers release a protein called cystatin-C that can travel through the bloodstream and enter the brain, an area that many Alzheimer’s treatments have difficulty reaching.
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Cystatin-C binds to harmful amyloid protein clumps linked to Alzheimer’s and activates a protein called TREM2, which acts like an on-switch for the brain’s immune cells.
When activated, those cells begin clearing away existing amyloid plaques, a process that was associated with reduced plaque buildup and improved cognitive function, the study found.
New research suggests that cancer-related biological changes may help explain why a history of cancer is linked to lower Alzheimer’s risk. (iStock)
Dr. Bob Arnot, a Vermont-based internal medicine physician, told Fox News Digital that the findings help clarify a pattern doctors have observed for years.
“Scientists have long observed a puzzling statistical pattern known as ‘inverse comorbidity’ — people with a history of cancer are less likely to develop Alzheimer’s disease, and people with Alzheimer’s are less likely to develop cancer,” said Arnot, who was not involved in the study.
Cystatin-C sticks to harmful amyloid clumps and turns on brain immune cells, helping them clear plaques and improve brain function. (iStock)
The findings suggest that biological signals tied to certain cancers may slow or reverse key features of Alzheimer’s disease.
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Arnot said the research is notable because it identifies a specific biological pathway that could be targeted for future Alzheimer’s treatments.
“This approach targets existing amyloid plaques, not just early prevention. That distinction could be critical for patients who already have established disease,” he said.
The results suggest that cancer-related biological signals may help slow or even reverse some core aspects of Alzheimer’s disease. (iStock)
Arnot cautioned that the findings do not mean cancer itself is protective.
“This study does not suggest that cancer is protective, desirable or a viable therapy,” he said. “Instead, it reveals that biological programs activated during cancer can inadvertently engage protective immune mechanisms in the brain.”
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The research suggests that future treatments could focus not just on slowing Alzheimer’s, but also on clearing harmful buildup in the brain, Arnot added.
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The results were based on experiments in animal models, and further research is needed to determine whether the same effects occur in humans, the researchers noted.
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