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First at-home syphilis antibody test gets FDA authorization as STD cases spike in US

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First at-home syphilis antibody test gets FDA authorization as STD cases spike in US

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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.

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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.

AS SYPHILIS CASES SURGE IN THE US, HERE’S WHAT INFECTIOUS DISEASE EXPERTS WANT YOU TO KNOW

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)

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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.”

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“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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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.”

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“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. 

HAWAII HEALTH OFFICIALS CALL FOR ACTION AS SYPHILIS CASES RISE

“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.”

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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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HOUSTON HEALTH OFFICIALS REPORT SYPHILIS OUTBREAK, 128% SPIKE IN CASES AMONG WOMEN

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. 

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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.

Health

Woman’s painful reaction to wine leads to life-changing cancer discovery

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Woman’s painful reaction to wine leads to life-changing cancer discovery

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One woman’s uncomfortable reaction to alcohol led to a grave discovery.

Hollie Thursby, 28, a mother of two from the U.K., told Kennedy News and Media that after giving birth to her second son, Jack, she began experiencing unusual symptoms.

At a checkup for her son, who was a couple of months old, Thursby mentioned that she was experiencing “unbearably itchy skin,” which is known to be a post-partum symptom. The doctor suggested it was due to changing hormones.

DEADLY CANCER RISK SPIKES WITH CERTAIN LEVEL OF ALCOHOL CONSUMPTION, STUDY FINDS

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Thursby added that she occasionally drank a couple glasses of wine. Although she kept the drinking to a minimum, she described having “a lot of pain” down the side of her neck.

“Really quite painful and uncomfortable,” she said, according to the report.

A U.K. mom reported experiencing pain in her neck after drinking a glass or two of wine, which turned out to be one of the first signs that she had cancer. (Kennedy News and Media)

The mother also reported feeling extremely exhausted, which she assumed was due to caring for her children throughout the day.

“I also felt like when I got to bed that someone was sitting on my chest,” she shared.

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In July 2025, Thursby discovered a lump on the side of her neck that she described as “really quite big,” but wasn’t painful, Kennedy News and Media reported.

“It was hard, it didn’t move, but it was there,” she said. “When I turned my neck to the side, you could see it.”

Thursby reportedly began chemotherapy for Stage 2 Hodgkins lymphoma. (Kennedy News and Media)

Thursby’s symptoms turned out to be a form of blood cancer — Stage 2 Hodgkins lymphoma, which means it is in two or more lymph nodes, according to Cancer Research U.K.

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Common symptoms include swelling of the lymph nodes, heavy sweating, weight loss, itching, persistent cough or shortness of breath, high temperatures, and pain in the stomach or lymph nodes after drinking alcohol.

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“Pain when you drink alcohol is actually a known side effect of Hodgkin lymphoma,” she said, per the report. “It’s something about the acidity in the wine and not when you drink other alcohol.”

While alcohol-related pain in Hodgkins lymphoma patients has been “an accepted scientific consensus” since the 1950s, cases are rare, Healthline confirmed.

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Hollie Thursby, 28, and her two sons are pictured above. The mother reported feeling extremely exhausted, which she assumed was due to caring for her children throughout the day. (Kennedy News and Media)

Thursby reportedly began chemotherapy in November, noting that the hardest part is not being able to care for her kids after losing her own mother to a blood disorder called myelodysplasia.

“I grew up without a mum, and it was horrendous. I can’t do that to the boys,” she told Kennedy News and Media. “We’re all devastated, but we all know now, and we’ve got a treatment plan, which is what we need.”

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“I’m just doing everything I can to get better for them. I keep telling myself this is only temporary, I just need to keep going.”

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Anyone experiencing pain or other concerning symptoms after consuming alcohol should consult a doctor for guidance.

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Red light therapy could boost brain health in certain groups, new research suggests

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Red light therapy could boost brain health in certain groups, new research suggests

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Red light therapy has been shown to reduce brain inflammation, protecting people who experience head trauma from long-term health consequences, a University of Utah study has shown.

Brain damage from repeated impact over the years is known to cause cognitive symptoms, ranging from memory issues to full-blown dementia, particularly affecting soldiers and athletes.

Chronic traumatic encephalopathy (CTE) is a progressive, degenerative brain disease linked to repeated head impacts rather than a single injury, according to Mayo Clinic.

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More than 100 former NFL football players have been posthumously diagnosed with CTE, according to the new study, which was published in the Journal of Neurotrauma.

Other research has shown that military personnel in active combat suffer from similar issues, as do first responders and veterans.

The treatment was administered three times a week for 20 minutes using specialized headsets and intranasal devices designed to penetrate the skull. (iStock)

In the new study, the researchers recruited 26 current football players to understand more about the impact of red-light therapy on brain injuries.

The participants received either red light therapy delivered by a light-emitting headset and a device that clips into the nose, or a placebo treatment with an identical device that doesn’t produce light. Players self-administered the therapy three times a week, 20 minutes each time, for 16 weeks.

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“My first reaction was, ‘There’s no way this can be real,’” said first author Hannah Lindsey, Ph.D., in the university press release. “That’s how striking it was.”

Specific wavelengths of light are believed to enter the brain and reduce molecules that trigger inflammation, potentially halting the path toward dementia and other cognitive conditions. (iStock)

Players using the placebo treatment experienced increased brain inflammation over the course of the season. Magnetic resonance imaging (MRI) scans taken at the end of the season showed significantly more signs of inflammation than at the beginning of the season, the study found.

For players who used red-light therapy during the season, their brain inflammation didn’t increase at all.

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ALZHEIMER’S RISK COULD RISE WITH COMMON CONDITION AFFECTING MILLIONS, STUDY FINDS

Previous studies have shown that red light, if powerful enough, can penetrate the skull and reach the brain, where it may reduce inflammation-related molecules.

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“When we first started this project, I was extremely skeptical,” said Elisabeth Wilde, Ph.D., the senior author on the study. “But we’ve seen consistent results across multiple of our studies, so it’s starting to be quite compelling.”

Study limitations

The study was conducted using a small sample size, which led to different levels of inflammation in the treatment and control groups, the researchers acknowledged.

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While the placebo group showed increased brain inflammation during the football season, those receiving red light therapy showed no increase in inflammatory markers. (iStock)

Future large randomized clinical trials will be “crucial to back up the results” in larger populations, they noted.

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“We’ve been trying to figure out how to make sports safer, so that our kids, friends and family can participate in sports safely for the long term while they’re involved in activities that give them happiness and joy,” Carrie Esopenko, Ph.D., second author of the study, said in the release.

“And this really feels like part of the hope for protecting the brain that we’ve been searching for.”

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The team plans to recruit 300 people with persistent symptoms from TBI or concussion for a randomized controlled trial in 2026, with a focus on first responders, veterans and active-duty service members.

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Deadly cancer risk spikes with certain level of alcohol consumption, study finds

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Deadly cancer risk spikes with certain level of alcohol consumption, study finds

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Drinking heavily and consistently over an adult’s lifetime could lead to a higher risk of colorectal cancer, according to a study published in the journal Cancer by the American Cancer Society (ACS).

The study analyzed 20 years of data from more than 88,000 U.S. adults to determine how long-term drinking impacted the risk of developing colorectal cancer (CRC) or precancerous colorectal adenomas (polyps).

The participants reported their average weekly intake of beer, wine and liquor intake during four age periods 18 to 24, 25 to 39, 40 to 54,  and 55 and older.

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“Heavy drinkers” were identified as having more than 14 drinks per week and “moderate drinkers” had between seven and 14 drinks per week.

The observational research revealed that consistent heavy drinking over adulthood was linked to a higher risk of colorectal cancer, especially rectal cancer.

Researchers found a major association between colorectal cancer diagnosis and heavy lifetime drinking. (iStock)

Heavy lifetime drinking was associated with a 25% higher overall CRC risk and nearly double the risk of rectal cancer. Moderate lifetime drinking had a lower overall CRC risk.

Compared to light drinkers, the consistently heavy drinkers had about a 91% higher risk of CRC.

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For colorectal adenomas (precancerous polyps), higher current lifetime drinking did not show a strong pattern, although former drinkers showed a significantly lower risk of non-advanced adenoma compared to current light drinkers.

Out of the 88,092 participants, 1,679 were diagnosed with colorectal cancer.

Out of the 88,092 participants in the study, 1,679 were diagnosed with colorectal cancer. (iStock)

The authors noted that the research was limited, as it was observational and not based on a clinical trial. It also hinged on self-reported alcohol use.

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The findings suggest that consistently heavy alcohol intake and higher average lifetime consumption “may increase CRC risk, whereas cessation may lower adenoma risk,” the researchers stated. Associations “may differ by tumor site,” they added.

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The link between drinking alcohol and cancer is not a new discovery, according to health experts.

In a recent episode of the podcast “The Dr. Mark Hyman Show,” Dr. Mark Hyman, chief medical officer of Function Health in California, detailed how even moderate drinking can impact “nearly every organ system in the body,” due to metabolic stress, inflammation, impaired detoxification and its effect on hormones.

The link between drinking alcohol and cancer is not a new discovery, according to health experts. (iStock)

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Drinking has been found to increase the risk of many cancers, metabolic dysfunction, gut microbiome disturbances and mitochondrial toxins, Hyman said.

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“Bottom line, alcohol taxes every major system in your body, especially your liver, your brain, your gut, your hormones,” he warned.

Reducing or eliminating alcohol can lower the risk of several cancers, according to medical experts. (Getty Images)

In a previous interview with Fox News Digital, Dr. Pinchieh Chiang, a clinician at Circle Medical in San Francisco, shared that taking a break from drinking alcohol for longer periods of time can “reshape health more profoundly.”

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“Over months to a year, we see sustained improvements in blood pressure, liver function and inflammation,” she said. “Those changes directly affect long-term heart disease and stroke risk.”

Chiang added, “Reducing or eliminating alcohol lowers the risk of several cancers, including breast and colorectal, over time.”

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Fox News Digital reached out to the study researchers for comment.

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