Health
First blood test for Alzheimer’s diagnosis cleared by FDA
The first-ever blood test to detect Alzheimer’s disease has been cleared by the U.S. Food and Drug Administration (FDA).
In a Friday press release, the agency announced its approval of the first in-vitro diagnostic device, Lumipulse.
The method is intended for early Alzheimer’s detection in adult patients over the age of 55 who are exhibiting signs and symptoms of the disease.
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The new technology works by detecting amyloid plaques in the brain, a telltale sign of Alzheimer’s.
The first-ever blood test to detect Alzheimer’s disease has been cleared by the U.S. Food and Drug Administration. (iStock)
While PET scans can pick up these plaques, they can be “costly and time-consuming” while exposing patients to radiation, according to the FDA.
The new Lumipulse device reduces the need for a PET scan or other invasive testing, the agency said.
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In a clinical study of 499 plasma samples from cognitively impaired adults, the Lumipulse test detected the presence of amyloid plaques in 91.7% of individuals.
The results indicate that the new blood test can “reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired,” the FDA concluded.
The new technology works by detecting amyloid plaques in the brain, a telltale sign of Alzheimer’s, according to the FDA. (iStock)
The FDA noted the risk of false positive test results from Lumipulse, which could lead to inappropriate diagnosis and unnecessary treatment.
FDA Commissioner Marty Makary, M.D., MPH, wrote in a statement, “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined.”
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“Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients,” he said.
“Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease,” an expert commented. (iStock)
Center for Devices and Radiological Health Director Michelle Tarver, M.D., PhD, also commented in the press release that nearly seven million Americans are living with Alzheimer’s.
“And this number is projected to rise to nearly 13 million,” she said.
“Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”
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An accidental lab discovery has opened the door to entirely new ways of preventing the flu.
While investigating how influenza replicates, researchers discovered that different flu strains use completely different strategies to infiltrate human cells, SWNS reported.
By targeting the specific molecules the viruses rely on, scientists found that they could block them from entering new cells and halt their replication altogether.
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Researchers say these “fundamental insights” into seasonal influenza highlight a clear path toward developing better preventive medications.
“The hope is that fundamental, curiosity-based research like this helps to pave the way for novel strategies to treat and prevent influenza infections,” principal investigator Dr. Emily Bruce, from the University of Vermont’s Larner College of Medicine, said in the SWNS report.
While investigating how influenza replicates, researchers discovered that different flu strains use completely different strategies to infiltrate human cells. (iStock)
While several flu strains cause illness, H1N1 and H3N2 influenza A viruses are the most common. However, current flu tests cannot differentiate between them, and clinical treatments are identical for both.
Although vaccines and antivirals are available, Bruce noted a “dire” need for better medications to stop the virus from spreading cell to xxcell.
“You don’t get sick when a virus is in one cell,” he noted. “You get sick because a virus replicates itself and goes into many more cells.”
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The study, which was published in The Journal of Virology, originally aimed to map how viral RNA segments are transported within cells to create new viral particles.
The team used H1N1 and H3N2 viruses isolated from the nasal passages of positive patients in 2022.
Clinical treatments remain identical for both primary strains of the flu virus. (iStock)
During the investigation, the team unexpectedly stumbled upon a cellular pathway that blocked the virus from entering lung cells, SWNS reported.
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The data revealed that when a specific human protein called Rab11B was depleted, H3N2 viruses failed to enter human lung cells. H1N1 viruses were completely unaffected.
Using reverse genetics, the team mapped this defect and uncovered a brand-new, H3N2-specific role for Rab11B during viral entry.
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This discovery challenged the scientific assumption that all flu viruses enter cells the same way.
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“Viruses are like pirates from different countries hijacking someone’s ship,” Bruce said. “Different viruses, like different types of pirates, use different methods to get onboard.”
This discovery challenged the scientific assumption that all flu viruses enter cells the same way. (iStock)
“We had previously thought that all flu viruses used the same way to get into a cell, but we discovered that this is not true,” she went on. “H1N1 and H3N2 need different proteins to get in, and if you get rid of the right protein, a specific virus can’t get in.”
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While these findings identify a critical cellular pathway for viral entry, the study was conducted using isolated cells, the researchers acknowledged.
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Further research is needed to determine whether blocking the protein is safe and effective within a live, complex human respiratory system.
Bruce and the team hope to conduct further research to determine whether this Rab11B-dependency is a fundamental property of H3N2, or if it’s a trait unique to currently circulating flu strains.
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Eating processed meat like ham, sausage and bacon may be linked to a higher risk of certain types of cancer, according to new research.
While health organizations have already confirmed that processed meat can contribute to colon cancer, this study looked closer at cancers in the upper digestive tract, where the link has historically been less clear.
To understand these connections, researchers from the European Prospective Investigation into Cancer and Nutrition (EPIC), one of the world’s largest long-term nutrition and cancer cohorts, tracked the health and diets of 450,112 people across Europe for an average of 14 years.
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The study group included 131,426 men and 318,686 women, according to the study’s press release.
During the follow-up period, 876 people developed stomach cancer and 215 people developed esophageal adenocarcinoma, which is cancer of the tube connecting the mouth to the stomach.
For female participants, eating both processed meat and white meat was linked to an increased risk of developing the disease. (iStock)
Researchers tracked where the stomach cancers grew, separating them into the upper part of the stomach near the throat and the lower part of the stomach.
The researchers also sorted the tumors into two categories based on how the cancer cells appeared under a microscope: intestinal, which forms more organized structures, and diffuse, in which the cells are more scattered throughout the tissue.
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After adjusting for other lifestyle factors, the researchers found that for every extra 30 grams of processed meat a person ate per day, their overall risk of stomach cancer went up by 9%. Eating that same extra 30 grams a day was also linked to a 13% higher risk of esophageal adenocarcinoma.
A standard single slice of regular deli-sliced ham or lunch meat averages around 28 grams, according to USDA data and nutritional tracking databases.
An extra 20 grams of white meat, such as chicken and turkey, was linked to a 12% higher risk of cancer in the main body of the stomach. (iStock)
An extra 20 grams of white meat, such as chicken or turkey, was linked to a 12% higher risk of cancer in the main body of the stomach, the researchers noted.
The study also revealed differences between men and women. For male participants, only processed meat showed a clear, statistically significant link to a higher risk of stomach cancer. For female participants, however, eating both processed meat and white meat was linked to an increased risk.
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These findings align with global health benchmarks, particularly those established by the World Health Organization’s International Agency for Research on Cancer.
The agency has long classified processed meat as a known human carcinogen, primarily due to its strong, well-documented links to colorectal cancer.
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However, health organizations have also consistently pointed to a potential, yet less definitive, relationship between these meats and cancers of the stomach.
Eating 30 grams of processed meat a day, or the equivalent to one slice of ham, was linked to a 13% higher risk of esophageal adenocarcinoma. (iStock)
Further scientific investigation is needed to confirm the findings and to account for other underlying risk factors, such as certain stomach infections, which could interact with dietary habits.
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A key limitation of the study is its reliance on self-reported diets, which can sometimes lead to inaccuracies in how participants recall their meat consumption over time, the researchers noted.
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The findings were published in the International Journal of Cancer.
Fox News Digital reached out to the researchers requesting comment.
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