Health
FDA approves new blood test for colon cancer screening: ‘Early detection is critical’
Screening for the second leading cause of cancer deaths just got a bit easier.
The U.S. Food and Drug Administration (FDA) announced the approval of a new blood test for colorectal cancer (CRC).
Shield, made by Guardant Health in California, is the first approved blood test that is considered a primary screening option for the disease and meets Medicare coverage requirements, the company stated.
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The FDA’s approval, announced Tuesday, follows a large clinical trial that included 20,000 average-risk adults, which found that Shield had an 83% sensitivity for the detection of CRC.
Those findings were published in The New England Journal of Medicine in March.
Shield, made by Guardant Health in California, is the first approved blood test that is considered a primary screening option for the disease and meets Medicare coverage requirements, the company stated. (Guardant Health)
There is another approved blood test, Epigenomics’ Epi proColon, but it is a second-line screening option, which means it can only be given to patients who have been offered first-line options and have a history of not completing CRC screening, according to Michael Weist, a spokesperson from Guardant Health.
Robert Smith, PhD, senior vice president of Early Cancer Detection Science for the American Cancer Society in Atlanta, confirmed that Shield is the only blood test currently available for colorectal cancer screening.
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“It compares favorably with other colorectal cancer screening tests,” such as colonoscopy, CT colonography and stool tests, Smith, who is not affiliated with Guardant, told Fox News Digital.
“The test … likely will be more appealing to people who have never been screened, or not recently screened,” he added.
The FDA’s approval follows a large clinical trial that included 20,000 average-risk adults, which found that Shield had an 83% sensitivity for the detection of colorectal cancer. (Guardant Health)
The key advantage of the blood test is that it can be done during a routine doctor’s appointment without the need for prepping or taking an entire day off from work.
“It offers the potential to detect colorectal cancer in a person who is non-adherent with screening recommendations, asymptomatic and willing to get this test based on preference, convenience or both,” Smith said.
“Compared to colonoscopy, it is simpler and less time-consuming.”
Shield has shown “reasonable sensitivity and specificity compared to other blood/stool tests,” according to Dr. Shuji Ogino, chief of the Molecular Pathological Epidemiology program at Brigham and Women’s Hospital, which is a member of Mass General Brigham in Boston.
“Compared to colonoscopy, it is simpler and less time-consuming,” Ogino, who is not associated with Guardant, told Fox News Digital.
Risks and limitations
While the risks of the Shield test have not been studied in a population of regular users, they are likely to be minimal, according to ACS’ Smith.
“However, the Shield test does not offer the same level of benefit to prevent colorectal cancer by detecting and removing precursor lesions (polyps), which is a significant benefit from regular screening with the currently recommended tests,” Smith cautioned.
The Shield blood test is made by Guardant Health, which is based in Redwood City, California. (Guardant Health)
That downside would be offset by more unscreened people choosing to get screenings, he noted.
“The Shield blood test does have a lower degree of sensitivity than the Cologard stool test for detecting colon cancer,” Stephen Grabelsky, M.D., a hematologist and medical oncologist at the Eugene M. & Christine E. Lynn Cancer Institute at Boca Raton Regional Hospital, told Fox News Digital.
The test is only intended for people with a standard risk for colon cancer, which excludes patients with a family history of colon cancer or a personal history of inflammatory bowel disease, Grabelsy added. (He also was not involved in the test’s development.)
Early detection is key
The compliance rate for colorectal cancer screenings is only about 59% — well below the National Colorectal Cancer Roundtable’s goal of 80% for eligible individuals, according to Weist.
The test is expected to be commercially available by this fall.
“More than one out of three eligible Americans – over 50 million people – do not complete CRC screenings, often due to the perception that other available options, such as colonoscopies or stool-based tests, are invasive, unpleasant or inconvenient,” he said.
When detected early, colon cancer has a relative survival rate of 91% — compared to just 14% if the cancer has spread to distant parts of the body.
“Early detection is critical,” Weist said. “The most effective screening test is the test that gets done.”
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The Shield test is indicated for colorectal cancer screening in individuals age 45 and older who have an average risk for the disease, he told Fox News Digital.
The test is expected to be commercially available by this fall.
The Shield test is indicated for colorectal cancer screening in individuals 45 and older who are at average risk for the disease. (Guardant Health)
Patients interested in the Shield test should discuss the benefits and limitations with a health care provider before making a choice, Smith recommended, and should also determine whether their insurance will cover it.
“It is important to appreciate that a colorectal cancer screening test that is positive is not complete until the patient has had a colonoscopy,” Smith noted.
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“Any non-colonoscopy screening test for colorectal cancer that is positive must be followed up with a colonoscopy.”
Health
New ways to prevent flu revealed in ‘accidental’ lab breakthrough, study finds
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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.
Health
One extra serving of processed meat a day linked to higher cancer risk
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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.
Health
The Surprising Hormone That Could Make Menopause Weight Loss Easier
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