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
The Best Time To Take ‘Nature’s Ozempic’ Berberine for Weight Loss and Blood Sugar Control, According to an MD
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Humans have been chewing gum for thousands of years, long after the flavor fades and without any clear nutritional benefit.
The habit dates back at least 8,000 years to Scandinavia, where people chewed birchbark pitch to soften it into a glue for tools. Other ancient cultures, including the Greeks, Native Americans and the Maya, also chewed tree resins for pleasure or soothing effects, National Geographic recently reported.
In the late 19th and early 20th centuries, William Wrigley Jr. transformed chewing gum from a novelty into a mass consumer habit through relentless and innovative marketing. His brands, including Juicy Fruit and Spearmint, promoted gum as a way to calm nerves, curb hunger and stay focused.
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“Are you worried? Chew gum,” an article from 1916 said, according to Kerry Segrave’s book, “Chewing Gum in America, 1850-1920: The Rise of an Industry.” “Do you lie awake at night? Chew gum,” it continued. “Are you depressed? Is the world against you? Chew gum.”
Advertisements have long framed chewing gum as a tool for stress relief and mental sharpness. (Keystone View Company/FPG/Archive Photos/Getty Images)
In the 1940s, a study found chewing resulted in lower tension but couldn’t say why.
“The gum-chewer relaxes and gets more work done,” The New York Times wrote at the time about the study’s results.
Gum became an early form of wellness, and companies are trying to revive that idea today as gum sales decline, according to National Geographic.
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But only now are scientists finally beginning to understand the biology behind those long-standing beliefs.
Chewing gum may briefly affect attention and stress-related brain activity, according to studies. (iStock)
A 2025 review by researchers at the University of Szczecin in Poland analyzed more than three decades of brain-imaging studies to examine what happens inside the brain when people chew gum. Using MRI, EEG and near-infrared spectroscopy research, the authors found that chewing alters brain activity in regions tied to movement, attention and stress regulation.
The findings help clarify why the seemingly pointless task can feel calming or focusing, even once the flavor has faded.
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Chewing gum activated not only the brain’s motor and sensory networks involved in chewing, but also higher-order regions linked to attention, alertness and emotional control, the review found. EEG studies found brief shifts in brain-wave patterns linked to heightened alertness and what researchers call “relaxed concentration.”
Humans have chewed gum for pleasure for thousands of years, according to reports. (iStock)
“If you’re doing a fairly boring task for a long time, chewing seems to be able to help with concentration,” Crystal Haskell-Ramsay, a professor of biological psychology at Northumbria University, told National Geographic.
The review also supports earlier findings that gum chewing can ease stress, but only in certain situations. In laboratory experiments, people who chewed gum during mildly stressful tasks such as public speaking or mental math often reported lower anxiety levels than those who didn’t.
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Chewing gum did not, however, consistently reduce anxiety in high-stress medical situations, such as immediately before surgery, and it offered no clear benefit when participants faced unsolvable problems designed to induce frustration.
Some studies suggest chewing gum can reduce stress in mild situations but not extreme ones. (iStock)
Across multiple studies, people who chewed gum did not remember lists of words or stories better than those who didn’t, the researchers also found, and any boost in attention faded soon after chewing stopped.
Gum may simply feed the desire to fidget, experts suspect.
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“Although these effects are often short-lived, the range of outcomes … underscores chewing gum’s capacity to modulate brain function beyond simple oral motor control,” the researchers wrote.
“However, at this time, the neural changes associated with gum chewing cannot be directly linked to the positive behavioral and functional outcomes observed in studies,” they added.
A 2025 review analyzed decades of MRI, EEG and near-infrared spectroscopy studies on gum chewing. (iStock)
Future research should address longer-term impacts, isolate flavor or stress variables and explore potential therapeutic applications, the scientists said.
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The findings also come with caveats beyond brain science. Although sugar-free gum may help reduce cavities, Fox News Digital has previously reported that dentists warn acids, sweeteners and excessive chewing may harm teeth or trigger other side effects.
Fox News Digital has reached out to the study’s authors for comment.
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