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
Could ‘humanmaxxing’ actually help you live longer? Here’s what experts say
Medical expert analyzes trending IV therapy, concerns about peptides
Dr. Mike Varshavski joins ‘Fox & Friends’ for Wellness Week, examining trending self-care treatments. He evaluates IV vitamin therapy, highlighting its hospital-critical role versus unproven benefits for general wellness, citing potential risks like vitamin imbalance. Dr. Mike also differentiates creatine, a research-backed supplement, from unregulated peptides marketed with unverified anti-aging and muscle growth promises, urging caution for patients.
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We are officially living in the “maxxing” era.
From “looksmaxxing” to improve appearance to “sleepmaxxing” for better rest, these viral terms all point to the same goal: squeezing every ounce of potential out of a specific trait or habit.
With a growing focus on optimizing wellness and maximizing longevity, the trend has evolved into what’s known as “humanmaxxing,” sparking a bigger question: How far can people go to optimize the human body?
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While there is no single definition of humanmaxxing, the trend generally refers to efforts to optimize health, performance and longevity through a combination of lifestyle habits, health tracking, supplements and, in some cases, more experimental interventions.
While there is no single definition of humanmaxxing, the trend generally refers to efforts to optimize health, performance and longevity through a combination of lifestyle habits, health tracking, supplements and, in some cases, more experimental interventions. (iStock)
For some, the movement begins with biohacking. According to Dave Asprey, a Texas-based wellness expert who refers to himself as the “father of biohacking,” optimizing your body starts with changing your environment.
Asprey has defined biohacking as “the art and science of changing the environment around you or inside you so that you have full control of your own biology.”
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His public advice focuses on boosting cellular energy through everyday choices like intermittent fasting, high-fat diets, red-light therapy and supplement routines.
“My goal right now is 180 years, because I’m doing something about it now instead of waiting,” he once said.
Clinical experts warn that extreme self-experimentation skips the rigorous safety checks that typical medical science requires. (iStock)
Others have embraced a more data-driven approach. Tech entrepreneur Bryan Johnson, creator of the multimillion-dollar longevity project Blueprint in Los Angeles, argues that optimizing the body means removing human error from health decisions and instead relying on medical data.
“Methodically, we sought to build an algorithm with science and data that could better care for me than I can myself,” Johnson wrote on his website. “My mind did not have the authority to override the algorithm.”
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Johnson’s routine involves tracking hundreds of health metrics, eating a precisely measured diet, taking dozens of supplements, and undergoing advanced medical treatments in an effort to reduce his biological age.
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At the far end of the spectrum are those investing in technologies aimed at pushing the limits of human performance.
London-based tech investor Christian Angermayer recently described humanmaxxing as a strategy toward human maximization.
Tech entrepreneur Bryan Johnson, creator of the multimillion-dollar longevity project Blueprint, argues that optimizing the body means removing human error from health decisions and instead relying on medical data. (iStock)
“I don’t think we should become something different, because I think humans are awesome, but I think we can maximize the potential [that] is already in us,” he said in an interview with The New York Times.
Angermayer’s investment firm, Apeiron Investment Group, focuses on technologies intended to help people “live longer, healthier and more fulfilling lives.” He also founded atai Life Sciences, a biotechnology company that develops psychedelic treatments for mental health conditions that are currently being evaluated in clinical trials.
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As interest in humanmaxxing grows, mainstream health experts urge consumers to separate evidence-based wellness practices from experimental interventions.
Public guidance from the National Institute on Aging notes that while some anti-aging therapies have shown promise in laboratory research, there is not yet sufficient evidence that they can safely extend human life.
As interest in humanmaxxing grows, mainstream health experts urge consumers to separate evidence-based wellness practices from experimental interventions. (iStock)
Clinical experts also caution that extreme self-experimentation can bypass the rigorous safety standards applied to conventional medical treatments.
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According to the Endocrine Society, taking substances such as testosterone or growth hormone without a medical need can lead to serious health risks, including cardiovascular complications and long-term disruption of the body’s chemical balance.
While many humanmaxxing habits overlap with standard healthy lifestyle practices, experts say consumers should be cautious of expensive or experimental interventions that promise dramatic anti-aging or longevity benefits without strong scientific evidence.
Health
New blood test detects 90% of aggressive prostate cancer cases, beating current screenings
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A new test could make it easier to detect high-risk prostate cancer cases earlier.
The blood test, called Stockholm3, is showing promise in clinical trials, beating out the traditional, standard prostate-specific antigen (PSA) test.
In a new study published in the Annals of Internal Medicine, researchers from the Karolinska Institutet in Sweden studied the test’s efficacy in more than 12,000 men — mostly Swedish or European — aged 50 to 74.
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All participants were tested with PSA and Stockholm3 and were followed for two years. During the follow-up period, 443 men were diagnosed with aggressive prostate cancer.
Stockholm3 detected 90% of aggressive prostate cancer cases compared to 74% for PSA tests.
Stockholm3 detected 90% of aggressive prostate cancer cases compared to 74% for PSA tests. (iStock)
Stockholm3 missed “significantly fewer” serious cancer cases than PSA. The number of men incorrectly classified as high-risk was similar across both tests, according to a press release.
Thorgerdur Palsdottir, a researcher at the Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, wrote in a statement that one of the major challenges in prostate cancer is being able to identify the cases that are “truly dangerous.”
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“Our results show that Stockholm3 identifies significantly more aggressive cancer cases than PSA without increasing the number of unnecessary follow-ups,” she said.
“These results point toward a potential change in how prostate cancer screening can be conducted,” the researcher added. “A more precise blood test could enable earlier detection of aggressive disease while reducing the number of unnecessary follow-up examinations and procedures.”
“A more precise blood test could enable earlier detection of aggressive disease while reducing the number of unnecessary follow-up examinations and procedures,” a researcher commented. (iStock)
Study co-author Hari Vigneswaran, chief medical officer of Stockholm3-maker A3P Biomedical, commented on these “promising” findings in an interview with Fox News Digital.
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He confirmed that the PSA has been the standard for prostate cancer screening since the 1990s despite its “well-documented limitations.”
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“It leads to invasive and costly follow-up testing, contributes to over-diagnosis of non-aggressive cancers and, most importantly, it misses a substantial share of aggressive disease,” Vigneswaran said.
When aggressive prostate cancer is found while still confined in the prostate, the five-year survival is close to 100%. (iStock)
When aggressive prostate cancer is found while still confined in the prostate, the five-year survival rate is close to 100%, which highlights the importance of early detection, according to the doctor.
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Data from the National Cancer Institute’s SEER database show that metastatic prostate cancer has risen over the past decade, suggesting that “we have not improved early detection of the aggressive, curable disease that screening is meant to catch,” Vigneswaran said.
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“The goal of screening is to find the cancers that need treatment while they are still curable, without raising the number of men who screen positive but don’t have aggressive disease,” he said.
Stockholm3 could reduce the need for unnecessary MRIs and biopsies, according to the researcher. (Getty Images)
Stockholm3 could reduce the need for unnecessary MRIs and biopsies, according to the researcher.
The findings did have some limitations. Stockholm3 is an investigational device and is not available for sale in the U.S., Vigneswaran noted.
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The test estimates a man’s risk of aggressive prostate cancer, but a biopsy remains the gold standard for confirming the disease.
The company plans to seek FDA approval to use the test for routine screening and will “generate the evidence needed to support that pathway, including U.S. data,” Vigneswaran said.
Health
This Protein Smoothie Trick Helps Women Over 40 Lose Twice as Much Fat
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