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.”
Over the two and a half years following the 2022 rollout of the 988 national suicide prevention hotline, the rate of suicides among young people in the United States dropped 11 percent below projections, decreasing most sharply in states with a higher volume of answered 988 calls, a new study has found.
The findings, published today as a research letter in JAMA, compared suicide deaths from July 2022 to December 2024 with sophisticated mathematical projections that were based on historical trends. This yielded good news, with 4,372 fewer suicides of adolescents and young adults, ages 15 to 34, than had been projected.
To ensure that the decline was related to the use of the hotline, researchers at Harvard Medical School teased out the trends in states with high and low usage of the hotline. The findings were striking: The 10 states with the largest increases in 988 calls experienced an 18.2 percent reduction in observed suicides compared with expected suicides; in the 10 states with the lowest uptake, the reduction was smaller, 10.6 percent.
The results suggest that the government’s investment in the 988 rollout has translated into “a measurable reduction of deaths,” said Dr. Vishal Patel, a resident physician at Brigham and Women’s Hospital and one of the authors of the study.
“What our study has added,” he said, “is evidence for the deeper benefit of the program, and that is, that at the population level, among young people at least, suicide mortality is lower than it would have been without the program.”
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He added, “The implication of that is that sustained funding for this program matters.”
The United States rolled out the three-digit hotline with bipartisan support in July 2022, replacing a 10-digit hotline number, and augmented it with a $1.5 billion investment in crisis center capacity. Since its inception, the service has fielded more than 25 million contacts, according to the Department of Health and Human Services. The agency has asked Congress for $534.6 million to fund the program for 2027.
Last summer, the Trump administration terminated one element of the hotline, the Press 3 option for L.G.B.T.Q.+ callers. The Substance Abuse and Mental Health Services Administration said that the Press 3 option was being discontinued because it had exhausted its funding from Congress and that the hotline would “focus on serving all help seekers.”
But advocacy groups and policymakers protested the decision, and in testimony before the Senate on Tuesday, the health secretary, Robert F. Kennedy Jr., said his agency was planning to restore the Press 3 option.
Dr. Patel said his group had become curious about measuring the program’s effectiveness after Press 3 was eliminated. While call volume and satisfaction surveys suggested that 988 was succeeding, he said, the harder question was, “Did the creation of this 988 program, the transition from the old hotline to this hotline, actually move the needle on suicide mortality?”
Experts said it was difficult to tease out the beneficial effect of 988 from other things that changed in 2022, the year that the new hotline was created. Around that time, suicide prevention programs were being introduced in schools, in faith communities and on social media, but more important, the pandemic was ending.
“We were finally out of this crazy time, and there was a sense of optimism and hope,” said Jonathan B. Singer, a professor of social work at Loyola University Chicago and a co-author of “Suicide in Schools.” He called the downward trend in youth suicides “encouraging, but it is tempered by the fact that we don’t have a good explanation as to why.”
The authors acknowledged that their findings could not account for the influence of social and economic changes, changes in mental health services or public awareness about services.
But they did make comparisons to exclude other possible explanations. The authors looked for similar effects among American adults over 65, who are less likely to use the hotline. In that group, there was a reduction in suicides that exceeded expectations, but it was smaller, at just 4.5 percent.
To ensure the decline in suicides did not reflect a general improvement in young-adult mortality, the researchers tracked cancer deaths, and found there was no change. They also looked at the rates of suicide among young people in England, where no change had been made to the national crisis line in that time period; they found no reduction in youth suicides there.
Hannah Wesolowski, chief advocacy officer for the National Alliance on Mental Illness, said she was persuaded that the hotline had contributed to the improvement in suicide rates, in part because it did not appear among English youths or in older Americans.
“To me, that really helps hone in that this might really be the differentiator,” she said. “We are seeing potentially a pretty significant decline in suicides among young people. For public policy, this is strong evidence to double down on that we are doing.”
Emily Hilliard, a senior press secretary at the Department of Health and Human Services, said H.H.S. and SAMHSA are “committed to ensuring that all Americans have access” the 988 line, which she said “clearly provides lifesaving support, helping millions of people every year.”
If you are having thoughts of suicide, call or text 988 to reach the 988 Suicide and Crisis Lifeline or go to SpeakingOfSuicide.com/resources for a list of additional resources.
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A highly contagious digestive virus is surging across the U.S., experts warn.
Rotavirus, a double-stranded RNA virus, causes acute gastroenteritis — inflammation of the stomach and intestines — which can lead to severe diarrhea, vomiting, fever and stomach pain.
The virus primarily affects infants and young children, but there have also been outbreaks in elderly populations, such as nursing homes.
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Data from the Centers for Disease Control and Prevention shows that in the week ending April 4, out of 2,329 rotavirus tests, 7.3% were positive for the infection. Last year’s highest infection rate was 6.77% as of the week ending April 19.
Rotavirus, a double-stranded RNA virus, causes acute gastroenteritis — inflammation of the stomach and intestines — which can lead to severe diarrhea, vomiting, fever and stomach pain. (iStock)
“We’re seeing a lot of rotavirus in the wastewater right now,” Dr. Marc Siegel, Fox News senior medical analyst, confirmed to Fox News Digital. “Testing for rotavirus is way down, but the percentage of positive tests is up.”
While the virus typically peaks in the spring, it is not currently slowing down, he noted.
Why cases may be rising
Patricia Pinto-Garcia, M.D., a medical editor at GoodRx who is based in California, said there are several possible reasons for the rotavirus spike.
“Vaccine rates are down overall among young children, as they decreased during COVID,” she told Fox News Digital. “This means there’s a growing number of infants and young children who are vulnerable to infection.”
The rotavirus vaccine series must be completed by the time a child is 8 months old, she noted.
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As a result of the declining vaccinations, herd immunity isn’t protecting vulnerable children, according to Pinto-Garcia. “Children who haven’t finished the vaccine series yet, are too young to get vaccinated, or can’t get the vaccine due to medical illness are more likely to get exposed to the illness because other children aren’t vaccinated,” she said.
Siegel noted that before the vaccine became available, rotavirus resulted in 55,000 to 70,000 in the U.S. per year.
“Vaccine rates are down overall among young children, as they decreased during COVID,” a doctor told Fox News Digital. “This means there’s a growing number of infants and young children who are vulnerable to infection.” (iStock)
“I am concerned that the vaccination rate has been declining over the past seven years and is continuing to decline in the current climate of vaccine skepticism,” he said.
Surveillance methods are also much better than they used to be, Pinto-Garcia noted, which means public health experts are able to pick up and track cases better than ever before.
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“But we see that rotavirus-related healthcare visits are also up, so improved detection is not the only reason we are seeing this spike,” she said.
The COVID pandemic also disrupted the pattern of infections, according to Pinto-Garcia, so it’s “tricky” to compare the current levels against older cycles.
“It’s possible that what we are seeing is still some post-pandemic rebound, but it’s unlikely that this year’s pattern is fully explained by just this factor,” she added.
Transmission and risk
Dr. Zachary Hoy, a pediatric infectious disease specialist at Pediatrix Medical Group based in Nashville, Tennessee, often sees young patients with rotavirus.
“Rotavirus is spread via the fecal-oral route, meaning that a person comes into contact with virus droplets from contact with other children or adults, or from contact with objects such as toys that have been contaminated with the virus from someone who is sick,” he told Fox News Digital. “This can lead to outbreaks, especially at schools where many young children share the same toys.”
“It’s possible that what we are seeing is still some post-pandemic rebound, but it’s unlikely that this year’s pattern is fully explained by just this factor.”
Rotavirus is associated with many dehydration cases in the hospital due to the degree of diarrhea, according to Hoy.
In some severe cases, the virus can lead to seizures due to electrolyte imbalances from dehydration and loss of electrolytes in the stool.
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“Younger children do not have the reserves that older children and adults have, so they can become more dehydrated quicker and develop more severe electrolyte imbalances, leading to more severe infections,” Hoy said.
“Patients with problems with their immune systems or on medications that can decrease their immune systems can have more severe and prolonged infections, too.”
Treatment and care
Because rotavirus is a viral infection, antibiotics are not effective against it. There is no specific antiviral treatment for the condition, with doctors typically recommending supportive care.
“The mainstay of treatment is hospitalization for rehydration via intravenous (IV) fluids,” Hoy told Fox News Digital. “Sometimes it can take up to two to three days of IV fluids to help get patients rehydrated.”
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Blood draws are often necessary to evaluate patients’ electrolyte levels, such as sodium, potassium, calcium and magnesium, according to the doctor.
“If these electrolyte levels are significantly low, sometimes patients need special IV solutions or individual electrolyte medications,” he added.
“The mainstay of treatment is hospitalization for rehydration via intravenous (IV) fluids,” a doctor told Fox News Digital. (iStock)
Dr. Daniel Park, medical director of the Pediatric Emergency Department at UNC Health in Chapel Hill, North Carolina, noted that most children recover with supportive care, but parents should seek medical attention if a child shows signs of dehydration. Those include decreased urination, lethargy or inability to keep fluids down.
“While rare, rotavirus can be life-threatening in vulnerable populations, especially very young infants or children with underlying medical conditions,” Park told Fox News Digital.
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Prevention strategies
Given the lack of antiviral medications for rotavirus, doctors emphasize the importance of prevention, primarily the vaccine.
There are two rotavirus vaccines – Rotateq (a three-dose series) and Rotarix (a two-dose series). They are given starting at age 2 months as oral drops, not injections, according to Hoy.
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“It’s important to get the rotavirus vaccines on schedule, because these younger infants are at greatest risk if they get rotavirus,” he advised.
Other recommended prevention methods include handwashing with soap and water.
Every day we’re faced with a zillion small choices: Go to sleep early, or watch one more episode of that Netflix drama. Call an old friend to catch up, or cruise social media. Of course, no single action will guarantee a long, healthy life or doom you to an early grave. But those little daily decisions do add up, and over the long term they can make a difference when it comes to both your longevity and your health span, the amount of life spent in relatively good health.
Scroll through this theoretical “day in the life” and select the option that best fits your typical day. Not every situation will apply perfectly, but think about which choice you’d be most likely to make. This isn’t a formal scientific assessment. The goal here isn’t to assign you a “good” or “bad” score, but to help you understand the central factors that shape the way we age and how long we live.
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