A Food and Drug Administration (FDA) advisory group recommended the approval of a novel blood test for colon cancer on Thursday. The panel ruled 7-2 to approve Guardant Health's Shield test, citing its advantages above its risks.
In a news release, Guardant Health CEO Amir Ali Talasaz noted that the panel's support for the authorization of Shield "reinforces the crucial role that a blood test option can have in improving colon cancer screening rates for those at average risk."
Talasaz highlighted the challenges average-risk Americans encounter during screening. He emphasized that Shield detects cancer early when it is most curable and that using this blood test with other noninvasive stool tests might raise screening rates and minimize preventable deaths, as reported by HealthDay.
Today the FDA’s Medical Devices Advisory Committee panel strongly recommended FDA approval of our Shield blood test for #ColorectalCancer screening in adults age 45 and older who are at average risk for the disease.
— Guardant Health (@GuardantHealth) May 23, 2024
Full release: https://t.co/P2gkxLD90S pic.twitter.com/tnpitnaPJZ
Shield Offers A More Convenient Means of Colon Cancer Screening
Shield would be the second blood-based colon cancer test in the United States after Epigenomics' Epi ProColon, which was approved in 2016.
Colonoscopy remains the gold standard for colon cancer diagnostics but its invasiveness and preparation lead to low adherence. Fecal tests like Exact Sciences' Cologuard are also available, although blood testing is more convenient.
However, Guardant's Shield test detected just 13% of advanced adenomas, raising worries about its accuracy. In briefings, FDA personnel raised this concern based on documents. Guardant applied for approval based on one research that found 83% of colon malignancies.
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Accounting for over 50,000 deaths annually, colon cancer is the second-leading cause of cancer mortality in the United States, per the American Cancer Society. The disease is linked to obesity, high alcohol consumption, smoking, processed foods, and sugary beverages.
Colon Cancer Rates Increasing Among Young Individuals
Recent research shows that the disease's prevalence among individuals too young for screening has been rising for decades. The study, which used CDC data to examine illness rates in individuals aged 10 to 44, observed that colorectal cancer is growing across all ages.
According to Dr. Islam Mohamed, a University of Missouri-Kansas City internal medicine resident physician, who led the research, data shows that there is a "trend" though the exact cause of the rising colon cancer is unknown.
Despite the increase, the number of cases among adults under 40 remains modest. Cases involving young people under 30 are rare.
According to NBC News, from 1999 to 2020, colorectal cancer diagnoses in youngsters aged 10-14 increased 500%; The prevalence of 15- to 19-year-old cases increased by about 300%; a 185% increase was seen among 20 to 24-year-olds.
It is important to note that young individuals below 45 with no robust colon cancer history in their family are not eligible to undergo colonoscopy.
Dr. Christopher Lieu, of the University of Colorado School of Medicine, said the "face of colon cancer" is changing. In light of the current trend, researchers are investigating other probable causes of the disease, including the use of certain medications and gut bacteria changes, per The New York Times.
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