Screening for the second most significant cause of cancer deaths has become more accessible.
The U.S. Food and Drug Administration (FDA) has approved a groundbreaking blood test for colorectal cancer (CRC).
Developed by Guardant Health in California, Shield is the first blood test approved as a primary screening option for the disease and qualifies for Medicare coverage, according to the company.
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The FDA’s announcement on Tuesday was based on a comprehensive clinical trial involving 20,000 average-risk adults, which demonstrated that Shield has an 83% sensitivity in detecting CRC.
The findings of this study were published in The New England Journal of Medicine back in March.
Shield, created by Guardant Health in California, is the first blood test approved as a primary screening method for colorectal cancer and meets Medicare coverage criteria. (Guardant Health)
While there is another approved blood test, Epigenomics’ Epi proColon, it serves as a second-line screening option, only recommended for patients who have already been presented with first-line options and have a history of not completing CRC screenings, stated Michael Weist, a representative from Guardant Health.
Robert Smith, PhD, the senior vice president of Early Cancer Detection Science for the American Cancer Society in Atlanta, verified that Shield is currently the only blood test available for colorectal cancer screening.
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“It compares favorably with other colorectal cancer screening methods,” which include colonoscopy, CT colonography, and stool tests, Smith, independent of Guardant, informed Fox News Digital.
“This test is likely to attract individuals who have never undergone screening, or who have not been screened recently,” he added.
The FDA’s endorsement came after a comprehensive clinical trial of 20,000 average-risk adults, which showed that Shield had an 83% sensitivity rate for colorectal cancer detection. (Guardant Health)
This blood test’s significant advantage lies in the fact that it can be performed during a routine doctor’s appointment, eliminating the need for extensive preparation or taking an entire day off work.
“It has the potential for detecting colorectal cancer in individuals who are non-compliant with screening recommendations, asymptomatic, and who prefer this test due to convenience,” Smith remarked.
“In comparison to colonoscopy, it is easier and less time-intensive.”
According to Dr. Shuji Ogino, chief of the Molecular Pathological Epidemiology program at Brigham and Women’s Hospital, which is part of Mass General Brigham in Boston, Shield has demonstrated “adequate sensitivity and specificity compared to other blood and stool tests.”
“It is simpler and requires less time than a colonoscopy,” Ogino, who is not affiliated with Guardant, shared with Fox News Digital.
Risks and limitations
While the risk factors associated with the Shield test haven’t been evaluated within a standard user demographic, they are expected to be minimal, as stated by ACS’ Smith.
“However, the Shield test does not provide the same level of benefits for preventing colorectal cancer through the identification and removal of precursors (polyps), which is a critical advantage offered by conventional screening methods,” Smith cautioned.
The Shield blood test is produced by Guardant Health, located in Redwood City, California. (Guardant Health)
This limitation could be mitigated by motivating more unscreened individuals to opt for screenings, he noted.
“The Shield blood test does exhibit a lesser degree of sensitivity compared to the Cologard stool test for detecting colon cancer,” stated Stephen Grabelsky, M.D., a hematologist and medical oncologist at the Eugene M. & Christine E. Lynn Cancer Institute at Boca Raton Regional Hospital, in a conversation with Fox News Digital.
The test is exclusively meant for those with an average risk for colon cancer, excluding patients with a family history of the disease or those with a personal history of inflammatory bowel disease, Grabelsy added. (He also was not involved in developing the test.)
Early detection is crucial
The compliance rate for colorectal cancer screenings stands at only 59%—far below the National Colorectal Cancer Roundtable’s target of 80% for eligible individuals, as per Weist.
The test is anticipated to be available commercially by this upcoming fall.
“More than a third of eligible Americans—over 50 million—have not completed CRC screenings, frequently due to the belief that other existing options, such as colonoscopies or stool-based tests, are invasive, uncomfortable, or inconvenient,” he explained.
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When identified at an early stage, colon cancer possesses a relative survival rate of 91%—as opposed to just 14% if the cancer has metastasized to distant parts of the body.
“Early detection is paramount,” Weist emphasized. “The most effective screening test is simply the one that is utilized.”
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The Shield test is designated for colorectal cancer screening in individuals who are 45 years of age and older and have an average risk for the disease, he informed Fox News Digital.
The test is expected to become commercially available by this fall.
The Shield test is intended for colorectal cancer screening in individuals aged 45 and older who are at average risk for the disease. (Guardant Health)
Patients considering the Shield test should consult with a health care provider regarding its pros and cons before deciding, and check if their insurance will cover it, advised Smith.
“It’s crucial to understand that a positive result from a colorectal cancer screening test does not equate to a complete assessment until a colonoscopy has been performed,” Smith pointed out.
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“Any colorectal cancer screening test that returns a positive must be followed up with a colonoscopy.”
