‘Tremendous leap forward’: FDA approves first colorectal cancer blood test
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The FDA has approved Guardant Health’s Shield blood test to screen for colorectal cancer in patients aged 45 years and older at average risk for disease, according to a company press release.
With this approval, Shield is the first blood test to be approved as a primary screening option for colorectal cancer in line with other noninvasive screening options, and the first blood test to meet the performance requirements to be covered under Medicare, the company noted.
“The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people,” Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School, said in the release. “The FDA’s approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved.”
The decision comes after the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee met in May and strongly voted in favor of Shield’s approval. The FDA based its approval on data from the ECLIPSE trial, a prospective registrational that compared the Shield test against screening colonoscopy in average-risk adults aged 45 to 84 years from more than 200 clinical trial sites across the U.S.
According to results of the ECLIPSE trial, published in The New England Journal of Medicine, the Shield blood test demonstrated 83% sensitivity for colorectal cancer, 90% specificity for advanced neoplasia and 13% sensitivity for advanced precancerous lesions.
According to the release, Shield’s performance in the trial “is within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.”
“In addition to performance, a screening test’s value should be measured by how accessible it is, and how likely people are to use it,” Michael Sapienza, CEO of the Colorectal Cancer Alliance, said in the release. “Guardant Health’s Shield test checks all three of these boxes and is truly a welcomed addition to the screening options currently available. Giving people choice and offering a blood test that can reach those in harder-to-screen communities, will undoubtedly be a huge step forward in our battle against colorectal cancer.”
According to the release, the Shield blood test can easily be completed at a primary care physician’s office during a routine office visit and offers patients “a convenient and more pleasant alternative screening method” that avoids the time commitments and discomfort typically associated with invasive colonoscopy or stool tests.
“The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data,” AmirAli Talasaz, co-CEO of Guardant Health, said. “Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable. We are... very excited to empower physicians with a viable blood-based screening option to tailor the screening regimen to the unique needs of their patients.”
The company noted the Shield blood test will be available for all eligible patients and Medicare beneficiaries, with expansions into commercial insurance coverage following inclusion of the test in future guidelines from the American Cancer Society and the U.S. Preventive Services Task Force.
Perspective
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Folasade P. May, MD, PhD, MPhil
We are always excited when there is new science and technologies that will help more people get screened for colorectal cancer. With these blood-based screening tests, there is the potential to recruit individuals who have never previously participated in any screening tests to the pool of individuals who are screened. This is very great news since, potentially, we would be bringing in people that we haven't been able to reach before.
However, as we emerge into this new space, I think it is important to recognize that there are often unintended consequences of new technologies. Some things that we need to keep in mind are ensuring that everyone has access to these tests, that these tests are not too costly and that we penetrate into low-income and minority populations.
We also need to make sure that people who are already participating in tests that are better at finding polyps and cancer – like stool-based tests and colonoscopy – do not switch to these blood-based tests. As long as we don't have too much of that happening, this could be great for our field.
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