Colorectal (CRC) detection has become a red hot field, as concerns about rising numbers of young adult cases and competition among multi-cancer panels heat up. Guardant Health took two giant steps forward recently with first the approval of its liquid biopsy test, Guardant360 Liquid CDx, and then the listing of its blood-based Shield test by the American Cancer Society (ACS) as a choice for CRC screening of adults age 45 and older who are at average risk of the disease.
In an updated guideline released today, the ACS added blood-based screening tests, and specifically Shield, to its list of recommended choices for the patients in this subset who have not completed or have declined visual exams and stool tests. The group specifically names Shield, which was approved by the U.S. Food and Drug Administration in 2024.
Shield is an in vitro diagnostic test that detects CRC-derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit. The test is performed at Guardant.
These two advances put Guardant in an excellent position in the cancer liquid biopsy market, which is currently valued at between $7B and $12B and expected to double over the next ten years.
A spokesperson for Guardant told Inside Precision Medicine, “Our current focus is on ensuring the approval and successful launch of the Shield test, with an initial focus on eligible adults age 65 and older across the U.S. who are enrolled in Medicare. In parallel, we are continuing to optimize and improve the performance of the Shield test, with the goal of upgrading the test post-approval.”
This week also, Guardant announced that the Molecular and Clinical Genetics Panel of the U.S. The Food and Drug Administration (FDA)’s Medical Devices Advisory Committee strongly recommended FDA approval of the Shield blood test for these types of patients.
“The advisory committee’s strong support for the approval of Shield reinforces the crucial role that a blood test option can have in improving CRC screening rates for those at average risk,” said AmirAli Talasaz, Guardant Health co-CEO. “Despite the importance of detecting colorectal cancer early, there are notable barriers that can deter average-risk Americans from completing existing screening methods. Shield effectively detects cancer at an early stage when it is most treatable. Providing people with this blood test alongside other non-invasive stool tests can increase the rate of colorectal screening and potentially reduce preventable CRC deaths.”
Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S. The disease has a 91% five-year survival rate when caught at stage I (localized), but one out of three eligible Americans—50 million people—are not being screened for CRC.
Current primary non-invasive screening options include stool-based tests which have proven efficacy in detecting CRC; however, studies have consistently found that barriers such as handling stool and challenges performing the test impact adherence.
“Sadly, 76% of deaths caused by colorectal cancer occur in individuals who are not up to date with their screening,” said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and professor of medicine at Harvard Medical School. “Clinical evidence and CRC screening guidelines acknowledge the value of offering choice to individuals at average risk for CRC and highlight the role of patient preference in test selection and CRC screening completion.”
The FDA panel’s recommendation is based on Guardant’s premarket approval (PMA) application for Shield, including the results of the pivotal ECLIPSE study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study appeared in the March 2024 issue of The New England Journal of Medicine. (Chung was an author on this study.) Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. Guardant notes that this performance is within range of existing stool-based tests used as primary CRC screening options, in which overall sensitivity ranges from 67% to 92%.
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