FDA Advisory Committee Strongly Recommends Approval For Guardant Health Blood Test For Colorectal Cancer

Panel recommends approval of Shield as primary non-invasive screening option in adults aged 45 and older at average risk for the disease

On May 23, the U.S. Food and Drug Administration (FDA)’s Medical Devices Advisory Committee strongly recommended FDA approval of the Guardant Health blood test for colorectal cancer (CRC) screening, Shield™. In a majority recommendation, the Molecular and Clinical Genetics Panel strongly recommended the CRC screening blood test as a primary non-invasive screening option in adults aged 45 and older who are at average risk for the disease.

The recommendation signals the advisory committee panel’s consensus on Shield’s safety and effectiveness with its proposed intended use, and their conclusion that its benefits as a primary non-invasive screening option outweigh any potential risks. The committee offers valuable perspective and non-binding recommendations for the FDA to factor in alongside other considerations during approval decisions. The FDA is expected to decide whether to approve Shield later this year.

“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, co-CEO of Guardant Health. “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.”

The advisory committee panel members voted on three questions regarding the use of Shield in patients who meet the criteria specified in the proposed indication. They voted 8 to 1 favorably that there is reasonable assurance Shield is safe, 6 to 3 favorably that there is reasonable assurance Shield is effective, and 7 to 2 favorably that the benefits of Shield outweigh its risks.

Screening for Colorectal Cancer through Blood Tests

Colorectal cancer is the second-leading cause of cancer-related deaths in the U.S.² yet has a 91% five-year survival rate when caught at stage I (localized).³ Despite this, one out of three eligible Americans – 50 million people – are not being screened for CRC.⁴ Current primary non-invasive screening options include stool-based tests, such as fecal immunochemical 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.^5,6,7,8 Shield offers patients a choice that can be completed with a simple blood draw during a routine office visit.

“Sadly, 76% of deaths caused by colorectal cancer occur in individuals who are not up to date with their screening,”⁹ 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.”

About Shield, the Blood Test for Colorectal Cancer Screening

The 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, published in the March 2024 issue of The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. 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%.¹⁰

The Shield test is a qualitative in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Blood Collection Kit. Shield is intended for colorectal cancer screening in individuals at average risk of the disease, aged 45 years or older. Patients with an “Abnormal Signal Detected” may have colorectal cancer or advanced adenomas and should be referred for colonoscopy evaluation. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. The test is performed at Guardant Health, Inc.

For more information about Shield for CRC screening, visit BloodBasedScreening.com.