Shield Blood Test Receives FDA Approval for CRC Screening in Adults

The FDA has approved Guardant Health’s Shield blood test for colorectal cancer (CRC) screening in adults 45 years of age and older who are at average risk for the disease. Shield is the first blood test to receive FDA approval as a primary screening option for CRC and the first blood test for CRC screening that meets Medicare coverage requirements.¹

The regulatory decision was supported by findings from the observational ECLIPSE study (NCT04136002) and follows a May 2024 strong recommendation for approval of the test by the FDA’s Medical Devices Advisory Committee for CRC screening in adults 45 years of age and older who are at average risk of developing the disease. Data from ECLIPSE demonstrated that Shield displayed a CRC sensitivity rate of 83.1% (95% CI, 72.2%-90.3%) and an 89.6% advanced neoplasia specificity rate (95% CI, 88.8%-90.3%) in 7861 patients who met the eligibility criteria. The performance of the test places it within the sensitivity range of current guideline-recommended noninvasive screening methods, which range from 67% to 92%.^2,3

“The persistent gap in CRC screening rates shows that the existing screening options do not appeal to millions of people,” Daniel Chung, MD, medical co-director of the Center for Cancer Risk Assessment and director of the High-Risk GI Cancer Clinic at Massachusetts General Hospital, as well as a professor of medicine at Harvard Medical School, both in Boston, said in a news release.¹ “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.”

Shield was developed over a more than 10-year span in a collaboration between Guardant Health and leading global health organizations. The overall adherence rate for the noninvasive test has been over 90% since the commercial introduction of the laboratory-developed test version in May 2022. Research has shown that patients who are prescribed other screening methods, including colonoscopy or a stool test, have adherence rates ranging between 28% and 71%. Shield is administered via a simple blood draw during a routine office visit, offering patients a screening method that does not necessitate the special preparation, dietary changes, time, and discomfort associated with traditional screening methods.¹

ECLIPSE was a nonrandomized, prospective, multisite study that enrolled patients aged 45 to 84 years who were intended to undergo screening colonoscopy. Patients needed to be considered by a physician to be of average risk for CRC, be willing to consent to blood draw pre-bowel preparation administration prior to undergoing colonoscopy within 60 days of the date of the investigational blood draw, and be willing to undergo 2 years of follow-up. The primary outcomes were sensitivity of CRC detection and advanced neoplasia detection; secondary outcomes included the positive and negative predictive values of CRC detection, as well as sensitivity and specificity of advanced adenoma detection.⁴

According to Guardant Health, commercial insurance coverage for patients eligible for CRC screening will continue to expand following anticipated future guideline inclusion of the Shield test by the American Cancer Society and the United States Preventive Services Task Force.¹

“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. Shield can help improve CRC screening rates so we can detect more cancers at an early stage, when they are treatable,” AmirAli Talasaz, PhD, co-chief executive officer, and director of Guardant Health, added in the news release.¹ “We are now getting ready to launch this test in the near future and 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.”

References

1. Guardant Health’s Shield blood test approved by FDA as a primary screening option, clearing path for Medicare reimbursement and a new era of colorectal cancer screening. News release. Guardant Health, Inc. July 29, 2024. Accessed July 29, 2024. https://investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Healths-Shield-Blood-Test-Approved-by-FDA-as-a-Primary-Screening-Option-Clearing-Path-for-Medicare-Reimbursement-and-a-New-Era-of-Colorectal-Cancer-Screening/default.aspx
2. FDA advisory committee panel strongly recommends approval of Shield blood test for colorectal cancer screening as a primary non-invasive screening option. News release. Guardant Health, Inc. May 23, 2024. Accessed July 29, 2024. https://investors.guardanthealth.com/press-releases/press-releases/2024/FDA-Advisory-Committee-Panel-Strongly-Recommends-Approval-of-Shield-Blood-Test-for-Colorectal-Cancer-Screening-as-a-Primary-Non-Invasive-Screening-Option/default.aspx
3. Chung DC, Gray DM 2nd, Singh H, et al. A cell-free DNA blood-based test for colorectal cancer screening. N Engl J Med. 2024;390(11):973-983. doi:10.1056/NEJMoa2304714
4. Evaluation of the ctDNA LUNAR test in an average patient screening episode (ECLIPSE). ClinicalTrials.gov. Updated July 3, 2024. Accessed July 29, 2024. https://clinicaltrials.gov/study/NCT04136002