Blood Test Approved by FDA for Screening for Colorectal Cancer

Guardant’s Shield blood test was approved¹ by the FDA on July 29 for use in screening for colorectal cancer (CRC) among adults 45 years and older at average risk. The approval marks the first time that a blood test has been approved by the FDA for use as a primary screening tool for CRC, which could expand screening availability.

CRC often has a good prognosis if caught early but remains the second-leading cause of cancer-related death in the US, with total number of deaths in 2024 estimated to be 53,000. Patients not being up to date on their screening is the primary cause of 3 of 4 deaths due to CRC, with the US screening rate at only 59% and 1 of 3 eligible Americans not completing screening due to the invasive and unpleasant traditional screening methods.

The Shield blood test aims to address those barriers to screening. The laboratory-developed test launched in May 2022 and had an overall adherence of 90% compared with 28% to 71% for other screening methods. The Shield test can be completed during a routine office visit through a blood draw, which would allow easier completion. The blood test will also meet the requirements for coverage by Medicare, which makes it a desirable option for the demographic of patients who need it most.

The Shield blood test provides an alternate method for screening for colorectal cancer | Image credit: angellodeco - stock.adobe.com

The approval comes as a response to the positive results of the ECLIPSE study. The New England Journal of Medicine published the results in March,² with the main takeaways being that the test had an 83.1% sensitivity rate (95% CI, 72.2%-90.3%), which meant that 83.1% of patients with CRC detected by a colonoscopy had a positive result when using Shield.³ Shield also had an 89.6% specificity for advanced neoplasia (95% CI, 88.8%-90.3%). The FDA's advisory committee panel provided a strong recommendation for approval in May.

The blood test is designed to detect CRC from cell-free alterations in the DNA of the blood collected by the kit. If an abnormal signal is detected, patients may be recommended to receive a colonoscopy. Patients at a higher risk of CRC should use colonoscopy, as the blood test does not act as a replacement.³

The blood test will be available through a prescription by a doctor or health care professional and will be covered by Medicare for all beneficiaries.

“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 colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable,” AmirAli Talasaz, Guardant Health co-CEO, said in a press release.¹

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. 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. Chung DC, Gray DM II, Singh H, et al. A cell-free DNA blood-based test for colorectal cancer screening. N Engl J Med. 2024;390:973-983. doi:10.1056/NEJMoa2304714
3. Wahner A. FDA advisory committee recommends approval of Shield blood test for CRC detection in average-risk adults. May 24, 2024. Accessed July 29, 2024. https://www.onclive.com/view/fda-advisory-committee-recommends-approval-of-shield-blood-test-for-crc-detection-in-average-risk-adults