Precision oncology company Guardant Health has obtained approval from the US Food and Drug Administration (FDA) to use its Shield blood test for the screening of colorectal cancer (CRC).
Shield is a non-invasive, blood-based screening test for identifying alterations related to colorectal cancer in the bloodstream.
The test is now approved in the US as a primary screening option in adults aged 45 and older who are at average risk of colorectal cancer.
The approval makes Shield the first blood test to receive FDA authorisation as a primary screening option for this type of cancer. It will enable healthcare providers to use it alongside other non-invasive methods recommended in screening guidelines.
According to Guardant Health, Shield is the first colorectal cancer screening blood test to qualify for Medicare coverage.
The blood test was commercially launched as a laboratory-developed test (LDT) in May 2022.
Shield allows primary care physicians to administer it with a simple blood draw during a routine office visit. This avoids the special preparation, dietary changes, and discomfort associated with colonoscopy and stool test.
Guardant Health co-CEO AmirAli Talasaz said: “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.
“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.”
The FDA’s approval of Shield follows a strong recommendation from the regulator’s Medical Devices Advisory Committee in May 2024. It was based on the results of the ECLIPSE study, a registrational trial involving over 20,000 patients, which assessed the test’s performance in detecting colorectal cancer in average-risk adults.
The results of the study showed 83% sensitivity for colorectal cancer detection and 90% specificity for advanced neoplasia.
Shield can be obtained by prescription from a doctor or other healthcare professional and is anticipated to be covered for eligible Medicare beneficiaries.
Coverage through commercial insurance could grow as the American Cancer Society and the US Preventive Services Task Force (USPSTF) are anticipated to include Shield in their future guidelines.
In May 2024, Guardant Health obtained certification from the European Union’s In Vitro Diagnostic Regulation (IVDR 2017/746) for its Guardant360 CDx liquid biopsy test. The TÜV SÜD Product Service certification covers tumour mutation profiling for individuals with any type of solid cancerous tumour.
