Guardant Health has secured the US Food and Drug Administration (FDA) approval for its Shield blood test as a primary screening option for colorectal cancer (CRC).
Shield is a non-invasive screening test intended to detect alterations that are associated with CRC in the blood. It has received approval for use in adults aged 45 years and above at average risk of the disease.
The move marks the first time a blood test has been approved by the FDA for CRC screening.
The approval allows healthcare providers to offer Shield as a primary screening method, similar to other non-invasive options.
Since its commercial launch as a laboratory-developed test (LDT) in May 2022, adherence rates have exceeded 90%, indicating high patient compliance.
This contrasts with the 28%-71% completion rate for other screening methods such as colonoscopies or stool tests.
Shield offers a convenient alternative that can be administered during routine office visits without the need for special preparations or dietary changes.
The FDA's decision was based on the ECLIPSE study, which involved more than 20,000 patients across 37 US states.
The study showed that Shield has an 83% sensitivity for CRC detection and 90% specificity for advanced neoplasia, aligning with the performance of other non-invasive screening methods.
Available by prescription, the Shield test is expected to be covered for Medicare beneficiaries.
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.”
In May 2024, the Medical Devices Advisory Committee for the FDA voted in favour of approving Shield as a screening test for CRC, despite concerns over false negative results.
