The US Food and Drug Administration (FDA)’s Medical Devices Advisory Committee has recommended the approval of the Guardant Health’s Shield blood test for colorectal cancer (CRC).
Shield is a qualitative, in vitro diagnostic test designed to identify CRC-derived alterations in cell-free DNA obtained from blood collected using the Guardant Blood Collection Kit.
The Molecular and Clinical Genetics Panel of the FDA advisory committee has suggested Shield for CRC screening in adults aged 45 and above with an average risk for the disease.
The panel members voted on three questions related to the usage of Shield in patients meeting the specified criteria in the proposed indication.
They voted 8 to 1 in favour, affirming that there is reasonable assurance of Shield’s safety and 6 to 3 in favour, indicating reasonable assurance of Shield’s effectiveness.
In addition, the panel voted 7 to 2 in favour, agreeing that the benefits of Shield outweigh its risks.
According to Guardant Health, the recommendation reflects the advisory committee panel’s consensus on Shield’s safety and effectiveness within its proposed intended use.
It also shows that their conclusion that its benefits as a primary non-invasive screening option outweigh the potential risks.
The FDA is anticipated to decide on Shield’s approval later this year.
Guardant Health co-CEO AmirAli Talasaz said: “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.
“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.”
The panel’s recommendation was driven by Guardant Health’s premarket approval (PMA) application for Shield, which includes findings from the ECLIPSE study.
ECLIPSE evaluated the test’s performance in detecting CRC among average-risk adults.
According to the results, Shield demonstrated an 83% sensitivity for CRC detection, along with a 90% specificity for advanced neoplasia.
The data aligns with existing stool-based tests which generally show an overall sensitivity ranging from 67% to 92%.
Earlier this week, Guardant Health received the European Union’s (EU) In Vitro Diagnostic Regulation (IVDR 2017/746) for its Guardant360 CDx liquid biopsy test.
