Guardant Health has announced results from the ECLIPSE study, demonstrating the effectiveness of its Shield blood-based test for colorectal cancer (CRC) screening.
Involving more than 20,000 participants, the study compared the performance of the Shield test to traditional screening colonoscopies.
It included over 200 clinical trial sites in rural and urban communities across 34 states in the US.
The Shield test operates by detecting CRC signals in the bloodstream from DNA shed by tumours, known as circulating tumour DNA (ctDNA).
According to the study’s findings, the Shield test identified 83% of individuals with CRC, with an 88% detection rate for pathology-confirmed Stages I-III CRC.
Sensitivity rates for the Shield test varied by stage, with 65% for pathology-confirmed Stage I and 55% for clinical Stage I. Stages II, III, and IV saw a 100% sensitivity rate.
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These results align with the performance of other non-invasive CRC screening methods recommended in guidelines, which have an overall sensitivity range of 74% to 92%.
Following the ECLIPSE study, Guardant Health submitted a premarket approval application to the FDA for the test, incorporating key data from the research.
The study is planned to be published in The New England Journal of Medicine.
Guardant Health co-CEO AmirAli Talasaz said: “We believe the publication of the ECLIPSE study in The New England Journal of Medicine, one of the world’s leading medical journals, is an endorsement of the quality of our clinical data and the potential value of the Shield test.”
The test’s high sensitivity for CRC detection and its adherence to real-world use suggest that it could potentially identify more CRC cases at a curable stage compared to traditional screening methods.
Earlier this year, Guardant Health signed a deal to promote its range of liquid and tissue biopsy tests for cancer screening across the Middle East and North African markets.
