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Guardant Health Submits Colorectal Cancer Screening Test to FDA for Premarket Approval

NEW YORK – Guardant Health said Friday that it has submitted the final module of its premarket approval application to the US Food and Drug Administration for its Shield assay, a blood-based colorectal cancer screening test.

The company said the submission includes data from its ECLIPSE study, which enrolled approximately 20,000 average-risk adults and compared results of Guardant's Shield test to routine colonoscopy findings. In preliminary study results Shield demonstrated 83 percent sensitivity for the detection of colorectal cancer with 90 percent specificity. The test also demonstrated 13 percent sensitivity in detecting advanced adenomas.

Like several other blood-based cancer screening tests in development or on the market, Shield involves sequencing cell-free DNA and detecting cancer-associated DNA methylation signatures.

In a statement, Guardant Co-CEO AmirAli Talasaz, said Guardant believes that patient access to blood-based testing can help address underscreening, especially in underserved populations. Although colorectal cancer is the second-leading cause of cancer-related death, a third of eligible adults are not up to date with recommended screening, he said.

According to Guardant, there has been approximately 90 percent adherence among patients offered Shield since its launch as a laboratory-developed test in May 2022.