Guardant Health, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) approved Advanced Diagnostic Laboratory Test (ADLT) status for its Shield blood test for colorectal cancer (CRC) screening. This designation is a significant regulatory milestone.
The U.S. Food and Drug Administration (FDA) approved Shield in July 2024 as the first blood test for primary CRC screening, and Medicare already covers the test. ADLT status typically leads to more favorable and predictable reimbursement rates.
This approval reinforces the clinical utility and innovation of the Shield test, providing a strong foundation for its commercial adoption and market penetration. It ensures stable reimbursement, which is crucial for scaling the screening business.
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