Guardant Health Receives ADLT Status From CMS for Shield Blood Test (Guardant Health)

Guardant Health announced that its Shield™ blood test for colorectal cancer (CRC) screening has received Advanced Diagnostic Laboratory Test (ADLT) status from CMS (Centers for Medicare & Medicaid Services), following its FDA approval in July 2024 as the first blood-based CRC screening test. This designation confirms the test’s innovative value and enables market-based Medicare pricing, with an initial reimbursement set at $1,495 starting April 1, 2025, for a nine-month period.