Medicare To Reimburse Guardant Health's Shield Colorectal Cancer Test, Analyst Expects $10M In Revenue

Group 1 - The Centers for Medicare & Medicaid Services (CMS) approved the Advanced Diagnostic Laboratory Test (ADLT) status for Guardant Health's GH Shield blood test for colorectal cancer screening [1] - The FDA approved the Shield test in July 2024 as the first blood test for primary colorectal cancer screening, and Medicare already covers the test [1] - Starting April 1, the Shield test will be reimbursed at $1,495 during the initial nine-month ADLT period [1] Group 2 - During the initial ADLT period, Guardant Health will collect and submit private-payer payment rate data for the Shield test, with the median rate to be used by CMS for Medicare pricing starting January 1, 2026 [2] - The median rate will determine the payment amount for the Shield test from January 1, 2026, to December 31, 2027 [2] Group 3 - Palmetto GBA granted coverage for the Guardant Reveal test to monitor disease recurrence in colorectal cancer patients following curative intent therapy [3] - Securing ADLT status is seen as key to increasing average selling prices (ASPs) beyond previous guidance assumptions [3] - Analyst Andrew Brackmann views the update favorably and maintains an Outperform rating for Guardant Health [3] Group 4 - The ADLT status and price increase were not included in Shield's previous revenue guidance, which projected annual screening revenue between $25 million and $30 million, with volumes of 45,000 to 50,000 [4] - The increase in Medicare reimbursement from $920 to $1,495 could potentially add around $10 million in additional revenue, assuming the same mix as previously estimated [4] Group 5 - Guardant Health's stock price increased by 14.5% to $41.04 following the news [5]