Guardant Health's Shield Test Secures ADLT Status And Medicare Approval

(RTTNews) - Guardant Health, Inc. (GH) Tuesday announced that the Centers for Medicare & Medicaid Services or CMS has granted Advanced Diagnostic Laboratory Test or ADLT status to its Shield blood test for colorectal cancer or CRC screening. Approved by the FDA in July 2024, Shield is the first blood test for primary CRC screening and is already covered by Medicare.

The ADLT designation, reserved for innovative tests providing unique clinical insights, enables a market-based pricing approach for Medicare patients. As a result, Shield will be reimbursed at $1,495 per test during an initial nine-month ADLT period starting April 1, 2025. During this time, Guardant Health will collect private-payer payment data, which CMS will use to establish a Medicare reimbursement rate effective from January 1, 2026, to December 31, 2027.

Guardant Health's co-CEO, AmirAli Talasaz, highlighted that this designation reinforces Shield's value by offering a convenient, non-invasive alternative to traditional CRC screening, which could increase screening rates and improve patient outcomes. He noted that strong adoption among Medicare-covered providers and the favorable Medicare rate will support further investment in commercial expansion.

Shield is FDA-approved for primary CRC screening in average-risk individuals aged 45 and older. More details are available at www.ShieldCancerScreen.com.

GH is currently trading at $42.73 or 19.22% higher on the Nasdaq Global Select Market.