Guardant Health’s Shield Test Receives Key Medicare Approval, Expanding Access to Non-Invasive Cancer Screening
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Guardant Health Inc. (NASDAQ: GH), a leader in precision oncology, has reached a pivotal milestone in the advancement of cancer diagnostics. The company’s Shield™ blood test, developed for colorectal cancer (CRC) screening, has been granted Advanced Diagnostic Laboratory Test (ADLT) status by the Centers for Medicare & Medicaid Services (CMS)—a designation that enhances reimbursement and signals strong clinical value.
Shield is the first blood-based screening test for CRC to receive ADLT status, marking a breakthrough in non-invasive diagnostic options. The test, which gained FDA approval in July 2024, is designed for individuals aged 45 and older, offering an alternative to traditional screening methods such as colonoscopy or stool-based tests. Its ease of use and innovative technology aim to increase screening rates and encourage earlier detection.
With this CMS recognition, starting April 1, 2025, Medicare will reimburse $1,495 per test during the nine-month initial ADLT pricing period. The reimbursement reflects the test’s novel approach and its potential to provide clinically meaningful insights not available through current standard tests.
During this initial period, Guardant Health will collect data on private-payer payment rates. CMS will use this information to establish a median market-based reimbursement rate, effective from January 1, 2026, through December 31, 2027.
Amir Ali Talasaz, co-CEO of Guardant Health, highlighted the importance of the ADLT status and its impact on patient care. “This designation allows us to significantly expand access to Shield, particularly for Medicare beneficiaries,” he said. “By making non-invasive screening more accessible, we can help improve early detection and outcomes for colorectal cancer across the country.”
Colorectal cancer remains a major health concern in the U.S. and globally. Despite the availability of screening tools, many eligible individuals remain unscreened, often due to the invasiveness or inconvenience of existing methods. Shield’s blood-based approach may reduce barriers to screening and increase compliance—an important public health goal given that early detection significantly improves survival rates.
As Guardant Health continues to invest in expanding its commercial infrastructure, the broader medical community—and particularly patients eligible for CRC screening—stand to benefit from greater access to innovative testing solutions that support proactive healthcare and early intervention.
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