Guardant Health’s Shield blood test gains ADLT status, strengthening Medicare coverage for colorectal cancer screening

Guardant Health, Inc. has received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) for its Shield blood test, an FDA-approved screening tool for colorectal cancer (CRC). This designation underscores the Shield test’s clinical innovation and ensures a structured Medicare reimbursement model, reinforcing its role in expanding access to non-invasive cancer screening.

The U.S. Food and Drug Administration (FDA) approved Shield in July 2024, making it the first blood test for primary colorectal cancer screening in average-risk individuals aged 45 and older. With ADLT status secured, Medicare reimbursement for Shield will be set at $1,495 per test for the initial nine-month period, which begins April 1, 2025.

What Does ADLT Status Mean for the Shield Blood Test?

The CMS decision validates Shield as an innovative diagnostic tool that provides unique clinical insights, qualifying it for ADLT status, a designation reserved for FDA-approved tests that offer novel medical data unavailable through other methods.

The Shield blood test is designed to improve early colorectal cancer detection rates by providing a convenient, non-invasive alternative to traditional stool-based or colonoscopy-based screening methods. This approach aims to address low adherence rates associated with conventional CRC screening by offering a blood-based option that aligns with routine check-ups.

How Will Medicare Pricing for the Shield Test Evolve?

During the initial ADLT pricing period, Guardant Health will collect and analyze private-payer payment data, submitting the findings to CMS. The median private-payer rate will then be used to set the final Medicare reimbursement price, which will take effect on January 1, 2026, and remain in place until December 31, 2027.

This market-driven pricing approach ensures that reimbursement for the Shield blood test reflects its value and adoption within the broader healthcare system. Analysts expect that this model will influence private insurance companies, potentially expanding commercial coverage for the test beyond Medicare.

How Does ADLT Status Impact the Future of CRC Screening?

The ADLT designation not only secures a favorable Medicare reimbursement structure but also signals growing recognition of blood-based cancer screening tests. Industry experts believe this could drive greater adoption of Shield among healthcare providers and encourage broader insurance coverage, particularly as CRC screening guidelines continue to evolve.

Guardant Health has already reported strong demand for Shield among Medicare-covered patients, indicating that the ADLT status could further accelerate adoption rates. With colorectal cancer being the second leading cause of cancer-related deaths in the United States, increasing access to less invasive screening options could play a pivotal role in improving early detection and survival rates.

How Will Guardant Health Expand Shield’s Market Presence?

With a structured Medicare reimbursement plan in place, Guardant Health is expected to expand its commercial efforts to increase Shield’s market penetration. This includes strengthening relationships with primary care providers, expanding educational initiatives about blood-based CRC screening, and working with private insurers to establish broader reimbursement agreements.

The company is likely to leverage the ADLT pricing framework as a precedent for future discussions with commercial payers, potentially influencing coverage decisions that extend beyond Medicare populations. Analysts suggest that the test’s pricing stability and Medicare approval could position it as a preferred screening option for individuals who have historically avoided traditional CRC screening methods.

What Does This Mean for the Broader Cancer Screening Market?

The Shield blood test enters a competitive colorectal cancer screening market, which includes stool-based tests and colonoscopy procedures. While traditional methods remain the gold standard, blood-based screening is gaining traction as an alternative for patients resistant to conventional options.

Guardant Health’s success in securing ADLT status places Shield in a strong position to compete within the $20 billion CRC screening industry. The structured Medicare reimbursement model, combined with its FDA approval and growing provider adoption, could significantly influence future colorectal cancer screening guidelines.

Guardant Health’s achievement in obtaining ADLT status for the Shield blood test marks a significant milestone in the evolution of colorectal cancer screening. By securing structured Medicare pricing, the company has reinforced Shield’s value as a non-invasive, clinically validated screening option. With increasing support from healthcare providers and potential expansion into commercial insurance markets, the Shield test is poised to play a transformative role in improving CRC detection rates.

As adoption grows and data accumulates on Shield’s real-world impact, Guardant Health’s market positioning in the precision oncology sector will continue to strengthen, potentially paving the way for further innovation in blood-based cancer diagnostics.