Guardant Health has secured a significant milestone that strengthens its position in the colorectal cancer (CRC) monitoring market. Palmetto GBA, a Medicare administrative contractor overseeing the Molecular Diagnostics Services program (MolDX), has approved Medicare coverage for the Guardant Reveal test. This decision expands the test’s eligibility to include surveillance for disease recurrence in CRC patients following curative intent therapy.
Guardant Reveal is a groundbreaking blood test that operates on Guardant’s Smart Liquid Biopsy platform. It employs epigenomic (methylation) analysis to detect circulating tumor DNA (ctDNA), a key indicator of minimal residual disease (MRD). By identifying potential cancer recurrence at an early stage, this test empowers clinicians with critical insights to guide post-treatment care strategies, improving patient outcomes.
Previously, Medicare coverage for Guardant Reveal was restricted to the early post-surgical setting. The expanded coverage now extends to ongoing CRC surveillance, allowing more patients to benefit from its non-invasive, tissue-free approach. Unlike tumor-informed MRD tests that require a physical tissue sample, Guardant Reveal only necessitates a simple blood draw, making it a more accessible and patient-friendly option.
Investment firm William Blair, which holds an Outperform rating on Guardant Health, sees this coverage decision as a major positive catalyst for the company’s stock. Analyst Andrew Brackmann highlights that with reimbursement secured, the company can now fully leverage its market opportunities rather than limiting testing volumes to manage financial constraints. This shift is expected to drive increased adoption and revenue growth.
Beyond expanded coverage, the company is also benefiting from ongoing workflow enhancements that reduce costs. These improvements are anticipated to make Guardant Reveal gross margin positive later this year. With rising adoption rates and greater reimbursement support, Guardant Health is well-positioned to exceed its projected clinical volume growth target of over 20% in 2025, reinforcing its leadership in the liquid biopsy space.
Guardant Health continues to advance precision oncology with innovative blood-based tests that improve cancer detection and monitoring, ultimately enhancing patient care and clinical decision-making.
EDX Medical Group Plc (AQSE:EDX) is a global specialist in digital clinical diagnostics; developing and supporting high-performance products and services to provide cost-effective prediction of disease risk, inform clinical decision-making, enable personalised healthcare and accelerate the development of new medicines for cancer, neurology, heart disease and infectious diseases.
