Guardant Health's Colorectal Cancer Monitoring Test Gains Medicare Coverage

Guardant Health (NASDAQ: GH), a leading precision oncology company, has received a significant boost with Medicare's expanded coverage for its Guardant Reveal test. The test, which monitors disease recurrence in patients with colorectal cancer (CRC) following curative intent therapy, is now covered for use in the CRC surveillance setting after curative intent treatment. This expansion builds upon the existing Medicare coverage for CRC testing in the early post-surgical setting only.

The tissue-free Guardant Reveal test uses a blood sample, making it more accessible for patients who have no tissue available or for whom tissue specimens are difficult to obtain. This includes the over 12 million cancer patients in the U.S. who are more than five years out from surgery, and the over three million who do not have tumor tissue available at all (Guardant Health, 2025).

The expanded coverage allows for more comprehensive monitoring of CRC patients, potentially identifying molecular recurrence ahead of traditional imaging methods, such as CT scans and CEA testing (Guardant Health, 2025). This earlier detection can lead to better patient outcomes and potentially reduce healthcare costs.

The expanded Medicare coverage is expected to have a significant positive impact on Guardant Health's financial projections and market share in the colorectal cancer monitoring sector. With Medicare covering a significant portion of the U.S. population, the increased market access will likely lead to a higher number of patients being tested, driving up the company's market share in the sector. The reimbursement, along with ongoing workflow improvements, is expected to make the Guardant Reveal test gross margin positive later this year, helping the company reduce cash burn and potentially exceed its clinical volume growth target of 20% or more for 2025 (Canaccord Genuity, 2025).

While the expanded coverage is a positive development for Guardant Health, the company must also address potential risks and challenges. These include false positives/negatives, competition from other companies developing blood-based tests for colon cancer, and reimbursement challenges. Guardant Health faces competition from other companies like Exact Sciences and Natera, which are also working on blood-based tests for colon cancer. Natera has launched a whole genome-based version of its test, Signatera, and plans to launch a tissue-free test for MRD in colon cancer patients (Natera, 2025). This competition could limit Guardant Health's market share and revenue growth.

In conclusion, the expanded Medicare coverage for Guardant Health's Guardant Reveal test represents a significant opportunity for the company to increase its revenue, market share, and competitive position in the colorectal cancer monitoring sector. However, the company must also address potential risks and challenges, such as false positives/negatives, competition, and reimbursement challenges, to maintain its market position and drive growth. As Guardant Health continues to innovate and adapt to the evolving landscape of precision oncology, investors should monitor the company's progress and potential developments in the colorectal cancer monitoring sector.