Guardant Health Receives Medicare Coverage for Guardant Reveal™ on Smart Liquid Biopsy™ Platform for Surveillance Testing in Colorectal Cancer Patients

• Blood test for minimal residual disease (MRD) now covered to monitor for disease recurrence after curative intent treatment
• Tissue-free approach addresses need for cancer patients who have no tissue available or for whom tissue specimens are difficult to obtain

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that Palmetto GBA, a Medicare administrative contractor that administers the Molecular Diagnostics Services program (MolDX), granted coverage for the Guardant Reveal test to monitor for disease recurrence in patients with colorectal cancer (CRC) following curative intent therapy. Guardant Reveal, which runs on Guardant’s Smart Liquid Biopsy platform, is a blood test that uses epigenomic (methylation) analysis to detect circulating tumor DNA (ctDNA), a marker of minimal residual disease (MRD), to predict cancer recurrence, helping to guide clinical decisions after surgery or chemotherapy.

As a result of this decision, the Guardant Reveal test is now covered for use in the CRC surveillance setting after curative intent treatment. This represents an expansion from the prior Medicare coverage of Guardant Reveal testing for CRC in the early post-surgical setting only.

“Utilizing ctDNA testing in the surveillance setting alongside standard of care monitoring, such as CT scans and CEA testing, has the potential to identify molecular recurrence of colorectal cancer ahead of traditional imaging,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “This important step by Medicare will make this testing more widely available to patients and support oncologists in making more informed therapeutic decisions.”

The tissue-free Guardant Reveal test uses a blood sample, in contrast to tumor-informed approaches to MRD testing, which require a healthcare provider to obtain a physical tissue specimen of the tumor. Of the 18 million total cancer patients in the U.S. who would benefit from MRD testing, less than 3% are being tested today. In addition, more than 12 million cancer patients are over five years out from surgery, making it much more difficult to obtain a tissue specimen, and data suggests more than three million do not have tumor tissue available at all.*

About Guardant Health

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2023, and any current and periodic reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.

* Sources: 1-2 Survival data from the Surveillance, Epidemiology, and End Results (SEER) Program; Tonorezos E, Devasia T, Mariotto AB, Mollica MA, Gallicchio L, Green P, Doose M, Brick R, Streck B, Reed C, de Moor JS, Prevalence of Cancer Survivors in the United States, JNCI: Journal of the National Cancer Institute, 2024; https://doi.org/10.1093/jnci/djae135. 3. Guardant analysis of Lung, CRC, Breast cancer literature incl. Hellman, 2020, Moding, 2020, Ohara, 2020, Abbosh, 2017, Tarazona, 2019, Tie, 2017, Nimeiri, 2022 (ASCO GI), Coombes, 2019, Garcia-Murillas, 2019, Parsons, 2020, Magbanua, 2021, Lipsyc-Sharf, 2022, Shaw, ASCO 2022. 4. Guardant market analysis