• LIBERATE Study: Guardant Reveal showed high sensitivity and 100% positive predictive value for relapse

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced results from the LIBERATE study published in ESMO Open. The results in the peer-reviewed manuscript demonstrate the clinical validity and high performance of Guardant Reveal, the company’s minimal residual disease (MRD) blood test, in predicting recurrence in patients with early-stage breast cancer. Guardant Reveal uses epigenomic (methylation) analysis to detect circulating tumor DNA (ctDNA) in a patient’s blood without the need for a tissue sample.

The LIBERATE study retrospectively analyzed 290 blood samples from 95 patients who were diagnosed with early-stage ER+/HER2- or triple negative breast cancer undergoing chemotherapy prior to surgery, half of whom had localized disease with no lymph node involvement. Nearly 40% had minimal or no residual tumor by pathologic assessment following neoadjuvant chemotherapy.

Key findings include:

• High Sensitivity and Specificity: Guardant Reveal demonstrated 100% sensitivity for distant recurrence in patients with ER+/HER2- breast cancer (which represents about 70% of all breast cancers), and 71% overall, with 100% specificity and 100% positive predictive value for relapse.
• Significant Prognostic Power: Detection of ctDNA post-operatively was significantly prognostic for event-free survival (EFS), with median lead time of 152 days (range: 15-748 days) ahead of clinical recurrence (P < 0.0001).
• Nearly 100% of All Samples Evaluable: All patients with post-operative blood samples had MRD results available from Reveal, highlighting the power of a tissue-free MRD test among patients receiving neoadjuvant therapy, particularly the large percentage who have minimal to no tumor found at surgery.

"This study underscores the clinical validity, robust prognostic value and high specificity of Guardant Reveal in identifying breast cancer patients at elevated risk of recurrence without the need for a tissue sample," said Craig Eagle, M.D., Guardant Health chief medical officer. "These findings reinforce the critical role Reveal can achieve in clinical decision-making, potentially transforming neoadjuvant and post-treatment surveillance strategies and improving patient outcomes."

This publication adds to the growing body of evidence of Reveal’s strong performance in early-stage breast cancer. Earlier this year, a peer-reviewed publication in Clinical Cancer Research focused on stage II and III triple negative breast cancer demonstrated 83% sensitivity for metastatic recurrence and 99.5% sample-level specificity. Post-surgical ctDNA detection was prognostic for shorter recurrence-free interval (P < 0.0001). Additionally, ctDNA detection at the post-neoadjuvant, presurgical time point was associated with a shorter recurrence-free interval in patients with residual disease at surgery (P < 0.0001).

The full manuscript in ESMO Open is available here.

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, 2024, and in its other 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.

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