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Guardant Health Expands Tissue-Free Reveal Test to Include Late-Stage Therapy Response Monitoring

via Business Wire
  • New Guardant Reveal offering provides oncologists with tissue-free solution to monitor treatment response and detect early disease progression with unprecedented speed and sensitivity
  • Reveal is clinically validated in confirming effective therapies earlier and optimizing treatment faster in patients with advanced cancer

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the expansion of its Guardant Reveal® blood test to include late-stage therapy response monitoring for patients with solid tumors. Guardant Reveal tracks more than 20,000 epigenomic (methylation) signals to measure changes in circulating tumor DNA (ctDNA) levels in a patient’s blood to predict outcomes sooner than imaging without the need for a tissue sample.

Building on Reveal’s proven performance in minimal residual disease (MRD) detection, the expanded offering leverages Guardant’s proprietary epigenomic technology powered by the Guardant Infinity Smart Platform to predict therapy response across all therapy classes, including immunotherapy and chemotherapy, which most patients with advanced-stage cancer receive at some point during their treatment. Guardant Reveal therapy response monitoring can be initiated at any time during a patient’s treatment journey, offering clinicians flexibility and actionable insights in just seven days.

“Guardant Reveal continues to redefine what’s possible in liquid biopsy for oncologists and patients, creating a new paradigm for therapy monitoring,” said Helmy Eltoukhy, Guardant Health Chairman and co-CEO. “By integrating therapy response monitoring into Guardant Reveal, we now have an end-to-end monitoring test built on the Infinity Smart Platform that simplifies clinical workflows and empowers providers to make faster, more informed decisions with just a simple blood draw.”

In addition to being the most clinically validated tissue-free test on the market, the expansion of Guardant Reveal to late-stage therapy response monitoring is supported by recent clinical evidence. The first clinical-validation study of pan-cancer chemotherapy monitoring published last week in The Journal of Liquid Biopsy showed that Guardant Reveal predicts long-term patient benefit up to 18 months earlier than standard clinical measures.

Additionally, findings from the RADIOHEAD study, a large, clinical validation study focused on immune checkpoint inhibitor response monitoring across multiple solid tumor types, showed Guardant Reveal successfully detected responses to immunotherapy up to 5 months earlier than standard imaging and identified decreases in tumor fraction were strongly associated with improved patient outcomes.

Alongside the Reveal expansion, a new universal ordering option launched today will allow physicians to order Guardant’s comprehensive portfolio of products in a single-click, providing physicians with more flexibility and reducing administrative burden to support seamless patient management from diagnosis through all stages of treatment.

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.

Guardant Health 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. 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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