Guardant Health and Collaborators to Present Over 19 Studies Demonstrating Role of Liquid Biopsy in Advancing Precision Oncology at 2025 ASCO Annual Meeting

• Plenary session to highlight use of Guardant360 CDx test in detecting emerging ESR1 mutations during first line endocrine therapy in advanced breast cancer in Phase 3 SERENA-6 trial
• Oral session to feature largest study evaluating tissue-free epigenomic-based molecular residual disease (MRD) detection in colon cancer using Guardant Reveal

PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present data from more than 19 studies, including a landmark plenary session on the Phase 3 SERENA-6 trial, demonstrating the critical role of Guardant liquid biopsy tests in cancer screening, therapy selection and recurrence monitoring at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago.

Featured presentations demonstrate the use of Guardant’s portfolio of blood tests, real-world data and AI to identify genomic and epigenomic biomarkers that can inform treatment decisions across a variety of solid tumor types. Studies also highlight new capabilities of the Guardant360 Liquid test to identify molecular tumor type in carcinomas of unknown primary and confirm the absence of actionable biomarkers, both enabled by the Guardant Infinity™ smart liquid biopsy platform, Presentation highlights include:

• Abstract LBA4 plenary session demonstrating the use of the Guardant360® CDx test in detecting emergent ESR1 mutations during first-line endocrine-based therapy and ahead of disease progression in patients with HR+/HER2- advanced breast cancer in the Phase 3 SERENA-6 trial
• Abstract 3504 oral session evaluating tissue-free epigenomic-based molecular residual disease (MRD) detection using Guardant Reveal™ in stage III colon cancer patients after surgery and prior to adjuvant therapy. This study showed a robust prognostic utility of Reveal to identify patients with poorer disease-free and overall survival in a large clinical trial cohort of over 2,000 patients with a median follow-up of 6.1 years.
• Abstract 3584 providing analytic and clinical validation of an algorithm to predict the absence of actionable mutations in ctDNA-negative colorectal and non-small cell lung cancer samples, utilizing genomic and epigenomic profiling with the Guardant360 Liquid test.
• Abstract 3073 demonstrating application of an epigenomic-based classifier to identify tumor type on liquid biopsy in cancer of unknown primary origin. Study provides validation data for the new molecular tumor type feature of Guardant360 Liquid utilizing DNA methylation signatures across thousands of cancer-specific differentially methylated regions for 14 cancer types.

“The data we and our research colleagues are presenting at ASCO demonstrate the clear and growing contribution of liquid biopsy in transforming cancer care and helping to improve patient outcomes,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “The SERENA-6 study in particular highlights how we are pushing the boundaries of what can be done with liquid biopsy in characterizing disease and potential drug efficacy, providing insights that could potentially change clinical practice.”

The full abstracts for Guardant Health and a list of all abstracts being presented at ASCO 2025 can be found on the ASCO website.

For information and updates from the conference, follow Guardant Health on LinkedIn, X (Twitter) and Facebook or visit ASCO booth #25077.

Guardant Health and collaborator presentations at ASCO

Abstract/Poster

Title (Hall A unless otherwise noted)

Product

Friday, May 30, 2:45 pm – 5:45 pm CT (Arie Crown Theater, Live Stream)
3504	Oral Abstract Session: Tissue-free circulating tumor DNA assay and patient outcome in a phase III trial of FOLFOX-based adjuvant chemotherapy (Alliance N0147)	Guardant Reveal

Saturday, May 31, 9:00 am – 12:00 pm CT
3584/253	Analytic and clinical validation of a negative prediction algorithm for actionable mutations utilizing genomic and epigenomic profiling in cfDNA	Guardant360 Liquid
4200/490	Circulating tumor DNA-based genomic profiling and real-world outcomes in cancer of unknown primary (CUP)	Guardant360 Liquid GuardantINFORM

Saturday, May 31, 1:30 pm – 4:30 pm CT
8528/8	Genomic and circulating tumor DNA landscape in young-onset non-small cell lung cancer	Guardant360 Liquid
8642/122	Use of targeted therapy, healthcare costs, and survival with large panel testing, narrow testing, or no molecular testing in patients with metastatic non-small cell lung cancer (mNSCLC)	Guardant360 Liquid Guardant360 CDx
10550/275	Validation of a plasma cell-free DNA methylation-based multi-cancer detection test	Shield MCD

Sunday, June 1, 2:41 pm – 2:53 pm CT (Plenary Session, Hall B1, Live Stream)
LBA4	Oral Clinical Science Symposium: Camizestrant + CDK4/6 inhibitor (CDK4/6i) for the treatment of emergent ESR1 mutations during first-line (1L) endocrine-based therapy (ET) and ahead of disease progression in patients (pts) with HR+/HER2– advanced breast cancer (ABC): Phase 3, double-blind ctDNA-guided SERENA-6 trial	Guardant360 CDx

Sunday, June 1, 4:30 pm – 6:00 pm CT (Arie Crown Theater, Live Stream)
1012	Oral Clinical Science Symposium: Assessment of ctDNA somatic homologous recombination deficiency (HRD) in triple-negative breast cancer (TNBC) from SWOG S1416 trial	Guardant OMNI

Monday, June 2, 9:00 am – 12:00 pm CT
1052/31	Circulating tumor DNA (ctDNA)-based minimal residual disease (MRD) measured by Guardant Reveal in patients (pts) with HER2-positive (HER2+) metastatic breast cancer (mBC) with long-term disease control on first-line trastuzumab-pertuzumab	Guardant Reveal
1075/54	Use of baseline plasma circulating tumor DNA (ctDNA) to predict duration of endocrine therapy (ET) and CDK4/6 inhibitor (CDK4/6i) therapy (tx) and to analyze intrinsic vs acquired endocrine resistance	Guardant360 Liquid
5052/251	Evaluating the prognostic utility of cell-free (cf)DNA tumor fraction (TF) in metastatic castration-resistant prostate cancer (mCRPC)	Guardant360 Liquid
5053/252	Real world outcomes for patients with metastatic castration resistant prostate cancer (mCRPC) and AR T878A alterations treated with enzalutamide	GuardantINFORM
5077/276	Real-world prevalence of homologous recombination repair alterations (HRRa) and poly (ADP-ribose) polymerase inhibitor (PARPi) use/outcomes in patients (pts) with metastatic prostate cancer (mPC) by race and ethnicity	GuardantINFORM
5086/285	Association between epigenomic biomarkers and baseline clinical characteristics in patients with mCRPC treated with rucaparib in TRITON2	Guardant Infinity

Monday, June 2, 1:30 pm – 4:30 pm CT
3073/388	Application of an epigenomic-based classifier to identify cancer signal of origin on liquid biopsy in cancer of unknown primary cases	Guardant360 Liquid
3074/389	HRD status prediction in patients with advanced breast, prostate, ovarian and pancreatic cancers in a liquid biopsy assay	Guardant360 Liquid

Tuesday, June 3, 8:30 am CT
5512	Oral Abstract Session: Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer: Longitudinal changes in circulating tumor DNA	Guardant Infinity

Online Abstracts
e20536	Accelerating treatment decisions with liquid biopsy NGS in non-small cell lung cancer	Guardant360 Liquid
e13084	Targeted agents for the treatment of hormone receptor–-positive, human epidermal growth factor receptor 2–negative metastatic breast cancer (HR+/HER2- MBC) with co-alterations in ESR1 and AKT pathway: A retrospective analysis	Guardant360 Liquid

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.