Latest news with #GuardantReveal
Business Wire
29-07-2025
- Business
- Business Wire
New RADIOHEAD Study Validates Use of Guardant Reveal Tissue-Free Monitoring for Earlier Detection of Immunotherapy Response in Advanced Cancer
PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the first clinical readout from their collaboration in the RADIOHEAD study with the Parker Institute for Cancer Immunotherapy (PICI), a network of the largest concentration of immuno-oncology (IO) expertise in the world. The data, published today in Cancer Research Communications, a journal of the American Association for Cancer Research, found that Guardant Reveal successfully detected responses to immunotherapy across multiple solid tumor types in advanced stage cancer patients and identified non-responders more than three months—and in some cases nearly five months—before disease progression was visible by standard methods. Approximately 30% of patients with advanced-stage cancer receive immunotherapy treatment, with varying degree and duration of response. This study analyzed a large cohort of more than 500 patients with various advanced solid tumors, including lung, skin, head and neck, breast, GI, GU, and gynecologic cancers, receiving immunotherapy in a real-world setting to assess if blood-based monitoring could predict response accurately and faster than standard of care methods. The strong association found between long-term patient outcomes and changes in tumor fraction as measured with the tissue-free, methylation-based Guardant Reveal supports the use of blood-based monitoring to help predict treatment response and improve decision-making in cancer care. 'Precise serial monitoring at the molecular level provides real value to oncologists and to patients using immunotherapy,' said Craig Eagle, M.D., Chief Medical Officer at Guardant Health. 'This study shows that Guardant Reveal has the potential to revolutionize how oncologists assess patient response, identifying earlier insights that can empower them to make informed decisions faster and improve patient outcome and quality of care.' 'Our RADIOHEAD study of Guardant Reveal in advanced stage cancers provides patients with a new caliber of precision monitoring in order to create better patient outcomes,' said Tarak Mody, PhD, Chief Business Officer at PICI. 'These findings exemplify PICI's commitment to forging mission-driven partnerships to bring cutting-edge technology into clinical practice, accelerate discoveries, and advance the development of curative immune therapies for patients.' Key study findings include: The full manuscript in Cancer Research Communications 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 and follow the company on LinkedIn, X (Twitter) and Facebook. About RADIOHEAD The RADIOHEAD (Resistance Drivers for Immuno-Oncology Patients Interrogated by Harmonized Molecular Datasets) program is a pan-tumor, prospective cohort study of 1,070 immunotherapy-naïve patients receiving standard-of-care immune checkpoint inhibitor regimens. Conducted across 49 U.S. community oncology clinics, the study includes over 3,700 longitudinal blood samples collected at pretreatment, early on-treatment, and immune-related adverse event timepoints, with a focus on major immuno-oncology indications such as non-small cell lung cancer (~1,400 samples) and malignant melanoma (~500 samples). Multi-omic profiling (including circulating tumor DNA analysis, whole-exome sequencing, transcriptomics, high-dimensional immune profiling, and serum proteomics) is paired with detailed clinical and demographic data to enable deep translational insights. This comprehensive dataset provides a unique opportunity to uncover mechanisms of response, resistance, and toxicity, and to apply machine learning approaches to explore immune and disease pathways. 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.
Yahoo
09-06-2025
- Business
- Yahoo
New Study Published in ESMO Open Highlights Guardant Reveal's Performance in Detecting Minimal Residual Disease in Patients with Early-Stage Breast Cancer
LIBERATE Study: Guardant Reveal showed high sensitivity and 100% positive predictive value for relapse PALO ALTO, Calif., June 09, 2025--(BUSINESS WIRE)--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 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. View source version on Contacts Investor Contact: Zarak Khurshidinvestors@ Media Contact: Michael Weistpress@ +1 317-371-0035
Business Wire
09-06-2025
- Business
- Business Wire
New Study Published in ESMO Open Highlights Guardant Reveal's Performance in Detecting Minimal Residual Disease in Patients with Early-Stage Breast Cancer
PALO ALTO, Calif.--(BUSINESS WIRE)--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 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.
Business Insider
02-06-2025
- Health
- Business Insider
Guardant Health presented results of largest study on ctDNA in colon cancer
Guardant Health (GH) presented results of the largest study to date evaluating circulating tumor DNA, ctDNA, in colon cancer prior to chemotherapy, demonstrating the ability of the Guardant Reveal test to stratify the risk of disease recurrence and overall survival, and thus inform treatment decisions after surgery. Data from the phase III trial of FOLFOX-based adjuvant chemotherapy involving over 2,000 patients with stage III colon cancer with median follow-up of 6.1 years were presented at the 2025 American Society for Clinical Oncology Annual Meeting. Results demonstrated that circulating tumor DNA detected in the bloodstream after cancer surgery and prior to the start of adjuvant therapy, using the Guardant Reveal test, is a strong predictor of the risk of disease recurrence and poorer survival, and suggest the potential for ctDNA testing to improve decision-making at a critical time point for post-operative chemotherapy. Specifically: Among patients with post-surgical ctDNA detected, 62.6% had the cancer return within 3 years, despite having had adjuvant chemotherapy, while only 15.4% of patients with undetectable ctDNA recurred in the same period. The level of ctDNA, or tumor fraction, showed promise in identifying individuals who are less likely to clear residual disease with adjuvant treatment.
Business Wire
31-05-2025
- Health
- Business Wire
In Largest Molecular Residual Disease (MRD) Study in Colon Cancer, Guardant Reveal Testing Prior to Chemotherapy Provides Robust Stratification for Risk of Disease Recurrence and Survival to Enable Timely Treatment Decisions
PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, and its research collaborators today presented results of the largest study to date evaluating circulating tumor DNA (ctDNA) in colon cancer prior to chemotherapy, demonstrating the ability of the Guardant Reveal™ test to stratify the risk of disease recurrence and overall survival, and thus inform treatment decisions after surgery. Data from the phase III trial of FOLFOX-based adjuvant chemotherapy (NCCTG N0147) involving over 2,000 patients with stage III colon cancer with median follow-up of 6.1 years were presented at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting. Results demonstrated that circulating tumor DNA detected in the bloodstream after cancer surgery and prior to the start of adjuvant therapy, using the Guardant Reveal test, is a strong predictor of the risk of disease recurrence and poorer survival, and suggest the potential for ctDNA testing to improve decision-making at a critical time point for post-operative chemotherapy. Specifically: Among patients with post-surgical ctDNA detected, 62.6% had the cancer return within 3 years, despite having had adjuvant chemotherapy, while only 15.4% of patients with undetectable ctDNA recurred in the same period. The level of ctDNA, or tumor fraction, showed promise in identifying individuals who are less likely to clear residual disease with adjuvant treatment. 'Thirty percent of patients with stage III colon cancer will relapse after surgery, despite having standard adjuvant chemotherapy,' said Frank Sinicrope, MD, professor of oncology and medicine at Mayo Clinic and principal investigator for the study. 'In this study, we demonstrate that analysis of postsurgical ctDNA can improve the prediction of disease recurrence over standard staging criteria, which may help guide patient management and follow-up. These data further support the routine use of ctDNA in management of stage III colon cancer patients.' 'With the Guardant Reveal test, a simple blood draw can be used to identify colorectal cancer patients who have molecular residual disease and are most likely to benefit from adjuvant therapy,' said Helmy Eltoukhy, Guardant Health chairman and co-CEO. 'This large study confirms the test's ability to identify high risk of cancer returning and support oncologists in making more informed therapeutic decisions to help improve patient outcomes.' The full abstract for the presentation can be found on the ASCO website. About Guardant Reveal Guardant Reveal, which runs on the Guardant Infinity™ smart liquid biopsy platform, is a blood test that uses epigenomic (methylation) analysis to detect circulating tumor DNA, a marker of minimal residual disease, to predict cancer recurrence, helping to guide clinical decisions after surgery or chemotherapy. The test is covered by Medicare for patients with colorectal cancer in the early post-surgical setting and for surveillance testing to monitor for disease recurrence after curative intent treatment. About Molecular Residual Disease Molecular residual disease refers to a subclinical measure of cancer burden that remains during and following treatment. A patient's MRD status is a reliable indicator of clinical outcome and response to therapy and can be used for risk stratification and to guide treatment options when used in conjunction with other clinical data. 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 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.
