Latest news with #HelmyEltoukhy
Business Wire
a day ago
- Business
- Business Wire
SERENA-6 Phase III Trial Demonstrates Clinical Value of Guardant360 CDx Test to Detect Emergence of Endocrine Resistance and Inform a Switch in Therapy Before Radiological Disease Progression in Advanced Breast Cancer
PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the results of the Phase III SERENA-6 trial - sponsored by AstraZeneca - demonstrate the clinical value of the Guardant360® CDx test in a circulating tumor DNA-guided approach to detect and treat emerging resistance in 1st-line therapy ahead of radiological disease progression in breast cancer. Study results were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago and were published in The New England Journal of Medicine. SERENA-6 is the first global, double-blind, registrational Phase III trial to use a ctDNA-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression is detected in imaging scans. The novel trial design used ctDNA monitoring with the Guardant360 liquid biopsy test at the time of routine tumor scans to identify patients for early signs of endocrine resistance and the emergence of ESR1 mutations. 'SERENA-6 is a landmark study that is creating a new paradigm using liquid biopsy to enable a switch to a new treatment as soon as you see the cancer showing signs of resistance,' said Helmy Eltoukhy, Guardant Health chairman and co-CEO. 'This use of the Guardant360 CDx test 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 and improve outcomes in patients with advanced breast cancer.' Following detection of an ESR1 mutation without radiological disease progression, the endocrine therapy of patients was switched to AstraZeneca's camizestrant from ongoing treatment with an aromatase inhibitor (AI), while continuing combination with the same cyclin-dependent kinase (CDK) 4/6 inhibitor. The trial demonstrated a highly statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors had an emergent ESR1 mutation as detected by Guardant360 CDx. About Guardant360 CDx The first FDA-approved blood test for complete genomic testing, Guardant360 CDx is approved as a companion diagnostic fur multiple therapies in non-small cell lung cancer. It is also the only FDA-approved companion diagnostic for targeted therapy in advanced breast cancer patients with ESR1 mutations. The test is broadly covered by Medicare and commercial insurers, representing over 300 million lives. For more information, visit the Guardant360 CDx website. 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 Wire
3 days ago
- 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.
Yahoo
5 days ago
- Health
- Yahoo
Guardant Health, Inc. (GH) Expands Liquid Biopsy to Pinpoint Tumor Origins and Biomarkers
Guardant Health, Inc. (NASDAQ:GH) has introduced major upgrades to its Guardant360 Liquid biopsy test, significantly expanding its cancer biomarker detection and subtyping abilities. Utilizing the Guardant Infinity platform and AI-driven analysis, the test now offers comprehensive multiomic profiling from a simple blood draw. A patient viewing their medical diagnosis on a digital healthcare ecosystem. The enhanced test helps doctors quickly exclude actionable mutations in lung and colorectal cancers, identify cancer origins when unknown, and accurately classify breast and lung cancer subtypes through tumor methylation patterns. It also integrates pharmacogenomic data to guide safe drug use, detects viruses like HPV and EBV affecting treatment, assesses Homologous Recombination Deficiency (HRD) for targeted therapies, and uses HLA genotyping to inform therapy choices and clinical trial options. Guardant Health, Inc. (NASDAQ:GH)'s co-CEO Helmy Eltoukhy highlighted that this blood-based test provides vital tumor insights without needing tissue samples, delivering results within seven days and enabling faster, smarter cancer treatment decisions. While we acknowledge the potential of GH to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than GH and that has 100x upside potential, check out our report about this READ NEXT: and Disclosure: None.
Yahoo
7 days ago
- Business
- Yahoo
Guardant Health Introduces Nearly a Dozen Groundbreaking Smart Liquid Biopsy Applications for Guardant360 Liquid Test
For the first time, fundamental tumor phenotypes determined by a simple blood test Single test now provides molecular tumor typing, subtyping and confirmation of absence of actionable biomarkers to give clinicians critical insights to guide optimal treatment PALO ALTO, Calif., May 27, 2025--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced major new features for the Guardant 360® Liquid test that greatly expand its biomarker identification and cancer subtyping capabilities to help oncologists identify optimal treatment plans. The expanded applications are enabled through the multiomic profiling capabilities of the Guardant Infinity™ smart liquid biopsy platform and its AI learning engine, which analyzes large sets of patient data to identify patterns and refine predictions. Some of the groundbreaking new applications for the Guardant360 Liquid test will allow healthcare providers to do the following in order to improve patient outcomes: Confirm no actionable mutations in lung and colorectal cancers—helping fast-track patients to treatment without extra testing. Identify the origin of cancers when the primary site is unknown, guiding better diagnosis and therapy. Classify breast ER/PR/HER2 status and lung cancer histology subtypes with high precision by interpreting tumor-specific methylation signatures, enhancing standard testing methods. Use pharmacogenomics to identify genetic variations vital for safe and effective use of common anti-cancer therapies, including those with FDA black box labeling. Detect human papillomavirus (HPV) and Epstein-Barr (EBV), which influence prognosis and treatment plans in certain cancers. Determine Homologous Recombination Deficiency (HRD) status to inform use of specific therapies like PARP inhibitors and platinum-based chemotherapy. Use Human Leukocyte Antigen (HLA) genotyping as a biomarker to inform therapy selection and identify clinical trial opportunities. "For the first time ever, we're able to reveal vital details about a tumor – including its fundamental phenotype and biological behavior – from just a blood sample," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "This gives healthcare providers the insights they need about a patient's cancer to make smarter treatment decisions, even when they can't access tumor tissue for analysis. The novel blood-based approach to comprehensive molecular profiling using our Guardant Infinity Smart Liquid Biopsy platform offers immense potential for future applications in cancer and beyond." Comprehensive biomarker testing through immunohistochemistry using tumor tissue has been the standard of care in oncology and helps ensure that clinicians don't miss critical information about a patient's specific type of cancer. The Guardant360 Liquid test now provides access to this extensive molecular profiling information through the blood by looking at the unique methylation signatures of specific tumor biomarkers. Guardant liquid biopsy tests have been clinically validated in more than 1,000 publications and research abstracts. Test results for Guardant360 Liquid are available within seven days. For more information, visit the Guardant Health website. 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
Yahoo
7 days ago
- Business
- Yahoo
Guardant Health Introduces Nearly a Dozen Groundbreaking Smart Liquid Biopsy Applications for Guardant360 Liquid Test
For the first time, fundamental tumor phenotypes determined by a simple blood test Single test now provides molecular tumor typing, subtyping and confirmation of absence of actionable biomarkers to give clinicians critical insights to guide optimal treatment PALO ALTO, Calif., May 27, 2025--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced major new features for the Guardant 360® Liquid test that greatly expand its biomarker identification and cancer subtyping capabilities to help oncologists identify optimal treatment plans. The expanded applications are enabled through the multiomic profiling capabilities of the Guardant Infinity™ smart liquid biopsy platform and its AI learning engine, which analyzes large sets of patient data to identify patterns and refine predictions. Some of the groundbreaking new applications for the Guardant360 Liquid test will allow healthcare providers to do the following in order to improve patient outcomes: Confirm no actionable mutations in lung and colorectal cancers—helping fast-track patients to treatment without extra testing. Identify the origin of cancers when the primary site is unknown, guiding better diagnosis and therapy. Classify breast ER/PR/HER2 status and lung cancer histology subtypes with high precision by interpreting tumor-specific methylation signatures, enhancing standard testing methods. Use pharmacogenomics to identify genetic variations vital for safe and effective use of common anti-cancer therapies, including those with FDA black box labeling. Detect human papillomavirus (HPV) and Epstein-Barr (EBV), which influence prognosis and treatment plans in certain cancers. Determine Homologous Recombination Deficiency (HRD) status to inform use of specific therapies like PARP inhibitors and platinum-based chemotherapy. Use Human Leukocyte Antigen (HLA) genotyping as a biomarker to inform therapy selection and identify clinical trial opportunities. "For the first time ever, we're able to reveal vital details about a tumor – including its fundamental phenotype and biological behavior – from just a blood sample," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "This gives healthcare providers the insights they need about a patient's cancer to make smarter treatment decisions, even when they can't access tumor tissue for analysis. The novel blood-based approach to comprehensive molecular profiling using our Guardant Infinity Smart Liquid Biopsy platform offers immense potential for future applications in cancer and beyond." Comprehensive biomarker testing through immunohistochemistry using tumor tissue has been the standard of care in oncology and helps ensure that clinicians don't miss critical information about a patient's specific type of cancer. The Guardant360 Liquid test now provides access to this extensive molecular profiling information through the blood by looking at the unique methylation signatures of specific tumor biomarkers. Guardant liquid biopsy tests have been clinically validated in more than 1,000 publications and research abstracts. Test results for Guardant360 Liquid are available within seven days. For more information, visit the Guardant Health website. 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 Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
