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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
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

Business Wire

time3 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.

M42 and Hikma sign strategic MOU to enhance preventive and predictive cancer care in the UAE - Middle East Business News and Information
M42 and Hikma sign strategic MOU to enhance preventive and predictive cancer care in the UAE - Middle East Business News and Information

Mid East Info

time31-01-2025

  • Business
  • Mid East Info

M42 and Hikma sign strategic MOU to enhance preventive and predictive cancer care in the UAE - Middle East Business News and Information

M42, a global health leader powered by artificial intelligence (AI), and Hikma Pharmaceuticals PLC (Hikma), announced the signing of a strategic memorandum of understanding (MOU), to accelerate the implementation of more precise, preventive and predictive cancer care programmes, utilising cutting-edge genomics screening technology. Under this agreement, Hikma and M42 will enhance their collaboration to promote the use of Shield™, a non-invasive laboratory-developed test (LDT) by Guardant Health Inc., for colorectal cancer (CRC) screening, aiming to improve screening adherence rates in the UAE. Shield™ is the first blood test to be approved by the US FDA as a primary screening option for CRC, meaning healthcare providers can offer Shield in a manner similar to all other non-invasive methods recommended in screening guidelines. Dr. Fahed Al Marzooqi, Chief Executive Officer, Integrated Health Solutions, M42, said: 'At M42, we are committed to harnessing cutting-edge technologies to improve patient outcomes and empower health systems to deliver proactive care. This collaboration with Hikma reflects our dedication to supporting Abu Dhabi's broader efforts to lead in next-generation screening and health innovation. By integrating AI and genomics-driven solutions, we are redefining traditional healthcare models to create a healthier, more sustainable future for all.' Mazen Darwazah, Hikma's Executive Vice Chairman and President of MENA, said: ' We are proud to sign this strategic partnership with M42 – a company that shares our commitment to innovation shaping the future of healthcare to improve patient outcomes. This important endeavour is focused on enhancing early disease detection, enabling more precise diagnoses, and facilitating more effective treatments, particularly in oncology and preventive care, which is aligned with our ambition of providing broader healthcare solutions focused on precision medicine.' Last year Hikma announced that it had signed an exclusive agreement with Guardant Health, Inc. for the commercialisation and marketing of Guardant Health's portfolio of liquid and tissue biopsy tests for cancer screening, recurrence monitoring and tumour mutation profiling across all solid cancers in the Middle East and North Africa (MENA). The agreement includes tests such as the US FDA approved Shield™ for colorectal cancer screening and early detection, as well as Guardant Reveal™ for minimal residual disease detection and recurrence monitoring and Guardant360® and Guardant360 TissueNext™ for comprehensive genomic profiling across all solid cancers. The introduction of the Shield™ test for colorectal cancer screening marks a transformative step in advancing precision and preventive healthcare across the region.

Guardant Health to Present Data at ASCO GI Demonstrating the Value of Its Precision Oncology Tools for Cancer Detection, Treatment Decisions and Therapy Development
Guardant Health to Present Data at ASCO GI Demonstrating the Value of Its Precision Oncology Tools for Cancer Detection, Treatment Decisions and Therapy Development

Yahoo

time27-01-2025

  • Business
  • Yahoo

Guardant Health to Present Data at ASCO GI Demonstrating the Value of Its Precision Oncology Tools for Cancer Detection, Treatment Decisions and Therapy Development

Data shared from phase II NEO trial highlights Guardant Reveal™ as a decision tool to support organ preservation in rectal cancer PALO ALTO, Calif., January 23, 2025--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company and its research collaborators will present data showcasing the benefits of Guardant's precision oncology tools across cancer screening, recurrence monitoring, treatment selection and therapy development at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, January 23-25, 2025. Key focus areas in Guardant's co-authored abstracts and collaborator presentations utilizing Guardant products include the impact of mutations on treatment response in colorectal cancer and biliary tract cancers, and additional support for the benefits of blood-based screening in colorectal, gastric and esophageal cancers. A rapid oral presentation will feature data from the phase II NEO trial highlighting Guardant Reveal as a decision tool to support organ preservation in patients with node-negative rectal cancer undergoing neoadjuvant chemotherapy, excision and observation. "Data increasingly supports the value of precision oncology tools, and specifically liquid biopsy, in detecting GI cancers, informing treatment selection, and monitoring for recurrence and therapy response," said Craig Eagle, MD, Guardant Health chief medical officer. "Findings presented at ASCO GI demonstrate the advancements being made by Guardant Health and our partners in these areas and show the potential for these tools to provide even more personalized cancer care, leading to better patient outcomes." Guardant Health ASCO GI 2025 Co-Authored Posters and Presentations Time and Location Title Abstract and Presentation Type Guardant Reveal January 25, 2025 9:15 – 10:00 am PST Level 2, Ballroom Tumour-free ctDNA detection as a decision tool to support organ preservation in node-negative rectal cancer undergoing neoadjuvant chemotherapy, excision, and observation in the phase II NEO trial (CCTG CO.28) Rapid Oral Abstract Session C Abstract #20 Guardant360® January 25, 2025 7:00 – 7:55 am PST Level 1, West Hall Retrospective study evaluating the genomic landscape of anal squamous cell carcinoma using liquid biopsy Poster Session C Abstract #8 Landscape of metastatic colorectal cancer (CRC) using comprehensive circulating tumor DNA (ctDNA) next-generation sequencing (NGS) in India: Expanding beyond RAS and RAF Poster Session C Abstract #49 GuardantINFORM™ January 24, 2025 11:30 am – 1:00 pm PST Level 1, West Hall Real-world survival differences in advanced biliary tract cancer patients with ctDNA detected IDH1 mutations and FGFR2 fusions receiving first-line gemcitabine-cisplatin with and without immunotherapy Poster Session B Abstract #548 ShieldTM January 25, 2025 7:00 – 7:55 am PST Level 1, West Hall Cost-effectiveness of blood-based colorectal cancer screening: A simulation model incorporating real-world longitudinal adherence Poster Session C Abstract #93 A method for classifying colorectal cancer and gastric/esophageal cancer using blood-based testing Poster Session C Abstract #52 The full abstracts for Guardant Health and a list of all abstracts being presented at ASCO GI 2025 can be found on the ASCO website. For information and updates from the conference, follow Guardant Health on LinkedIn, X (Twitter) and Facebook. 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, 2023, 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 Sign in to access your portfolio

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