Latest news with #GuardantHealth
Business Wire
3 hours ago
- Business
- Business Wire
FDA Grants Breakthrough Device Designation to Guardant Health's Shield Multi-Cancer Detection (MCD) Test
PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer. The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide for more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA's Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review. 'Every late-stage cancer we avert is a win for patients and for the entire healthcare system,' said AmirAli Talasaz, Guardant Health co-founder and co-CEO. 'This recognition by the FDA shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw. We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly.' The Breakthrough Device designation by the FDA of the Shield MCD test builds on its recent selection by the National Cancer Institute (NCI) for the Vanguard Study evaluating emerging MCD technology. The Shield MCD test was chosen for the Vanguard study based on its strong performance in predicting the presence of cancers and cancer tissue of origin. At the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Guardant presented data on the clinical validation of the Shield MCD test showing that the blood-based test exhibits high specificity, clinically meaningful sensitivity and strong cancer signal of origin accuracy across multiple tumor types. The data presented from a case-control cohort showed that the Shield MCD test has 98.6% specificity and 75% cancer sensitivity across bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancers (per-cancer sensitivity range: 62-96%). Primary or secondary CSO (cancer signal origin) accuracy was 92%. 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
3 hours ago
- Business
- Yahoo
FDA Grants Breakthrough Device Designation to Guardant Health's Shield Multi-Cancer Detection (MCD) Test
PALO ALTO, Calif., June 03, 2025--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer. The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide for more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA's Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review. "Every late-stage cancer we avert is a win for patients and for the entire healthcare system," said AmirAli Talasaz, Guardant Health co-founder and co-CEO. "This recognition by the FDA shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw. We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly." The Breakthrough Device designation by the FDA of the Shield MCD test builds on its recent selection by the National Cancer Institute (NCI) for the Vanguard Study evaluating emerging MCD technology. The Shield MCD test was chosen for the Vanguard study based on its strong performance in predicting the presence of cancers and cancer tissue of origin. At the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Guardant presented data on the clinical validation of the Shield MCD test showing that the blood-based test exhibits high specificity, clinically meaningful sensitivity and strong cancer signal of origin accuracy across multiple tumor types. The data presented from a case-control cohort showed that the Shield MCD test has 98.6% specificity and 75% cancer sensitivity across bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancers (per-cancer sensitivity range: 62-96%). Primary or secondary CSO (cancer signal origin) accuracy was 92%. 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: Meaghan Smithpress@ Sign in to access your portfolio
Associated Press
3 hours ago
- Business
- Associated Press
FDA Grants Breakthrough Device Designation to Guardant Health's Shield Multi-Cancer Detection (MCD) Test
PALO ALTO, Calif.--(BUSINESS WIRE)--Jun 3, 2025-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer. The FDA grants Breakthrough Device designation to a limited set of qualifying devices that have the potential to provide for more effective treatment or diagnosis of life-threatening diseases, such as cancer, than current options. The goal of the FDA's Breakthrough Devices Program is to provide patients and healthcare providers with timely access to medical devices by speeding up their development, assessment and review. 'Every late-stage cancer we avert is a win for patients and for the entire healthcare system,' said AmirAli Talasaz, Guardant Health co-founder and co-CEO. 'This recognition by the FDA shows the promise of the Shield MCD test to detect multiple cancers at an early stage with just a single, routine blood draw. We look forward to partnering with the agency and other stakeholders to bring this breakthrough to patients quickly.' The Breakthrough Device designation by the FDA of the Shield MCD test builds on its recent selection by the National Cancer Institute (NCI) for the Vanguard Study evaluating emerging MCD technology. The Shield MCD test was chosen for the Vanguard study based on its strong performance in predicting the presence of cancers and cancer tissue of origin. At the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago, Guardant presented data on the clinical validation of the Shield MCD test showing that the blood-based test exhibits high specificity, clinically meaningful sensitivity and strong cancer signal of origin accuracy across multiple tumor types. The data presented from a case-control cohort showed that the Shield MCD test has 98.6% specificity and 75% cancer sensitivity across bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancers (per-cancer sensitivity range: 62-96%). Primary or secondary CSO (cancer signal origin) accuracy was 92%. 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 CONTACT: Investor Contact: Zarak Khurshid [email protected] Contact: Meaghan Smith [email protected] KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA INDUSTRY KEYWORD: FDA HEALTH ONCOLOGY MEDICAL DEVICES SOURCE: Guardant Health, Inc. Copyright Business Wire 2025. PUB: 06/03/2025 08:05 AM/DISC: 06/03/2025 08:03 AM
Business Insider
8 hours ago
- Business
- Business Insider
Cathie Wood's ARK Investment buys 158.7K shares of Guardant Health today
21:01 EDT Cathie Wood's ARK Investment buys 158.7K shares of Guardant Health (GH) today Confident Investing Starts Here: Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Associated Press
a day ago
- Business
- Associated Press
National Comprehensive Cancer Network (NCCN) Updates Colorectal Cancer Screening Guidelines to Include Shield Blood-Based Screening
PALO ALTO, Calif.--(BUSINESS WIRE)--Jun 2, 2025-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the National Comprehensive Cancer Network (NCCN) has included the Shield blood test in its updated colorectal cancer (CRC) screening guidelines. The Shield test detects CRC signals in the bloodstream from DNA that is shed by tumors, called circulating tumor DNA (ctDNA). The updated NCCN CRC Screening Guidelines reflect the addition of Shield with a recommendation for testing every three years. 'With a simple blood draw, Shield provides a more convenient and pleasant screening option for the millions of eligible Americans who are forgoing their recommended screening for colorectal cancer,' said AmirAli Talasaz, Guardant Health co-CEO. 'This major guideline inclusion from the National Comprehensive Cancer Network is just the first for Shield, and we believe a pivotal step for more patients to benefit from this test.' In its guideline update, the NCCN pointed to Guardant's landmark ECLIPSE (Evaluation of ctDNA LUNAR Assay in an Average Patient Screening Episode) study evaluating the performance of Shield compared to a screening colonoscopy. One of the largest studies of its kind and published in the New England Journal of Medicine (NEJM), ECLIPSE demonstrated that the Shield blood test is highly effective in detecting CRC, with a sensitivity of 83 percent. About Shield Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation. 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 CONTACT: Investor Contact: Zarak Khurshid [email protected] Contact: Meaghan Smith [email protected] KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA INDUSTRY KEYWORD: BIOTECHNOLOGY HEALTH ONCOLOGY OTHER HEALTH SOURCE: Guardant Health, Inc. Copyright Business Wire 2025. PUB: 06/02/2025 08:05 AM/DISC: 06/02/2025 08:03 AM
