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Yahoo
2 days ago
- Business
- Yahoo
Guardant Health's MCD test earns FDA breakthrough designation
Guardant Health's Shield multi-cancer detection (MCD) test has secured the US Food and Drug Administration's (FDA) breakthrough device designation. This methylation-based blood test is designed for the screening of various types of cancer in people who are 45 or above and are at a typical average cancer risk. The tested cancers include colorectal, oesophageal, bladder, gastric, lung, liver, pancreas, and ovarian. The FDA's designation for the MCD test follows its selection by the National Cancer Institute (NCI) for the Vanguard Study assessing the technology. This test was selected based on its predictive performance for cancer presence and for identifying the origin of the cancer tissue. At the 2025 American Society for Clinical Oncology Annual Meeting in Illinois, US, Guardant Health presented data from a case-control cohort of the Shield MCD test. The findings demonstrated the test's specificity and sensitivity, along with accuracy in determining the cancer signal of origin across various types of tumours. It exhibits 98.6% specificity and 75% sensitivity for detecting cancers, as per the data. The sensitivity range for individual cancers varied between 62% and 96%, with primary or secondary cancer signal origin accuracy reaching 92%. The breakthrough device designation is awarded to a select group of medical devices that show potential in treating or diagnosing life-threatening conditions compared to existing options. Guardant Health co-CEO and co-founder AmirAli Talasaz said: 'Every late-stage cancer we avert is a win for patients and for the entire healthcare system. '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.' Last year, the company expanded its market reach by striking a deal to promote its range of liquid and tissue biopsy tests for cancer screening in the Middle East and North Africa region. "Guardant Health's MCD test earns FDA breakthrough designation" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
3 days 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 days 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
