Latest news with #VanguardStudy
NZ Herald
a day ago
- Health
- NZ Herald
Blood tests show promise in early cancer detection, and further large-scale studies are planned
But a study recruiting subjects this northern summer, funded by the National Cancer Institute, seeks to begin to do that by answering basic questions about how the tests perform in comparison to more conventional cancer screening. What will the study consider? A screening test given to millions of healthy people has to be accurate to avoid costly and anxiety-inducing follow-ups. And for it to become part of routine medical care, there needs to be evidence that the test can reliably find cancers – perhaps far earlier than routine methods. Most importantly, scientists want to see clear evidence that earlier detection leads to longer lives. To begin to fill this knowledge gap, scientists at nine sites around the United States are recruiting up to 24,000 people between the ages of 45 and 75 for the Vanguard Study. Participants will be randomly assigned to receive either regular screening or one of two multi-cancer detection tests. All of the groups will be told to continue with regular cancer screenings and will be followed over two years. The blood tests used in the study will screen for a variety of cancers, including many for which there aren't more traditional screening tests: bladder, breast, colorectal, oesophageal, stomach, liver, lung, ovarian, pancreatic, and prostate. Researchers, guided by what they learn from this first trial, hope to launch a much larger trial, with about 150,000 people, to definitively establish the effectiveness of these tests in preventing deaths. Bert Vogelstein has been working on these ideas for 30 years at Johns Hopkins Medicine and is a scientific founder of Exact Sciences, a company working to make blood tests for cancer screenings but is not involved in the new trial. He said the field is still in its adolescence. 'But adolescents can do a lot of great things, that's clear in athletics and it's clear in science,' Vogelstein said. 'I think what NCI is doing is great. And I applaud those efforts, because tests can do good or harm.' What are the benefits and harms? The benefit of early cancer detection is intuitive. People could roll up their sleeves and get a blood test to flag 20 cancers, allowing physicians to give early treatments when they have no symptoms. That could dramatically reduce the need for people to go through years of illness and advanced cancer treatments. 'That dream, to me, is decades off, but we're starting on it now – which is why it's so exciting,' said Scott Ramsey, a physician and researcher at the Fred Hutchinson Cancer Centre and a principal investigator with the Cancer Screening Research Network, which will be running the Vanguard study. 'We're not talking about treating people who are sick; we're talking about preventing people of dying [from] cancer in the first place.' The harms of screening are not always as clear to the public, but they show the trade-offs inherent when providing a medical intervention to healthy people. Ramsey pointed to the history around prostate specific antigen (PSA) tests, which identified many prostate cancers early – some of which would have never shown symptoms or caused death. That meant that many men were aggressively treated, with surgery and radiation that caused them to be incontinent or impotent for years or decades. The recommendations on how to test for prostate cancer changed as these trends became clear over decades. Ramsey said that now is the right moment to be subjecting these cancer blood tests to scrutiny. The potential for the tests is enormous, but there are fundamental questions that need to be answered about how and when they should be used – and, perhaps, when they shouldn't. What needs to happen next? The recent study in Cancer Discovery illustrated one of the major problems facing the field. To detect cancers early, the tests need a big boost in sensitivity, because they need to find fragments of cancer tumour DNA that are scarce. That study found that it was possible to detect cancer three or more years earlier than a traditional diagnosis. 'It can be done – and that's an important part of the article, much earlier than had ever been shown before,' said Vogelstein, part of the team behind the study. But to detect those trace amounts of genetic material, the sensitivity of the test had to be roughly 50 times higher than what it is in tests today, he said – and would likely cost a few thousand dollars. Ramsey said current US tests can be US$900 ($1511) or more. Health insurance carriers typically won't pay for them yet, because it isn't clear what their benefits and harms are. 'The bottom line is we don't know whether when taking one of these tests will give you an opportunity to live longer without cancer – or longer overall,' Ramsey said. 'There's never been a study that established that.'
Business Wire
2 days ago
- Business
- Business Wire
First Patient Enrolled in National Cancer Institute's Vanguard Study Evaluating Guardant Health's Shield Multi-Cancer Detection Test
PALO ALTO, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that patient enrollment has begun in the National Cancer Institute (NCI)'s Vanguard Study to evaluate emerging multi-cancer detection (MCD) technology. Guardant's Shield™ MCD test was selected for use in the four-year study, which aims to enroll up to 24,000 patients and evaluate the use of MCD tests—blood tests that can screen for several types of cancer simultaneously—in future randomized controlled trials. Guardant's Shield MCD test was chosen for the study based on the overall performance of its Shield platform in detecting 10 cancer types, including lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver and gastric. The data were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. The Vanguard study was initiated following review and approval by the U.S. Food and Drug Administration (FDA) as part of the NCI's submission for an investigational device exemption (IDE). 'New screening technology like the Shield MCD test has the potential to detect multiple cancers earlier through a simple blood draw,' said Craig Eagle, MD, Guardant Health Global Chief Medical Officer. 'The earlier we can screen and diagnose cancers, the more options we can bring to patients and ultimately the more lives we can save. The Vanguard Study is a critical step in research to evaluate the role of this breakthrough technology in helping reduce cancer deaths.' The Vanguard Study, conducted by the Cancer Screening Research, a new NCI-sponsored clinical trials network, is enrolling individuals ages 45-75 who do not currently have cancer and who have not received a cancer diagnosis in the past five years. All participants will be offered standard cancer screenings as part of their care. Results from the study will inform the design of a much larger randomized controlled trial to evaluate the use of MCD tests for cancer screening. 'Initiation of the Vanguard Study is an exciting milestone, as we look to evaluate a new way to screen for cancer,' said Scott Ramsey, M.D., Ph.D., director of the Hutchinson Institute for Cancer Outcomes Research at Fred Hutch Cancer Center and principal investigator for the Vanguard Study. 'The study will help us learn more about multi-cancer detection tests and assess whether they can help people from all backgrounds find cancer early, when it may be easier to treat.' The Shield MCD test recently received Breakthrough Device Designation from the FDA 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 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. For more information, please visit the Fred Hutch Cancer Center Vanguard Study 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.
Yahoo
04-06-2025
- 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
03-06-2025
- 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
03-06-2025
- 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
