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TEST:
GUARDANT SHIELD

Type:
Laboratory Developed Test
Related tests:
Evidence

News

15d
Guardant Health ECLIPSE Study Data Demonstrating Efficacy of Shield Blood-based Test for Colorectal Cancer Screening to be Published in The New England Journal of Medicine (Businesswire)
P=Obs | N=40,000 | ECLIPSE (NCT04136002) | Sponsor: Guardant Health, Inc. | "Guardant Health...announced that results from the ECLIPSE study showing the effectiveness of its Shield blood test for detecting colorectal cancer (CRC) in average-risk adults will be published in the March 14 issue of The New England Journal of Medicine....Highlights of the study results to be published in The New England Journal of Medicine show that Shield demonstrated: 83% sensitivity in detecting individuals with CRC; 88% sensitivity in detecting pathology-confirmed Stages I-III; Sensitivity by stage of: 65% for pathology-confirmed Stage I; 55% for clinical Stage I; 100% for Stage II; 100% for Stage III; 100% for Stage IV. These results are on par with the performance of other guideline-recommended non-invasive screening modalities, where overall sensitivity in detecting colorectal cancer ranges from 74% to 92%."
Observational data
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GUARDANT SHIELD
2ms
Guardant Health to present data at ASCO GI supporting use of liquid biopsy to predict colon cancer recurrence (Businesswire)
"Guardant Health, Inc...will present interim data from the COSMOS study supporting the use of Guardant Reveal to predict disease recurrence in patients with early-stage colon cancer at the ASCO 2024 Gastrointestinal Cancers Symposium, January 18-20 in San Francisco....Interim data to be shared at ASCO GI suggest the test is both highly specific (low false positives) and predictive for recurrence, without dependence on a tissue sample....Guardant and its research partners will also present multiple posters at the symposium highlighting the application of Guardant technology in blood-based screening and in identifying potentially targetable mutations in GI cancers, including predictive markers for treatment resistance."
P2/3 data
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Guardant360® CDx • GUARDANT SHIELD • GuardantREVEAL
3ms
Guardant Health and Hikma partner to offer cancer screening and comprehensive genomic profiling tests in the Middle East and North Africa (Guardant Health Press Release)
"Guardant Health, Inc...and Hikma Pharmaceuticals PLC...announced an agreement to promote Guardant Health’s portfolio of liquid and tissue biopsy tests for cancer screening, recurrence monitoring and tumor mutation profiling across all solid cancers in countries across the Middle East and North Africa (MENA)...The tests offered include Shield™ for cancer screening and early detection, Guardant Reveal™ for minimal residual disease detection and recurrence monitoring, and Guardant360® and Guardant360 TissueNext™ for comprehensive genomic profiling across all solid cancers."
Licensing / partnership
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Guardant360® CDx • Guardant360 TissueNext™ • GUARDANT SHIELD • GuardantREVEAL
3ms
Guardant Health announces tentative date of FDA Advisory Panel review of Shield™ blood test (Guardant Health Press Release)
"Guardant Health, Inc...announced that the U.S. Food and Drug Administration’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application (PMA) for the company’s Shield™ blood test to screen for colorectal cancer on March 28, 2024. The date and details of the meeting are subject to confirmation by the FDA and publication in the Federal Register."
FDA event
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GUARDANT SHIELD
5ms
Guardant Health launches Shield blood-based screening test for colorectal cancer in South Korea (PRNewswire)
"Guardant Health, Inc...announced that it has launched its blood-based colorectal cancer screening test, Shield, in collaboration with Samsung Medical Center in South Korea. Colorectal cancer (CRC) is one of the most commonly diagnosed cancers and the third-leading cause of cancer-related deaths in South Korea. Guardant Health's Shield test, which can be used for regular CRC screening in eligible individuals, is an innovative test that can detect cancer in its early stages by analysing circulating tumour DNA (ctDNA), which is produced when tumours shed small pieces of their genetic material into the bloodstream. In the pivotal ECLIPSE study, which enrolled over 20,000 patients, the Shield test achieved 83% sensitivity for the detection of colorectal cancer in average-risk adults in the U.S., with specificity of 90%."
Launch non-US
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GUARDANT SHIELD
7ms
Enrollment open
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GUARDANT SHIELD
8ms
Study of Colorectal Cancer Screening Options (clinicaltrials.gov)
P=N/A; N=400; Completed; Sponsor:Kaiser Permanente
New trial
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GUARDANT SHIELD
10ms
Guardant Health to present 17 scientific abstracts highlighting contribution of its blood tests and real-world data to advances in precision oncology and cancer screening at 2023 ASCO annual meeting (Businesswire)
"Guardant Health, Inc...announced today that the company and its research collaborators will present data from 17 studies that highlight the contribution of Guardant blood tests and real-world data to advances in precision oncology and cancer screening at the 2023 American Society for Clinical Oncology (ASCO) Annual Meeting, June 2-6 in Chicago....Guardant Health will present a session highlighting the performance of the Guardant Infinity platform in the detection of homologous recombination deficiency (HRD) status in patients with breast cancer....Guardant Health collaborators will present a session on the ESR1 mutational landscape and the impact of co-existing resistance variants on clinical outcomes in patients with metastatic breast cancer."
Clinical data
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Guardant360® CDx • GUARDANT SHIELD • GuardantINFINITY™
11ms
Guardant Health presents additional information from ECLIPSE study at 2023 Digestive Disease Week on the performance of Shield™ blood test (Guardant Health Press Release)
"Guardant Health, Inc...presented additional data from the ECLIPSE study at 2023 Digestive Disease Week (DDW) titled, 'Clinical Validation of a Cell-Free DNA Blood-Based Test for Colorectal Cancer in an Average Risk Population' (Abstract #913e) showcasing the performance of its blood-based technology to accurately detect early-stage colorectal cancer (CRC)...Shield™ blood test achieved overall 83% sensitivity and 90% specificity and demonstrated early-stage detection in range with other guideline-recommended non-invasive CRC screening modalities"
Clinical data
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GUARDANT SHIELD
11ms
The Ohio State University Guardant Shield Colorectal Cancer Screening Project. (ASCO 2023)
Enrollment is expected to continue with a target enrollment of 300 individuals. Clinical trial information: NCT05716477.
GUARDANT SHIELD
11ms
Guardant Health announces new data to be presented at 2023 Digestive Disease Week showcasing the potential of its blood-based technology to detect colorectal cancer (Businesswire)
"Guardant Health, Inc...is pleased to announce that it will present data from two studies highlighting the performance of its blood-based screening technology to detect early-stage colorectal cancer (CRC), including the acceptance of the ECLIPSE study as a late-breaking abstract, at Digestive Disease Week (DDW) taking place in Chicago, Illinois on May 6-9, 2023."
Late-breaking abstract • Observational data
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GUARDANT SHIELD
12ms
Guardant Health to Present Data From 14 Studies Highlighting Advances in Precision Oncology and Cancer Screening at 2023 AACR Annual Meeting (Businesswire)
"Guardant Health, Inc...announced today that it will present data from 14 studies highlighting advances in precision oncology and cancer screening at the 2023 American Association for Cancer Research (AACR) Annual Meeting, April 14-19 in Orlando, Florida....In particular, studies show that: Methylome sequencing with a liquid-only approach using the GuardantINFINITY platform can quantify circulating tumor DNA level and change with greater sensitivity and precision than genomic sequencing, making longitudinal ctDNA monitoring accessible to a broader range of patients....The analytical validation of the GuardantINFINITY genomic and epigenomic liquid biopsy platform showed its potential for ultra-sensitive ctDNA detection for minimal residual disease and recurrence surveillance, tumor fraction quantitation for therapy monitoring, oncogenic virus detection, immunogenotyping, epigenotyping, and tumor phenotype characterization, representing a new standard in biomarker discovery."
Clinical data
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Guardant360® CDx • GUARDANT SHIELD • GuardantINFINITY™
1year
Guardant Health collaborates with The Ohio State University Comprehensive Cancer Center to study colorectal cancer screening adherence (Businesswire)
"Guardant Health, Inc...has announced support for an investigator initiated study led and conducted by The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC – James) to evaluate patient compliance with a blood-based test for colorectal cancer (CRC) screening. In this study, The Ohio State University Guardant Shield Colorectal Cancer Screening Project, individuals from minority and underserved populations aged 45 and older who are in need of CRC screening will have the option to receive the Shield blood test, administered by a mobile phlebotomist, as part of their engagement with a community health van."
Licensing / partnership
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GUARDANT SHIELD
1year
Highly sensitive blood-based multi-cancer screening device with tiered specificity based on diagnostic workflow (AACR 2023)
This highly-sensitive, integrated, blood-based cancer screening device yields performance on par with currently available screening tests for cancers with screening guidelines (CRC and lung) and clinically meaningful early-stage detection in cancer types without screening guidelines where early intervention can bring clinical benefit, highlighting the ability of this technology to yield clinically meaningful results for the detection of early stage cancer. The performance of this device is under investigation in prospective screening trials.
GUARDANT SHIELD
1year
Guardant Health submits premarket approval application to the U.S. Food and Drug Administration for Shield blood test (Businesswire)
"Guardant Health, Inc...announced that it has submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval (PMA) application for Shield™, Guardant Health’s blood test to screen for colorectal cancer (CRC). The submission is comprised of data from the company’s positive ECLIPSE study, an over 20,000 patient registrational study evaluating the performance of its blood test for detecting colorectal cancer in average-risk adults."
FDA event
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GUARDANT SHIELD
1year
Guardant Health initiates new study to examine the impact of Shield™ blood test to increase screening compliance for colorectal cancer (Guardant Health Press Release)
"Guardant Health, Inc...announced the initiation of a new study to examine patient preference for Shield, Guardant Health’s blood test to screen for colorectal cancer (CRC), and if having the option of a blood test improves patient adherence to screening. The study will be conducted by the Center for Asian Health Equity – University of Chicago Medicine (CAHE-UCM)."
New trial
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GUARDANT SHIELD
1year
U-Screen: Understanding Patient Preference on Colorectal Cancer Screening Options (clinicaltrials.gov)
P=N/A; Not yet recruiting --> Recruiting | Initiation date: Nov 2022 --> Feb 2023
Enrollment open • Trial initiation date
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GUARDANT SHIELD
1year
GUARDANT SHIELD: Submission for FDA approval for CRC in 1Q’ 23 (Guardant Health)
J.P. Morgan 41st Annual Healthcare Conference Presentation: Launch of Shield IVD-CRC in 2024; Submission for FDA approval for lung cancer in 2026
Launch • FDA event
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GUARDANT SHIELD
over1year
New trial
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GUARDANT SHIELD
almost2years
Guardant Health to present new data from its broad portfolio of blood tests at 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Guardant Health Press Release)
"Guardant Health, Inc...announced today it will present new data at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 in Chicago. Among the 19 abstracts are oral presentations highlighting the use of real-world data to identify resistance to early treatment in advanced breast cancer and the use of enhanced biomarker analysis to evaluate progression-free survival data in metastatic breast cancer therapy."
Real-world evidence • Clinical data
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Guardant360® CDx • GuardantOMNI • Guardant360 Response™ • GUARDANT SHIELD • GuardantREVEAL
almost2years
Guardant Health presents new data showing blood test accuracy in detecting colorectal cancer in first-of-its kind prospective study at digestive disease week 2022 (Guardant Health Press Release)
"Guardant Health, Inc...announced data showing its blood-based multimodal test achieved clinically significant thresholds of sensitivity and specificity in detecting colorectal cancer (CRC). These data were presented during an oral presentation at Digestive Disease Week 2022..The assay used in this analysis integrates genomics and epigenomics for CRC detection. An updated version of this assay that incorporates the use of proteomics, Shield™, is now available as a laboratory developed test for eligible individuals by prescription only through healthcare professionals."
Clinical data
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GUARDANT SHIELD
almost2years
Guardant Health announces Shield™ blood test available in US to detect early signs of colorectal cancer in average-risk adults (Guardant Health Press Release)
"Guardant Health, Inc...announced the availability of Shield™, the company’s first blood-based test for the detection of early-stage colorectal cancer (CRC). The test, which only requires patients to complete a simple blood draw, is intended for adults age 45 and older who are not up to date with recommended screening guidelines, show no symptoms, and are at average risk for CRC."
Clinical
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GUARDANT SHIELD
almost2years
Guardant Health presents new data showing blood test highly accurate in detecting multiple cancers at the American Association for Cancer Research Annual Meeting (Guardant Health Press Release)
"Guardant Health, Inc...announced new data demonstrating the ability of the company’s investigational next-generation Guardant SHIELD™ multi-cancer assay to accurately detect early-stage cancers...Data from the presentation show that the next-generation Guardant SHIELD multi-cancer screening assay achieved sensitivity (detection rates) of 90% (n=692) in stages I and II colorectal cancer (CRC) and 87% (n=55) in stages I and II lung cancer. For more advanced cancer (stages III and IV), sensitivity was 93% (n=582) for CRC and 93% (n=136) for lung cancer."
Clinical data
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GUARDANT SHIELD
almost2years
Guardant Health announces partnership with Epic to streamline access to company’s broad portfolio of cancer tests (Guardant Health Press Release)
"Guardant Health, Inc...announced a partnership with Epic...to integrate the company’s broad portfolio of cancer tests with Epic. This integration will make it easier for health systems, community healthcare providers and retail health clinics to make Guardant Health blood tests part of routine clinical care by providing direct ordering access and results delivery...In addition to Guardant SHIELD, clinicians will be able to order current flagship tests such as Guardant360® CDx and Guardant360 Response™ to help physicians inform treatment decisions for patients with advanced cancer, and Guardant Reveal™ to detect residual and recurrent disease in patients with early-stage cancer."
Licensing / partnership
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Guardant360® CDx • Guardant360 Response™ • GUARDANT SHIELD • GuardantREVEAL
2years
Guardant Health to Present New Data from its Broad Portfolio of Blood Tests at the American Association for Cancer Research Annual Meeting (Guardant Health Press Release)
"Guardant Health, Inc...announced...it will present new data from its broad portfolio of blood tests at the American Association for Cancer Research (AACR) Annual Meeting from April 8-13, 2022. Included in the presentation will be data from its multi-cancer screening assay, next-generation Guardant SHIELD."
Clinical data
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GUARDANT SHIELD
2years
Guardant Health enrolls first patient in SHIELD LUNG study to evaluate accuracy of its blood test to detect lung cancer in high-risk adults (Guardant Health Press Release)
"Guardant Health, Inc...announced today the enrollment of the first patient in the SHIELD (Screening for HIgh-frEquency maLignant Disease) LUNG study, a nearly 10,000-patient prospective, registrational study to evaluate the performance of its next-generation Guardant SHIELD blood test in detecting lung cancer in high-risk individuals ages 50-80. The study is anticipated to run in approximately 100 centers in the United States and Europe."
Enrollment open
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GUARDANT SHIELD
2years
GUARDANT SHIELD: Launch of LDT for CRC in 1H 2022 (Guardant Health)
J.P. Morgan 40th Annual Healthcare Conference Presentation: Submission for FDA approval in 2H 2022
Launch • FDA event
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GUARDANT SHIELD