Guardant Health Fda Approved Tests

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FDA Panel Endorses Safety of Guardant Blood Test for Colon …

(9 days ago) WEBThe F.D.A. approved these methods long ago, and research has demonstrated that they are more accurate than the new blood test, Shield, made by Guardant Health of Palo Alto, Calif.

https://www.nytimes.com/2024/05/23/health/colon-cancer-blood-test-guardant.html

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Guardant Health colon cancer test endorsed by FDA …

(1 days ago) WEBFDA approval is a requirement for winning coverage from the Centers for Medicare and Medicaid Services, which could be the difference between Guardant’s …

https://www.statnews.com/2024/05/23/guardant-fda-shield-colon-cancer-blood-screening-panel-recommend/

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Blood test to detect colon cancer could move a step closer to FDA …

(2 days ago) WEBGuardant Health’s Shield tests could be the first approved blood screening test for colorectal cancer that meets requirements for Medicare reimbursement. CNN …

https://www.cnn.com/2024/05/23/health/colon-cancer-blood-test/index.html

Category:  Cancer Show Health

What to know about the blood test to detect colon cancer - ABC …

(1 days ago) WEBGuardant Health, the company that makes Shield, is seeking FDA premarket approval for the test to screen for colorectal cancer among people aged 45 and older at …

https://abcnews.go.com/Health/blood-test-detect-colon-cancer-recommended-fda-panel/story?id=110531552

Category:  Cancer Show Health

FDA Executive Summary - U.S. Food and Drug …

(1 days ago) WEBThe Shield test is a qualitative in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the …

https://www.fda.gov/media/178792/download

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FDA Panel Gives Nod to Blood Test for Colon Cancer

(5 days ago) WEBThe panel voted 7-2 that the benefits outweigh the risks when using the Guardant Health's Shield test for colon cancer. “The advisory committee’s strong …

https://www.healthday.com/health-news/cancer/fda-panel-gives-nod-to-blood-test-for-colon-cancer

Category:  Cancer Show Health

Guardant Health, Inc. - Guardant Health receives FDA approval for

(9 days ago) WEBThe approval as a companion diagnostic for ORSERDU is Guardant Health’s fifth FDA approval for the Guardant360 CDx test and its first in breast cancer. …

https://investors.guardanthealth.com/press-releases/press-releases/2023/Guardant-Health-receives-FDA-approval-for-Guardant360-CDx-as-companion-diagnostic-for-Menarini-Groups-ORSERDU-for-treatment-of-patients-with-ESR1-mutations-in-ER-HER2--advanced-or-metastatic-breast-cancer/default.aspx

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Guardant Health, Inc. - Guardant Health Receives FDA Approval for

(3 days ago) WEBBlood test provides simple way to test patients comprehensively for tumor alterations that drive selection of targeted therapies, now including ENHERTU Guardant …

https://investors.guardanthealth.com/press-releases/press-releases/2022/Guardant-Health-Receives-FDA-Approval-for-Guardant360-CDx-as-Companion-Diagnostic-for-Daiichi-Sankyo-and-AstraZenecas-ENHERTU-for-Treatment-of-NSCLC-Patients-With-Activating-HER2-Mutations/default.aspx

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Guardant360® CDx Receives FDA Approval as First and …

(7 days ago) WEBREDWOOD CITY, Calif.--(BUSINESS WIRE)--Guardant Health, Inc. (Nasdaq: GH) announces that the U.S. Food and Drug Administration (FDA) has …

https://www.businesswire.com/news/home/20210528005396/en/Guardant360%C2%AE-CDx-Receives-FDA-Approval-as-First-and-Only-Liquid-Biopsy-Companion-Diagnostic-for-Amgen%E2%80%99s-LUMAKRAS%E2%84%A2-sotorasib-KRASG12C-Inhibitor-for-Use-in-Advanced-Non-Small-Cell-Lung-Cancer

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U.S. FDA advisers back approval for Guardant's blood-based …

(5 days ago) WEBGuardant's application for Shield was based on a study that showed the test detected 83% of colorectal cancers, while Exact's Cologuard had 92.3% sensitivity rate, …

https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-back-approval-guardants-blood-based-cancer-test-2024-05-23/

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FDA panel recommends approval of a blood test for colon cancer

(3 days ago) WEBMay 23, 2024, 2:47 PM PDT. By Reuters. Advisers to the U.S. Food and Drug Administration on Thursday recommended for the approval of Guardant Health’s blood …

https://www.nbcnews.com/health/cancer/fda-panel-recommends-blood-test-colon-cancer-rcna153832

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Tests for Cancer Screening - GuardantHealth

(3 days ago) WEBThis test has demonstrated to be accurate at detecting colorectal cancer by identifying circulating tumor DNA (ctDNA) in the blood. 20. Our ECLIPSE study validates Shield™ …

https://guardanthealth.com/products/tests-for-cancer-screening/

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Guardant preps for FDA review of colorectal cancer blood test

(9 days ago) WEBGuardant Health preps for FDA advisory panel review of its blood-based colorectal cancer screening test. Technically, Shield has been available to the public …

https://www.fiercebiotech.com/medtech/guardant-health-preps-fda-advisory-panel-review-its-blood-based-colorectal-cancer-screening

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FDA Approves Blood Tests That Can Help Guide Cancer Treatment

(3 days ago) WEBIn this case, the tests determine whether a patient’s tumor has a genetic change that is targeted by a specific drug. Guardant360 CDx, made by Guardant …

https://www.cancer.gov/news-events/cancer-currents-blog/2020/fda-guardant-360-foundation-one-cancer-liquid-biopsy

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Tests for Patients with Early and Advanced Stage Cancer

(2 days ago) WEBIn the event the test is not fully covered by insurance, patients may be eligible for financial assistance based on medical and financial need. To learn more, contact Guardant …

https://guardanthealth.com/products/tests-for-patients-with-early-and-advanced-stage-cancer/

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ShieldTM blood-based colorectal cancer screening test

(7 days ago) WEBThe Shield blood test* uses a multimodal approach, integrating genomics, epigenomics and proteomics, to achieve high sensitivity and specificity in detecting early signs of …

https://guardanthealth.com/wp-content/uploads/Guardant_Shield_FactSheet-1.pdf

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FDA Advisory Panel Review of Guardant Health’s Shield™ Blood …

(1 days ago) WEBGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Molecular and Clinical Genetics Panel of the U.S. Food …

https://investors.guardanthealth.com/press-releases/press-releases/2024/FDA-Advisory-Panel-Review-of-Guardant-Healths-Shield-Blood-Test-to-Screen-for-Colorectal-Cancer-to-Be-Held-on-May-23/default.aspx

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FDA panel gives nod to blood test for colon cancer - Medical Xpress

(2 days ago) WEBThis issue was also raised by FDA staff in briefing documents. Guardant's application for approval was based on a study that showed the test detected 83% of …

https://medicalxpress.com/news/2024-05-fda-panel-blood-colon-cancer.html

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FDA Advisory Panel Review of Guardant Health’s Shield™ Blood …

(Just Now) WEBPALO ALTO, Calif., April 22, 2024--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Molecular and Clinical Genetics …

https://finance.yahoo.com/news/fda-advisory-panel-review-guardant-125200837.html

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Tests for Patients with Advanced Cancer - GuardantHealth

(4 days ago) WEBThe first FDA-approved blood test for complete genomic testing. Since introduced, Guardant Health’s blood tests have become widely accepted for blood-based complete …

https://webmail.guardanthealth.com/products/tests-for-patients-with-advanced-cancer/

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FDA Approves First Liquid Biopsy Next-Generation Sequencing …

(7 days ago) WEBThe FDA granted approval for the Guardant360 CDx test to Guardant Health. The FDA, an agency within the U.S. Department of Health and Human …

https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test

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Guardant360® CDx: Fastest FDA-Approved Liquid CGP Panel

(7 days ago) WEBPatients. Blood-Based Screening. Information. For Guardant360 CDx: Guardant360® CDx is the fastest FDA-approved CGP panel for all advanced solid tumors including lung, …

https://www.guardantcomplete.com/products/guardant360-cdx

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Guardant Health, Inc. - Guardant Health submits premarket …

(2 days ago) WEBGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that it has submitted to the U.S. Food and Drug …

https://investors.guardanthealth.com/press-releases/press-releases/2023/Guardant-Health-submits-premarket-approval-application-to-the-U.S.-Food-and-Drug-Administration-for-Shield-blood-test/default.aspx

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FDA Advisory Panel Supports Approval Of Guardant Health's …

(9 days ago) WEBThursday, the Molecular and Clinical Genetics Panel of FDA’s Medical Devices Advisory Committee recommended FDA approval of Guardant Health Inc’s …

https://markets.businessinsider.com/news/stocks/fda-advisory-panel-supports-approval-of-guardant-health-s-blood-test-for-colorectal-cancer-screening-1033419799

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Panel recommends blood test to detect colon cancer for FDA …

(4 days ago) WEBThe FDA will review the panel discussions and voting outcomes in deciding whether or not to approve the test. If approved, Shield will be the second-blood-based …

https://www.upi.com/Health_News/2024/05/23/fda-approval-colon-cancer-blood-test/3471716507476/

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Guardant360 CDx – P200010/S008 FDA

(9 days ago) WEBGuardant360 CDx is a laboratory test for gene mutations in cfDNA. This approval is for detecting ERBB2 activating mutations (SNV and exon 20 insertions).

https://www.fda.gov/medical-devices/recently-approved-devices/guardant360-cdx-p200010s008

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Guardant Health Stock Jumps. Blood Test for Cancer Moves …

(6 days ago) WEBThe FDA is expected to decide whether to approve Shield later this year. Guardant stock was up 12% to $25.31 in trading Friday, while the S&P 500 rose 0.7%. Write to Emily …

https://www.msn.com/en-us/health/other/guardant-health-stock-jumps-blood-test-for-cancer-moves-toward-fda-approval/ar-BB1mZa6u

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Guardant Health, Inc. - Guardant Health Announces Tentative Date …

(5 days ago) WEBGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug Administration’s Molecular and …

https://investors.guardanthealth.com/press-releases/press-releases/2023/Guardant-Health-Announces-Tentative-Date-of-FDA-Advisory-Panel-Review-of-Shield-Blood-Test/default.aspx

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Guardant Health Jumps — As Exact Sciences Slumps — On A Key …

(4 days ago) WEBGuardant Health stock jumped Friday after a Food and Drug Administration panel recommended the agency approve Guardant's blood-based colon cancer …

https://www.investors.com/news/technology/guardant-health-stock-fda-advisory-committee-blood-based-colon-cancer-screening-test-shield/

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