Guardant Health Fda Approved

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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 Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today …

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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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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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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Guardant360® CDx Receives FDA Approval as First and Only …

(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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FDA Approves Blood Tests That Can Help Guide Cancer …

(3 days ago) WEBFDA approved Guardant360 CDx on August 7 and FoundationOne Liquid CDx on August 26. The approvals were based on data from hundreds of patients with a range of cancer types.

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

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Guardant360® CDx: Fastest FDA-Approved Liquid CGP Panel

(8 days ago) WEBGuardant360 tests are covered across 300 million lives with all major insurers, including Aetna, Anthem, Cigna, United Healthcare, and others. *Based on Guardant Health data …

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

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Guardant Health CDx Wins FDA Approval for First Liquid

(3 days ago) WEBNEW YORK – Guardant Health said Friday that the US Food and Drug Administration has approved its targeted next-generation sequencing liquid biopsy …

https://www.genomeweb.com/liquid-biopsy/guardant-health-cdx-wins-fda-approval-first-liquid-biopsy-ngs-tumor-profiling-assay

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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, Inc. - Food and Drug Administration

(3 days ago) WEBGuardant Health, Inc. May 21, 2021. Katie Bessette, Ph.D., RAC Senior Director, Regulatory Affairs 505 Penobscot Drive Redwood City, CA 94063 Be advised that …

https://www.accessdata.fda.gov/cdrh_docs/pdf20/P200010S001A.pdf

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Guardant360 CDx – P200010/S002 FDA

(9 days ago) WEBPMA Applicant: Guardant Health, Inc. Address: 505 Penobscot Drive Redwood City, CA 94063 USA Approval Date: (NSCLC) who may benefit from …

https://www.fda.gov/medical-devices/recently-approved-devices/guardant360-cdx-p200010s002

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Guardant Health Receives FDA Approval for Guardant360

(6 days ago) WEBGuardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, announced today that the U.S. Food and Drug Administration (FDA) has approve

https://www.businesswire.com/news/home/20220811005816/en/Guardant-Health-Receives-FDA-Approval-for-Guardant360%C2%AE-CDx-as-Companion-Diagnostic-for-Daiichi-Sankyo-and-AstraZeneca%E2%80%99s-ENHERTU%C2%AE-for-Treatment-of-NSCLC-Patients-With-Activating-HER2-Mutations

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Guardant Health Announces Tentative Date of FDA Advisory Panel …

(6 days ago) WEBPALO ALTO, Calif., December 19, 2023--Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that the U.S. Food and Drug …

https://finance.yahoo.com/news/guardant-health-announces-tentative-date-210500885.html

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FDA Advisory Panel to Review Guardant's Shield Blood Test

(3 days ago) WEBGuardant Health, a precision oncology company, announced that the US Food and Drug Administration’s Molecular and Clinical Genetics Panel of the Medical …

https://clpmag.com/disease-states/cancer/colorectal/guardant-gives-tentative-date-of-fda-advisory-panel-review-for-shield-blood-test/

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May 23, 2024: Molecular and Clinical Genetics Panel meeting

(Just Now) WEBOn May 23, 2024, the committee will discuss, make recommendations, and vote on information regarding the premarket approval application for the Shield test by …

https://www.fda.gov/advisory-committees/advisory-committee-calendar/may-23-2024-molecular-and-clinical-genetics-panel-medical-devices-advisory-committee-meeting

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FDA Advisory Panel Review of Guardant Health’s Shield - BioSpace

(Just Now) WEBPALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Molecular and …

https://www.biospace.com/article/releases/fda-advisory-panel-review-of-guardant-health-s-shield-blood-test-to-screen-for-colorectal-cancer-to-be-held-on-may-23/

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Guardant360 CDx - P200010/S010 FDA

(9 days ago) WEBGuardant360 CDx is a laboratory test designed to detect gene mutations found in circulating cell-free DNA (cfDNA). This test helps doctors identify people with …

https://www.fda.gov/medical-devices/recently-approved-devices/guardant360-cdx-p200010s010

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FDA Approves Guardant360 CDx for Comprehensive Genomic …

(Just Now) WEBThe FDA has approved Guardant360 CDx for comprehensive genomic profiling in patients with any solid malignant neoplasm, according to Guardant Health, …

https://www.cancernetwork.com/view/fda-approves-guardant360-cdx-for-comprehensive-genomic-profiling-in-all-solid-cancers

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Guardant Health, Inc. - Guardant360® CDx Receives FDA Approval …

(1 days ago) WEBGuardant Health liquid biopsy can help identify the 13 percent of patients harboring the KRAS G12C mutation, a previously undruggable target, who may be …

https://investors.guardanthealth.com/press-releases/press-releases/2021/Guardant360-CDx-Receives-FDA-Approval-as-First-and-Only-Liquid-Biopsy-Companion-Diagnostic-for-Amgens-LUMAKRAS-sotorasib-KRASG12C-Inhibitor-for-Use-in-Advanced-Non-Small-Cell-Lung-Cancer/default.aspx

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Premarket Approval (PMA) - Food and Drug Administration

(9 days ago) WEBA supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure Generic Name: Next …

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P200010S010

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Knoxville residents can try a new blood test to screen for cancer

(7 days ago) WEBThe test, called Shield, is a product of Guardant Health in Silicon Valley. Shield has not yet been approved by the FDA and is not covered by insurance. It currently costs $895 out …

https://www.msn.com/en-us/health/other/knoxville-residents-can-try-a-new-blood-test-to-screen-for-cancer-before-a-colonoscopy/ar-BB1lfTmB

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and …

(Just Now) WEBmake recommendations, and vote on information regarding the premarket approval application for the Shield test by Guardant Health, Inc. The proposed indication for use …

https://public-inspection.federalregister.gov/2024-08656.pdf

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Waiting on OIRA for final LDT rule - POLITICO

(Just Now) WEBThe FDA will convene its Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee on May 23 to discuss Guardant Health’s …

https://www.politico.com/newsletters/prescription-pulse/2024/04/23/waiting-on-oira-for-final-ldt-rule-00153769

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