Tag: Guardant Health

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Shield MCD Test Gets Breakthrough Device Designation

Guardant Health's Shield MCD test has received FDA Breakthrough Device designation for its ability to detect multiple cancer types.

Hereditary Cancer Testing to Identify Disease Risk Launched
FDA Advisory Committee Panel Recommends Approval of Colorectal Blood Test
Guardant Gives Tentative Date of FDA Advisory Panel Review for Shield Blood Test
Liquid Biopsy May Guide Colon Cancer Adjuvant Treatment
Guardant Health and Ohio State University to Study Colon Cancer Screening Adherence
Guardant Health Submits FDA Premarket Approval Application for Colon Cancer Blood Test
FDA Approves Guardant Health’s CDx Liquid Biopsy for Breast Cancer Patients
Guardant Health Announces Results from Blood Test Study for Colorectal Cancer Detection
Guardant Health Streamlines Access to Cancer Test Portfolio Through New Partnership

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Guardant360 CDx Test Gets ADLT Status from CMS

The Guardant360 CDx test is the first FDA-approved liquid biopsy for comprehensive tumor mutation profiling across all solid cancers.

Guardant Health Raising Awareness of Importance of Complete Biomarker Testing for Advanced Colorectal Cancer
Advances in Liquid Biopsy
‘Coming into Their Own’: FDA Approval of Liquid Biopsy Tests Puts Early, Less Invasive Cancer Detection in Broader Reach
Streck Cell-Free DNA BCT Gets FDA De Novo Clearance
FDA Approves First Liquid Biopsy NGS Companion Diagnostic
Guardant Health, Janssen to Develop Liquid Biopsy Companion Diagnostic

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Decision Expands Guardant360 Coverage to Most Solid Tumor Types

The draft LCD applies to advanced cancer patients who are covered by Medicare for next-generation sequencing of tumor tissue, but have insufficient or unavailable tissue samples.

Tag: Guardant Health

All

Shield MCD Test Gets Breakthrough Device Designation

Hereditary Cancer Testing to Identify Disease Risk Launched

FDA Advisory Committee Panel Recommends Approval of Colorectal Blood Test

Guardant Gives Tentative Date of FDA Advisory Panel Review for Shield Blood Test

Liquid Biopsy May Guide Colon Cancer Adjuvant Treatment

Guardant Health and Ohio State University to Study Colon Cancer Screening Adherence

Guardant Health Submits FDA Premarket Approval Application for Colon Cancer Blood Test

FDA Approves Guardant Health’s CDx Liquid Biopsy for Breast Cancer Patients

Guardant Health Announces Results from Blood Test Study for Colorectal Cancer Detection

Guardant Health Streamlines Access to Cancer Test Portfolio Through New Partnership

All

Guardant360 CDx Test Gets ADLT Status from CMS

Guardant Health Raising Awareness of Importance of Complete Biomarker Testing for Advanced Colorectal Cancer

Advances in Liquid Biopsy

‘Coming into Their Own’: FDA Approval of Liquid Biopsy Tests Puts Early, Less Invasive Cancer Detection in Broader Reach

Streck Cell-Free DNA BCT Gets FDA De Novo Clearance

FDA Approves First Liquid Biopsy NGS Companion Diagnostic

Guardant Health, Janssen to Develop Liquid Biopsy Companion Diagnostic

All

Decision Expands Guardant360 Coverage to Most Solid Tumor Types

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