The FDA approved the first liquid biopsy using NGS technology.

Guardant Health announced Wednesday that the FDA has approved the company's development of liquid biopsy Guardant 360 CDx for comprehensive genomic analysis of all solid tumor types.
meanwhile, the FDA approved Guardant 360 CDx as an accompanying test to identify patients with specific types of mutations in the epiderm growth factor receptacle (EGFR) gene in patients with metastatic non-small cell lung cancer (NSCLC).
is the first FDA-approved diagnostic test that combines NGS and liquid biopsy technology to guide treatment decisions.
Guardant360 CDx has been awarded breakthrough medical device recognition by the FDA.
it uses two techniques.
is a liquid biopsy, which uses blood samples to provide healthcare professionals with genetic information about a patient's tumor.
is less invasive and more repeatable than standard tissue biopsies.
, liquid biopsies can be used in situations where standard tissue biopsies are not feasible, such as where tumor location is not suitable for tissue biopsies.
the second technique is next-generation sequencing (NGS), which uses NGS to detect mutations in 55 tumor genes at the same time, rather than one at a time.
it allows clinicians to better assess the multiple genetic mutations that tumors carry.
of the Guardant360 CDx is based on clinical and analytical validation of more than 5,000 samples.
in a retrospective analysis of data from the key Phase 3 clinical trials FLAURA and AURA3, The non-progressive survival rate of non-small cell lung cancer patients treated with Tagrisso (osimertinib) was determined using Guardant360 CDx consistent with the progression-free survival rate determined using traditional biomarker testing.
Tagrisso is an FDA-approved treatment for metastatic NSCLC.
lung cancer is the leading cause of cancer-related death in the world, and NSCLC is the most common type of lung cancer.
FDA approval of Guardant 360 CDx is an important milestone that demonstrates the value of liquid biopsies to oncologists and, more importantly, to cancer patients.
traditional tissue biopsy-based tumor analysis is often invasive and requires longer turnaround times.
We applaud the FDA's cooperative review process and approval of the first liquid biopsy that can conduct a comprehensive genome mapping analysis," said Dr. Helmy Eltoukhy, CEO of Guardant Health.
" Reference: s1. Guardant Health Guardant360® CDx First FDA-Approved Liquid Biopsy for Comprehensive Tumor Mutation Profiling Across All Solid Cancers. Retrieved August 7, 2020, from FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Companion Diagnostic. Retrieved August 7, 2020, from Note: This article is intended to present advances in medical health research, not treatment options.
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