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Introduction: The FDA approved the liquid biopsy Guardant 360 CDx for comprehensive genomic analysis of all solid tumor types.
. Recently, the FDA approved the liquid biopsy Guardant 360 CDx developed by Gunant Health for comprehensive genomic analysis of all solid tumor types, and the FDA approved Guardant 360 CDx as an accompanying test to identify patients with specific mutations in the metastasis non-small cell lung cancer (NSCLC) gene.
recent years, the FDA has approved several tissue-based NGS analyses for tumor analysis and specific accompanying diagnostic requirements.
, theGuardant360 CDx is the first FDA-approved diagnostic test that combines NGS with liquid biopsy technology and guides treatment.
the test developed by Guardant Health has been sold and used in the United States without FDA approval.
This time, Guardant360 was officially approved for comprehensive genomic analysis of all solid tumor types, essentially analyzing and detecting all target mutations carried by any kind of solid tumor, giving Guardant the opportunity to identify its testing methods as a reliable option before other liquid biopsy products are approved by regulators.
many oncologists and researchers are skeptical of liquid biopsies, arguing that while liquid biopsies are faster and cheaper than tissue biopsies, they are less accurate than tissue biopsies.
guidelines from the European Society of Oncology (ESMO) and the National Comprehensive Cancer Network (NCCN) recommend that this method be used only if the tumor is not suitable for a biopsy or if there is not enough tissue to collect it.
up to 25% of cancer patients fall into this category.
, the FDA's approval does not require doctors to assess the feasibility of an organizational biopsy before using Theguardant360.
FDA approval will help speed up the recommendation of the guidelines for the use of this blood test in all patients, increase the number of patients with advanced cancer who receive potentially life-changing treatments, and pave the way for new accompanying diagnostic methods.
's defeat, Guardant Health NGS Liquid Biopsy products were the first to be approved in the pan-cancer liquid biopsy competition, Roche and Gunant Health were the most promising competitors, and on August 7th Guardant 360 CDx was the first to be approved.
Guardant 360 CDx has not only been approved for comprehensive genomic analysis of all solid tumor types, but the FDA has also separately approved Guardant 360 CDx as an auxiliary diagnostic method for AstraZeneca's lung cancer drug Tagrisso®®.
, a global leader in diagnosis, was somewhat surprising that it failed to win the first place in pan-cancer.
One Liquid, a pan-tumor blood testing tool developed before it was acquired by Roche, has filed an application with the U.S. Food and Drug Administration (FDA) and is expected to be approved by the end of the year.
, Grail has raised more than $1.9 billion through four rounds of financing since splitting its independent operations from Illumina.
company's Gallei tests have been conducted in several large cancer trials, but they are not yet available.
other companies are also conducting pan-physical tumor trials and are actively seeking FDA approval.
in this competition, Guardant will have to take advantage of its first-in-the-place advantage to seize the market.
Note: This form has been compiled by the authors, and the timely and effective diagnosis and treatment of tumors has become a priority for the precision medicine industry at a time when tumor morbidity and mortality are on the rise.
liquid biopsy is one of the core technologies of precision medicine, which has great potential in the early sieve, early diagnosis, treatment and prognosis of tumors, and is expected to solve the problem of diagnosis and treatment of tumors throughout the cycle.
NGS liquid biopsy product was approved by the FDA, the industry is of great significance.
NGS-based tumor detection products in China have been approved by NMPA, are based on tissue biopsy diagnostic reagents.
NGS liquid biopsy products based on blood samples are still in the process of being developed.
the FDA approved this type of product on the market, it is expected to speed up the process of domestic approval of related products.
reference source 1. FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test.2. Guardant pips Roche to liquid biopsy approval.