Foundation Medicine's new liquid biopsy test receives breakthrough device designation
Release time:
2018-04-20
Every cancer is unique, and every tumor can change at a molecular level. A single genomic test can reveal the DNA changes that drive cancer growth to help determine appropriate personalized treatment options based on a tumor's unique genomic profile.
Every cancer is unique, and every tumor can change at a molecular level. A single genomic test can reveal the DNA changes that drive cancer growth to help determine appropriate personalized treatment options based on a tumor's unique genomic profile.
Next-generation sequencing (NGS) can be used to analyze cancer specimens for all four categories of genomic alterations (base substitutions, insertions and deletions, copy number changes, and rearrangements) known to be associated with solid tumors, sarcomas, and hematologic malignancies. This new liquid biopsy test developed by Foundation Medicine is an NGS in vitro diagnostic device that uses circulating cell-free DNA (cfDNA) isolated from plasma derived from peripheral whole blood to detect genomic alterations as well as genomic signatures (MSI and bTMB). Foundation Medicine plans to use the test as a companion diagnostic to identify those patients who may benefit from targeted therapies and to provide tumor mutation analysis for patients with malignancies.
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