Roche's FoundationOne CDx Receives FDA Approval as Companion Diagnostic to Identify MSI-H Solid Tumor Patients Eligible for Keytruda Therapy

News on February 21, 2022 /BioValleyBIOON/ -- Roche's cancer genomics company, Foundation Medicine, recently announced that the U.S. Food and Drug Administration (FDA) has approved FoundationOne CDx (F1CDx, cancer genomic profiling test):Used as a companionDiagnosisA product used to identify patients with high microsatellite instability (MSI-H) solid tumors who may be suitable for treatment with Merck's anti-PD-1 therapy Keytruda (generic name: pembrolizumab).

Notably, F1CDx is the first and only one approved by the United StatesFDAApproval to help identify MSI-H solid tumor patients who may be suitable for treatment with KeytrudaDiagnosisProduct.

In tumors defined as MSI-H, there are defects in the DNA repair mechanism, therefore,TumorCells can acquire a large number of mutations that enable them to be recognized by the immune system. MSI-H status is more common in colorectal cancer, endometrial cancer, and gastrointestinal cancer, but it can also be seen in other types of cancer.

Keytruda was approved by the United States in May 2017FDAAccelerated approval for the treatment of certain MSI-H solid tumor patients, making it the first therapy based on genomic features rather than location in the body.TumorTargeted therapy for the site of origin.

Previously, the United StatesFDAF1CDx has been approved as a companionDiagnosisProduct, used for identifying highTumorPatients with high tumor mutational burden (TMB-H) solid tumors who may be eligible for treatment with Keytruda.

F1CDx is a next-generation sequencing-basedIn Vitro DiagnosticsEquipment that utilizes DNA isolated from a patient's tumor tissue to detect and analyze substitutions, insertions and deletions (indels), copy number alterations (CNA), selected gene rearrangements, and including microsatellite instability (MSI) andTumorGenomic signature, including Tumor Mutational Burden (TMB)。

F1CDx is a groundbreaking companionDiagnosisThe product was the first to receive approval in the United States at the end of November 2017.FDAApproval: This approval is hailed as a significant milestone in the field of precision medicine. The F1CDx can simultaneously detect multiple biomarkers certified by regulatory authorities for clinical use.GeneticsMutation, surpassing the previous "one drug, one test" model. (Bioon.com)

Source of the original text:U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for KEYTRUDA® (pembrolizumab) to Identify Patients with Microsatellite Instability-High (MSI-H) Solid Tumors