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A companion diagnostic (CDx) [1] is a diagnostic test used as a companion to a therapeutic drug to determine its applicability to a specific person. [2]Companion diagnostics are co-developed with drugs to aid in selecting or excluding patient groups for treatment with that particular drug based on their biological characteristics that determine responders and non-responders to the therapy.
In January 2024, the FDA approved erdafitinib for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. [12]
In the US, EGFR exon 19 deletions, exon 21 L858R mutations or the T790M status of the patient prior to treatment with osimertinib must be detected by a companion diagnostic test. [4] The Food and Drug Administration (FDA) has approved multiple tests, including FoundationOne CDx for this purpose. [13]
The FDA has given the green light to a self-collection solution to test for HPV, making it one of the easiest options available in the U.S. for identifying those at risk of cervical cancer.
Toxgnostics is part of personalized medicine as it describes the guiding principles for the discovery of pharmacogenomic biomarker tests, also referred to as companion diagnostic tests, which identify if an individual patient is likely to suffer severe drug toxicity from treatment with a specific therapeutic agent. Once at-risk individuals are ...
An infectious disease expert weighs in on when to use these tests at home. Skip to main content. Sign in. Mail. 24/7 Help. For premium support please call: 800-290-4726 more ways to ...
Companion Diagnostic Tests in Oncology Market: Competitive Landscape In the dynamic realm of oncology, companion diagnostic tests play a pivotal role in guiding personalized treatment decisions. The market is fiercely competitive, with key players like Roche Diagnostics, Agilent Technologies, and Foundation Medicine dominating.
Enasidenib was approved by the FDA in August 2017, for relapsed or refractory acute myeloid leukemia (AML) in people with specific mutations of the IDH2 gene, determined by an FDA-approved IDH2 companion diagnostic test. [2] [3] [4]