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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.
The Food and Drug Administration (FDA) has recently approved a blood test screening for colorectal cancer that has an over 83% success rate at detecting the presence of this form of cancer.
The Food and Drug Administration on Monday approved Guardant Health’s blood test, called Shield, to screen for colon cancer. The test isn't meant to replace colonoscopies, but is generating ...
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]
A new blood test to screen for colon cancer was approved Monday by the Food and Drug Administration (FDA), aimed at finding cancer when it’s still in the early stage and treatable. The blood ...
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