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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 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 ...
The approval allows the use of the cancer drug, Rybrevant, in combination with J&J's existing drug, lazertinib, as a first-line treatment for non-small cell lung cancer (NSCLC) patients with a ...
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