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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 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]
In August 2018, the US FDA updated the prescribing information for pembrolizumab to require the use of an FDA-approved companion diagnostic test to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. [75]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
The first edition was published by the WHO on 15 May 2018, and complements the WHO Model List of Essential Medicines (EML), which was published more than 40 years earlier. [1] [8] More than 150 countries have adapted the WHO Model List of Essential Medicines. [7] A second edition was published in July 2019, [3] and a third in 2020. [4]
A medical test is a medical procedure performed to detect, diagnose, or monitor diseases, disease processes, susceptibility, or to determine a course of treatment. The tests are classified by speciality field, conveying in which ward of a hospital or by which specialist doctor these tests are usually performed.
Midostaurin was approved by the FDA in April 2017 for the treatment of adult patients with newly diagnosed AML who are positive for oncogenic FLT3, in combination with chemotherapy. [15] The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML.
Pemigatinib was approved for use in the United States in April 2020 along with the FoundationOne CDX (Foundation Medicine, Inc.) as a companion diagnostic for patient selection. [ 8 ] [ 9 ] [ 12 ]
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