Companion diagnostics in oncology: 20 years of FDA-approved assays reviewed
This review traces the evolution of FDA-approved companion diagnostics from the first approval to the current landscape of 21 assays governing anticancer drug use. The authors examine how these assays function both during drug development and as post-approval treatment decision tools, highlighting their regulatory framework and clinical impact. A concise overview for professionals navigating the companion diagnostic regulatory landscape.
The original study
Clinical and Regulatory Aspects of Companion Diagnostic Development in Oncology.
- Authors
- Jørgensen JT, Hersom M
- Journal
- Clinical pharmacology and therapeutics
- Type
- Journal Article, Review
- PMID
- 29197081
Original abstract
Nearly 20 years have passed since the US Food and Drug Administration (FDA) approved the first companion diagnostic and today this type of assay governs the use of 21 different anticancer drugs. The regulators deem these assays essential for the safe and effective use of a corresponding therapeutic product. The companion diagnostic assays are important both during the drug development process as well as essential treatment decision tools after the approval of the drugs.