title: Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals.
abstract: Companion diagnostics are essential for the safe and effective use of the corresponding therapeutic products. The US FDA has approved a number of companion diagnostics used to select cancer patients for treatment with contemporaneously approved novel therapeutics. The processes of co-development and co-approval of a therapeutic product and its companion diagnostic have been a learning experience that continues to evolve. Using several companion diagnostics as examples, this article describes the challenges associated with the scientific, clinical and regulatory hurdles faced by FDA and industry alike. Taken together, this discussion is intended to assist manufacturers toward a successful companion diagnostics development plan.
authors.affiliation: Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH, US FDA, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, USA.
authors.forename: Donna M
authors.initials: DM
authors.lastname: Roscoe
authors.forename: Yun-Fu
authors.initials: YF
authors.lastname: Hu
authors.forename: Reena
authors.initials: R
authors.lastname: Philip
mesh_terms: D018795:Device Approval; D057069:Diagnostic Test Approval; D006801:Humans; D025202:Molecular Diagnostic Techniques; D057089:Pathology, Molecular / Q000331:legislation & jurisprudence / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration
keywords: FDA; approval; cancer; companion diagnostics; personalized medicine