title: Current Status of Companion and Complementary Diagnostics: Strategic Considerations for Development and Launch.
abstract: US Food and Drug Administration (FDA)-approved diagnostic assays play an increasingly common role in managing patients to prolong lifespan while also enhancing quality of life. Diagnostic assays can be essential for the safe and effective use of therapeutics (companion diagnostic), or may inform on improving the benefit/risk ratio without restricting drug access (complementary diagnostic). This tutorial reviews strategic considerations for drug and assay development resulting in FDA-approved companion or complementary diagnostic status.
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: H
authors.initials: H
authors.lastname: Scheerens
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: A
authors.initials: A
authors.lastname: Malong
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: K
authors.initials: K
authors.lastname: Bassett
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: Z
authors.initials: Z
authors.lastname: Boyd
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: V
authors.initials: V
authors.lastname: Gupta
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: J
authors.initials: J
authors.lastname: Harris
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: C
authors.initials: C
authors.lastname: Mesick
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: S
authors.initials: S
authors.lastname: Simnett
authors.affiliation: Roche AG, Basel, Switzerland.
authors.forename: H
authors.initials: H
authors.lastname: Stevens
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: H
authors.initials: H
authors.lastname: Gilbert
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: P
authors.initials: P
authors.lastname: Risser
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: R
authors.initials: R
authors.lastname: Kalamegham
authors.affiliation: Roche AG, Basel, Switzerland.
authors.forename: J
authors.initials: J
authors.lastname: Jordan
authors.affiliation: Roche AG, Basel, Switzerland.
authors.forename: J
authors.initials: J
authors.lastname: Engel
authors.affiliation: Roche AG, Basel, Switzerland.
authors.forename: S
authors.initials: S
authors.lastname: Chen
authors.affiliation: Pharmaceutical Sciences, Roche Pharma Research and Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche, Ltd, Basel, Switzerland.
authors.forename: L
authors.initials: L
authors.lastname: Essioux
authors.affiliation: Genentech Inc., San Francisco, California, USA.
authors.forename: J A
authors.initials: JA
authors.lastname: Williams
mesh_terms: D015415:Biomarkers / Q000032:analysis; D000529:Complementary Therapies / Q000331:legislation & jurisprudence*; D019937:Diagnostic Techniques and Procedures / Q000191:economics; D006297:Health Services Accessibility; D006801:Humans; D007349:Insurance, Health, Reimbursement; D058990:Molecular Targeted Therapy / Q000379:methods; D009369:Neoplasms / Q000188:drug therapy*; D057285:Precision Medicine / Q000191:economics / Q000379:methods*; D011788:Quality of Life; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*
chemical_list: D015415:Biomarkers