Translating Biomarker Discovery into Companion Diagnostics through Validation and Regulatory Consideration - Genomic Biomarkers for Pharmaceutical Development - page 153

CHAPTER
7
Translating Biomarker
Discovery into Companion
Diagnostics through Validation
and R egulatory Conside ration
Philip Brohawn, Brandon W. Higgs, Koustubh
Ranade, Bahija Jallal, Yihong Yao
MedImmune, LLC, Gaithersburg, Maryland
7.1 INTRODUCTION
Prior to describing strategies for the effective analytical validation and clinical imple-
mentation of a companion diagnostic device, it is important to have a clear understanding
of the most current regulatory guidance on the subject. Currently there are a number of dif-
ferent companion diagnostic approval regulatory pathways that depend upon the geo-
graphical location of implementation and / or development. For example, self certification and
obtaining a CE mark is the path in Europe, while in the United States, the Food and Drug
Administration (FDA) has a more defined regulatory pathway and approval process for
devices. It is widely accepted that the most rigorous of these regulatory pathways is that laid
out by the FDA, and that meeting the requirements of FDA premarket approval will likely be
sufficient to meet the requirements of other regulatory bodies. For this reason we will exam-
ine in greater depth the regulatory path to approval as defined by the FDA.
On July 25, 2011, the FDA's Center for Devices and Radiological Health (CDRH) divi-
sion released a version of draft guidance on companion diagnostics to solicit feedback from
industry [1] . This draft guidance followed July 2007 draft guidance on In vitro Diagnostic
Multivariate Index Assays [2] , and an even earlier April 2005 draft Drug Diagnostic
Co-Development Concept Paper [3] . As the 'Draft Guidance for Industry and Food and Drug
Administration Staff - In vitro Companion Diagnostic Devices' is the most updated guidance,