The Ever-Evolving Role of “Companion Diagnostics”

Since 2004, the Food and Drug Administration (FDA) has focused on the concept of the “critical path” initiative — the agency’s effort to stimulate and facilitate the modernization of the sciences through which FDA-regulated products are developed, evaluated and manufactured. As part of this initiative, FDA has highlighted the potential of genetic/genomic testing to create targeted drug and biologic therapies. To that end, the agency has issued guidance documents and concept papers addressing both the procedural and scientific issues that may be considered in the development of drugdiagnostic test combinations, or “companion diagnostic tests” using genomic data. Whether companion diagnostics are used to identify and select patients who may benefit from (or avoid) specific therapies, adjust drug dosage or frequency of administration or predict the likelihood of disease progression or recurrence, these tests reflect the true promise of personalized medicine — the provision of individually safe and effective treatment.

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