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Figure 2 Drug-diagnostics collaboration scenarios.

TABLE 1 Current Pharmacogenomics Examples

Drug

Efficacy Test

Safety Test

Trastuzumab (Herceptin)"

Imatinib mesylate (Gleevec)" Cetuximab, Panitumumab" Imatinib mesylate (Gleevec)" Gefitinib Irinotecan"

6MP and azathioprine" 5-HT3R antagonist, codeine derivative Warfarin"

HER-2/neu IHC and

FISH' C-kit IHC' EGFR IHC' bcr/abl or 9:22 tr EGFR mutations

UGT1A1 mut' TPMT

CYP450(2D6) mut' CYP2C9&VKORC1'

"FDA drug package insert cites the relevant test. 'FDA cleared/approved device in reference to the drug.

examples. This document is intended primarily to provide direction for the development of diagnostics that are used to select or avoid drugs (predictive tests). A predictive test/biomarker would be defined as a single trait or a signature of traits that separates different populations with respect to the outcome of interest in response to a particular (targeted) treatment (e.g., response to Herceptin, Erbitux, Panitumumab).

Predictive tests could be categorized into three classes: (1) a predictive test for efficacy, to identify patients most likely to respond beneficially to a targeted treatment; (2) a predictive test for safety, to identify patients most likely to respond adversely to a targeted treatment; and (3) a predictive test for dosing, to identify a patient's specific dosing to optimize the benefit of or minimize the risk of a targeted treatment.

Following Sargent et al. [8] , a predictive biomarker provides information about the effect of treatment and is useful for selecting patients for the drug. In this document, diagnostic tests are assumed to be predictive biomarkers. However, much of the discussion also applies to a prognostic test or biomark-ers defined as follows: A prognostic biomarker (e.g., risk for cancer recurrence) is a single trait or a signature of traits that separates different populations with respect to the risk of an outcome of interest in the absence of treatment or despite nontargeted "standard" treatment.

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