Contextual Considerations For Companion Diagnostics Clinical Utility

While clinical performance, expressed as sensitivity and specificity, is of obvious importance for the utility of any test, it is important to recognize that with regard to companion diagnostics, a set of specific considerations apply depending on the intended use of the test. In this respect, both the clinical indication and the magnitude of expected benefit from the treatment, and the intended use to either enhance efficacy or avoid adverse reactions, are variables that will greatly influence the requirements for sensitivity and specificity, respectively, of the desired test (Table 4).

Thus, on one end of the spectrum, in life-threatening indications (e.g., oncology, HIV) and in the case of a drug that may be lifesaving, and for which feasible alternatives do not exist, an efficacy marker would be expected to show a high sensitivity (i.e., few false negatives, as they would result in inappropriate withholding of the treatment), but may be acceptable at lower specificity (false positives will result, for an otherwise safe drug, in unnecessary and ineffective treatment). In contrast, a safety marker in such an indication would be required to demonstrate high specificity (i.e., few false positives, which again would result in unnecessary withholding of the treatment), while

TABLE 4 Contextual Considerations Regarding Companion Diagnostics"

Indication

Efficacy Marker

Adverse Event Marker

Sensitivity

Specificity

Sensitivity

Specificity

Serious or life

*

*

*

*

threatening

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