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Companion diagnostic

A companion diagnostic is a test which is developed specifically to aid decision-making in relation to the prescribing of a particular drug.

The companion diagnostic may form part of the product label or data-sheet such as the need to perform a test for over-expression of the human epidermal growth factor 2 (HER-2) in a tumour prior to prescribing the anticancer drug, trastuzumab.

Other examples (not necessarily required by the drug licence) include:

 (i)  Testing for HLA-B*5701 in patients with HIV to avoid the hypersensitivity reaction associated with treatment by abacavir

(ii)  Testing for whether a breast cancer is oestrogen receptor positive or negative prior to prescribing treatment with tamoxifen (which binds to the oestrogen receptor) -recurrences are lower where the breast cancer is oestrogen receptor positive.

Teaching Genetics