Companion diagnostics are essential for defining patients' eligibility for specific treatment with a medicinal product through the quantitative or qualitative determination of specific markers identifying subjects at a higher risk of developing an adverse reaction to the medicinal product in question or identifying patients in the population for whom the therapeutic product has been adequately studied, and found safe and effective.
Tá feistí diagnóiseacha coimhdeachta ríthábhachtach chun incháilitheacht othar do chóir leighis shonrach le táirge leighis trí mharcóirí sonracha a chinneadh ar bhonn cainníocht nó cáilíocht lena ndéanfaí na daoine sin atá i mbaol frithghníomh díobhálach i ngeall ar an táirge sonrach leighis i dtrácht a shainaithint nó othair a shainaithint sa daonra a ndearnadh staidéar leordhóthanach ar an táirge teiripeach ina leith agus ar cinneadh go bhfuil sé sábháilte, éifeachtach.