?????·??|?§??????????????o??o|è???o¤??????A???è??????????????PD-L1??????è???????????????????????????-|?3???????è'§??· SK006???è?·?????'é??è????-???CDx???C?±?IVDRè?¤è?????è??CDx???????1?????·2??????CE-IVD???????????¨??§???é??????????°??1?????°?????§???????¤?è????-???????3????IVDR???è|??±??·2????????°è?¤è?????
PD-L1??????è???????????????????????????-|?3???????è'§??·SK006?????¨?o???????è??????????????é???2????????????? PD-1????3?KEYTRUDA??????????????????????????1???????????????è?????????????? PD-1????3? LIBTAYO?????è???±3???????????????2?2????????????????è???????????IVDRè?¤è????-??????è|???????KEYTRUDA????o???a??'é??è????-é???o???????é???°????è??è?o??????NSCLC???????°?è·??????????????¤'é??é?¨é3???????è????????é??????????????é?'??§?13è?o??????TNBC???????-¤?¤????IVDRè?¤è??è????????LIBTAYO???NSCLC???
è?????20 ?1'é?????????????¨??°é????????é???¤§??????????§??-|è???-??a???o?????°?o???1??'??°?3?è§????é???±????????????????????¤??§?????????¨??°????????-?????¨?????§è?????IVDR ???è§???§è?¤è???????o?o???§????????????????·????è????????è??????????????IVDR???è§???§è?¤è??é??è???±??¤oè???o?è????-?·????????¨???-????????¨??°????????¨??§??? ????????????????·????è????????è?????è????-?????????
PD-L1??????PD-1????3??2?????o??-??????3é?????????????????????????·??|???PD-L1??????è???????????????????????????-|?3????è?????????-|???éa???¤?1??3???¨?o?è???????????????2????????????????è??????????????è?????è???¤????è????¤?-|???é???????¨???PD-1????3??2???????è??????3??1?è??è????¨?o?è?????è???¤???????????§??±????è?????IVDRè?¤è??è???????????????·????è????????è????§??-???è??????????-è?·???????1?????????±????·2??????é???o?????????3é??è????-è????????
?????·??|è????-?????o???????-|?o????é?¨???è??Sam Rahaè?¨?¤o???a????'é??è????-??????????????????????-|???éa???¤?????3é??è????-?o§??????é????1è?·????o?é??????2?????????????è????????????????'?????°???????????????a??
?????·??|??¨???è'¨é??????3?è§??o????é?¨é???o§??????è??Jenipher Daltonè?????é?????a????¨è?·????-¤???C?±?CDx??¨??°IVDRè?¤è?????????????·??|?°???§??-è?'????o???o??§?'2??????éa???¤??????é??è'¨é?????è§???3??1??????é???|??o??????????????·????è????????è?????a??
?????·??|?????oè??????????°é?????è???????????50????1'?????°??????éa??????¨??o?o???????è?·FDA??1????????'é??è????-?o§???????1???§??-??????è?????????????'???????????????????????§è????o??????CDx?o§??????
1 KEYTRUDA?????é????????Rahway, NJ, USA????-???????é???2???????è??????3¨????????????
2 LIBTAYO?????????????????è???????????Regeneron Pharmaceuticals, Inc???????3¨????????????