Roche's ROS1+ can­cer drug gets FDA green­light for Foun­da­tion Med­i­cine's com­pan­ion di­ag­nos­tic

More than four years af­ter Roche bought Igny­ta, ac­quir­ing a drug — en­trec­tinib — that scored FDA ap­proval about 18 months lat­er, Roche now has a com­pan­ion di­ag­nos­tic to pair with that drug and ex­pand treat­ment op­tions.

Roche said in a state­ment Thurs­day that the FDA ap­proved a com­pan­ion di­ag­nos­tic from Foun­da­tion Med­i­cine for en­trec­tinib, which is cur­rent­ly be­ing mar­ket­ed as Ro­z­lytrek. The di­ag­nos­tic, called sim­ply Foun­da­tionOne CDx, is es­sen­tial­ly a ge­nom­ic pro­fil­ing tis­sue biop­sy test. Ac­cord­ing to Roche, it can iden­ti­fy the unique “fin­ger­print” of a sol­id tu­mor.

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