Next-gen­er­a­tion se­quenc­ing: FDA of­fers guid­ance to stream­line path to mar­ket

The FDA on Thurs­day fi­nal­ized two guid­ance doc­u­ments re­lat­ed to next-gen­er­a­tion se­quenc­ing (NGS) and draft­ed new guid­ance on in­ves­ti­ga­tion­al in vit­ro di­ag­nos­tics (IVDs) in on­col­o­gy tri­als – all of which of­fer rec­om­men­da­tions to pro­vide test de­vel­op­ers with a more ef­fi­cient path to mar­ket.

The fi­nal­ized guid­ance doc­u­ments pro­vide NGS test de­vel­op­ers with rec­om­men­da­tions for de­sign­ing, de­vel­op­ing and val­i­dat­ing tests, as well as us­ing ge­net­ic vari­ant data­bas­es to sup­port clin­i­cal va­lid­i­ty.

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