FDA clears next-gen tu­mor se­quenc­ing test from Memo­r­i­al Sloan Ket­ter­ing

The FDA on Wednes­day an­nounced it has cleared a next-gen­er­a­tion se­quenc­ing (NGS) test de­vel­oped by Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter that can de­tect 468 unique gene mu­ta­tions and oth­er mol­e­c­u­lar bio­mark­ers in a pa­tient’s tu­mor.

The test, re­ferred to as MSK-IM­PACT (In­te­grat­ed Mu­ta­tion Pro­fil­ing of Ac­tion­able Can­cer Tar­gets), was al­ready ap­proved for use with sam­ples from pa­tients in New York by the New York State De­part­ment of Health un­der its clin­i­cal lab­o­ra­to­ry eval­u­a­tion pro­gram.

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