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.

In con­junc­tion with the an­nounce­ment, FDA al­so laid out a new frame­work for clear­ing NGS-based tu­mor pro­fil­ing tests based on rec­om­men­da­tions from ac­cred­it­ed third-par­ty re­view­ers, the first of which is NYS­DOH.

“The goal of al­low­ing NGS-based tu­mor pro­fil­ing tests to un­der­go re­view by ac­cred­it­ed third-par­ties is to re­duce the bur­den on test de­vel­op­ers and stream­line the reg­u­la­to­ry as­sess­ment of these types of in­no­v­a­tive prod­ucts,” FDA Com­mis­sion­er Scott Got­tlieb said.

FDA gained the au­thor­i­ty to ac­cred­it third-par­ty re­view­ers un­der the FDA Mod­ern­iza­tion Act to in­crease the ef­fi­cien­cy of re­views for cer­tain de­vices that re­quire a 510(k). The agency cur­rent­ly lists sev­en third-par­ty re­view­ers, in­clud­ing NYS­DOH, that are ac­cred­it­ed to re­view a wide range of Class I and Class II de­vices.

FDA al­so says it has clas­si­fied the IM­PACT test and oth­er NGS-based tu­mor pro­fil­ing tests as Class II de­vices and that lab­o­ra­to­ries that de­vel­op such tests will be able to sub­mit ap­pli­ca­tions to ei­ther FDA or NYS­DOH.

“Mov­ing for­ward, lab­o­ra­to­ries whose NGS-based tu­mor pro­fil­ing tests have been ap­proved by NYS­DOH do not need to sub­mit a sep­a­rate 510(k) ap­pli­ca­tion,” FDA said. Lab­o­ra­to­ries can in­stead for­ward their NYS­DOH ap­pli­ca­tion and the state’s re­view mem­o­ran­dum and rec­om­men­da­tion to FDA to re­ceive 510(k) clear­ance.

FDA re­viewed the IM­PACT test un­der its de no­vo path­way, through which spon­sors can re­quest that the agency clas­si­fy a low- to mod­er­ate-risk de­vice that has no legal­ly mar­ket­ed pred­i­cate de­vice as Class I or Class II.

For its re­view, FDA said it looked at in­for­ma­tion from MSK, in­clud­ing what was sub­mit­ted pre­vi­ous­ly to NYS­DOH “to in­form and ex­pe­dite” its de­ci­sion.

MSK-IM­PACT

The IM­PACT test works by com­par­ing a pa­tient’s tu­mor to a nor­mal tis­sue sam­ple to look for mu­ta­tions in 468 genes and oth­er bio­mark­ers linked to var­i­ous forms of can­cer.

FDA says the IM­PACT test is “high­ly ac­cu­rate” and can iden­ti­fy mu­ta­tions in more genes than any oth­er test it has re­viewed in the past.

How­ev­er, FDA says that while the re­sults of the test can pro­vide valu­able in­sights to pa­tients and physi­cians, its re­sults alone “are not con­clu­sive for choos­ing a cor­re­spond­ing treat­ment.”

As such, the test’s in­di­ca­tions for use state that “the test is in­tend­ed to pro­vide in­for­ma­tion on so­mat­ic mu­ta­tions (point mu­ta­tions and small in­ser­tions and dele­tions) and mi­crosatel­lite in­sta­bil­i­ty for use by qual­i­fied health care pro­fes­sion­als in ac­cor­dance with pro­fes­sion­al guide­lines, and is not con­clu­sive or pre­scrip­tive for la­beled use of any spe­cif­ic ther­a­peu­tic prod­uct.”


First pub­lished here. Reg­u­la­to­ry Fo­cus is the flag­ship on­line pub­li­ca­tion of the Reg­u­la­to­ry Af­fairs Pro­fes­sion­als So­ci­ety (RAPS), the largest glob­al or­ga­ni­za­tion of and for those in­volved with the reg­u­la­tion of health­care and re­lat­ed prod­ucts, in­clud­ing med­ical de­vices, phar­ma­ceu­ti­cals, bi­o­log­ics and nu­tri­tion­al prod­ucts. Email news@raps.org for more in­for­ma­tion.

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A $1B-plus drug stum­bles in­to an­oth­er big PhI­II set­back -- this time flunk­ing fu­til­i­ty test -- as FDA hold re­mains in ef­fect for Ipsen

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UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

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He went on to assure everyone that he hadn’t misrepresented the CRL.

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Sickle cell disease (SCD), which encompasses a group of inherited red blood cell disorders that typically afflict those of African ancestry, impacts hemoglobin — and is characterized by episodes of searing pain as well as organ damage.