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.


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.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

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Belén Garijo, Merck KGaA CEO (Kevin Wolf/AP Images for EMD Serono)

Mer­ck KGaA pumps €440M in­to ex­pand­ing and con­struct­ing Irish man­u­fac­tur­ing fa­cil­i­ties

The area of Ireland famous for Blarney Castle and its cliffsides along the Atlantic Ocean is seeing Merck KGaA expand its commitment there.

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Rep. Katie Porter (D-CA) (Michael Brochstein/Sipa USA/Sipa via AP Images)

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Phillip Gomez, SIGA CEO

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