Us­ing ge­nomics to pair pa­tients with best breast can­cer treat­ments

Modern Healthcare - - INNOVATIONS - By Erica Te­ichert

Breast can­cer is one of the most preva­lent can­cers in the U.S., and it’s also one of the most treat­able. But those treat­ments of­ten come with tough side ef­fects.

Pa­tients typ­i­cally have chemo­ther­apy, surgery, ra­di­a­tion or a mix­ture of those treat­ment op­tions to erad­i­cate or shrink the can­cer.

Irvine, Calif.-based Agen­dia has de­vel­oped a test the com­pany says makes it eas­ier for physi­cians to de­ter­mine if chemo­ther­apy is nec­es­sary, spar­ing many pa­tients from the toxic ef­fects of the drugs, which can in­clude pre­vent­ing young women from hav­ing chil­dren af­ter treat­ment.

Agen­dia’s Mam­maPrint uses a 70-gene as­say to de­ter­mine whether a woman has high- or low-risk breast can­cer rather than us­ing a stan­dard clin­i­cal risk anal­y­sis that re­lies on tu­mor grade and other fac­tors. If Mam­maPrint shows a pa­tient has high-risk breast can­cer, it’s rec­om­mended they re­ceive chemo­ther­apy treat­ment. Low-risk pa­tients can forgo chemo­ther­apy and have a sim­i­lar five-year sur­vival rate, ac­cord­ing to re­search.

Re­cent re­sults from Agen­dia’s 6,700pa­tient study called Min­dact, pub­lished in Au­gust by the New Eng­land Jour­nal of Medicine, found that 46% of pa­tients con­sid­ered to be at high risk of breast can­cer re­cur­rence based on clin­i­cal-patho­log­i­cal fea­tures can pass on chemo­ther­apy and are ac­tu­ally low risk ac­cord­ing to the test.

Agen­dia ex­pects to re­ceive more re­sults from Min­dact later this year, which could lead to more cen­ters us­ing the study and bet­ter re­im­burse­ment agree­ments with in­sur­ers. Early re­sults from the study have cor­rob­o­rated that Mam­maPrint can iden­tify which pa­tients should or shouldn’t re­ceive chemo­ther­apy treat­ment, and they will have sim­i­lar five-year sur­vival rates.

The stud­ies have also shown Mam­maPrint de­tected some high-risk pa­tients that should have re­ceived chemo­ther­apy but didn’t be­cause of their can­cer’s clin­i­cal pre­sen­ta­tion.

Agen­dia was founded in 2003 as a spinoff from the Nether­lands Can­cer In­sti­tute, and it still has connections there. The com­pany has two CMS-cer­ti­fied lab­o­ra­to­ries for an­a­lyz­ing breast can­cer spec­i­mens—one in Am­s­ter­dam and one in Irvine, Calif.—and they re­ceive sam­ples from around the globe.

An­a­lyz­ing pa­tient spec­i­mens takes four days. The com­pany con­firms the tu­mor di­ag­no­sis be­fore mi­cro-dis­sect­ing the tu­mor sam­ple and ap­ply­ing the ge­nomic test. The re­sults are then sent to physi­cians via the cloud, help­ing them make real-time de­ci­sions about a pa­tient’s ther­apy op­tions.

While there are other ge­netic tests that cal­cu­late whether a pa­tient’s breast can­cer is high-risk or low-risk, Mam­maPrint is the only one cleared by the U.S. Food and Drug Ad­min­is­tra­tion.

“We just think it’s the right thing to do to make sure our pack­age, our process, ev­ery­thing is up to snuff in terms of qual­ity and com­pli­ance,” Agen­dia CEO Mark Sta­ley said. “We be­lieve it sets the new stan­dard, the new bar by which any cov­er­age de­ci­sions need to stack up.”

Dr. Peter Blu­men­cranz, med­i­cal direc­tor of the Com­pre­hen­sive Breast Pro­gram and Can­cer Ser­vices at Mor­ton Plant Mease Health Care in Clear­wa­ter, Fla., said he be­lieved Agen­dia’s science was bet­ter than its com­peti­tors at guid­ing clin­i­cians to the best course of treat­ment for each pa­tient. “That is the point—one size doesn’t fit all,” Blu­men­cranz said. “It’s a mat­ter of what surgery is ap­pro­pri­ate, what med­i­ca­tion is ap­pro­pri­ate.”

Blu­men­cranz’s cen­ter treats ap­prox­i­mately 500 breast can­cer pa­tients ev­ery year. While the cen­ter doesn’t or­der Mam­maPrint for ev­ery pa­tient, Blu­men­cranz says that Mam­maPrint and an­other Agen­dia test—Blue­Print—help physi­cians make per­son­al­ized care de­ci­sions.

Blue­Print is an 80-gene as­say Agen­dia has de­vel­oped to help guide hor­monal ther­apy de­ci­sions be­fore pa­tients even get to chemo­ther­apy treat­ments. Ac­cord­ing to Sta­ley, if the right hor­monal ther­apy is se­lected, it could eliminate the need for chemo­ther­apy later on.

The com­pany also is work­ing with sev­eral phar­ma­ceu­ti­cal com­pa­nies on clin­i­cal tri­als that pair Mam­maPrint as a com­pan­ion di­ag­nos­tic to breast can­cer drugs. “It’s a grow­ing and bur­geon­ing piece of our busi­ness as well and will al­low us to ex­pand broadly and de­liver on the prom­ise of re­ally help­ing de­liver on this per­son­al­ized medicine one pa­tient at a time,” Sta­ley said.

A Mam­maPrint mi­croar­ray of two tu­mor biop­sies: low risk, top, and high risk, bot­tom. Ac­tive genes, in­clud­ing many that help tu­mors grow and spread, show up red, and in­ac­tive ones green.

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