| MAYBE YOU DON’T NEED A COLONOSCOPY

Ex­act sciences has a pretty good test for can­cer. Gas­troen­terol­o­gists are un­en­thu­si­as­tic.

Forbes - - CONTENTS - By Michela tin­dera

Ex­act Sciences has a pretty good test for can­cer. Gas­troen­terol­o­gists are un­en­thu­si­as­tic.

Three years ago Kevin Con­roy was stand­ing on Ire­land’s Cliffs of Mo­her, gaz­ing at the At­lantic Ocean 500 feet be­low, when he was blind­sided by a phone call about his com­pany’s colon can­cer test.

Since 2009 Con­roy has been run­ning Ex­act Sciences, a firm try­ing to sell a non­in­va­sive would-be al­ter­na­tive to a colonoscopy. The caller in­formed him that the in­flu­en­tial U.S. Pre­ven­tive Ser­vices Task Force had de­clined to rec­om­mend the Ex­act test as a can­cer-screen­ing tool, which meant it would not be cov­ered by health plans un­der the Af­ford­able Care Act. “Our stock took a mas­sive hit,” says Con­roy, 52. “It was sur­pris­ing. In many ways en­er­giz­ing, though.”

En­er­gized, Con­roy sent in more data. In 2016 the task force gave the Ex­act test a green light. Ex­act’s share price is now more than triple what it was be- fore the task force brush-off.

There are three main ways to de­tect colon can­cer. A colonoscopy is ac­cu­rate but ex­pen­sive ($2,200 on av­er­age). A fe­cal im­muno­chem­i­cal test, which looks for hid­den blood in a stool sam­ple, costs about $60 but is more likely to miss can­cer and must be taken ev­ery year. Then there is Ex­act’s Co­lo­guard for $649.

Like the im­muno­chem­i­cal test, Co­lo­guard uses a stool sam­ple col­lected by the pa­tient and checks for he­mo­glo­bin. It also looks for an as­sort­ment of aber­rant DNA se­quences that are likely to oc­cur in can­cer­ous and pre­can­cer­ous cells. Re­sult: high enough sen­si­tiv­ity that pa­tients can take the test only once ev­ery three years.

Co­lo­guard’s false-neg­a­tive rate is 8% and its false­pos­i­tive rate is 13%. Back-of-the-en­ve­lope math: Among 100,000 peo­ple who take the test once, 90 might have col­orec­tal can­cer, and Co­lo­guard will catch all but 7 of those cases. It will also send 13,000 healthy peo­ple off with wor­ries and in­struc­tions to follow up with a colonoscopy. But then Co­lo­guard has spared 87,000 cus­tomers the un­pleas­ant­ness of a colonoscopy prep day.

Catch­ing colon can­cer early mat­ters. The fiveyear sur­vival rate for pa­tients di­ag­nosed at stage 1 is 92%, but for stage 4 that drops to just 11%, ac­cord­ing to the Na­tional Can­cer In­sti­tute. Col­orec­tal can­cer kills more than 50,000 Amer­i­cans a year. And still only about 65% of those who should get screened for

colon can­cer do. Maybe Co­lo­guard can change that.

Con­roy was ap­proached about the Ex­act Sciences job in 2009 af­ter he sold his pre­vi­ous di­ag­nos­tics com­pany, Third Wave Tech­nolo­gies, to Ho­logic for $580 mil­lion. Ex­act had “no prod­uct, no mean­ing­ful in­tel­lec­tual prop­erty and no sci­en­tist,” he says. The com­pany had been study­ing DNA mark­ers since 1995 but didn’t have a mar­ketable test.

Two things per­suaded Con­roy to sign up. One was that the com­pany would move from Marl­bor­ough, Mas­sachusetts, to Madi­son, Wis­con­sin, where he lives. The other was a com­pelling ar­gu­ment from a Mayo Clinic re­searcher, Dr. David Ah­lquist, that adding dif­fer­ent DNA mark­ers to the test panel could dra­mat­i­cally im­prove Co­lo­guard’s sen­si­tiv­ity. Ah­lquist has a fi­nan­cial in­ter­est in Ex­act.

Con­roy hatched an un­prece­dented plan. Un­til then, com­pa­nies had done one clin­i­cal trial to get ap­proval from the Food & Drug Ad­min­is­tra­tion and a sec­ond to con­vince the Cen­ters for Medi­care & Med­i­caid Ser­vices to pay for the test. This would have been so ex­pen­sive and time-con­sum­ing, Con­roy says, that Ex­act would have gone out of busi­ness. So he per­suaded the bureau­crats to let Ex­act do one.

The trial, us­ing sam­ples from 10,000 pa­tients, was enough to get FDA and then Medi­care ap­proval in 2014. The Amer­i­can Can­cer So­ci­ety rec­om­mended the test shortly there­after, and the nod from the Pre­ven­tive Ser­vices Task Force fol­lowed in 2016. (Ex­act has do­nated $15,000 since 2016 to the Amer­i­can Can­cer So­ci­ety.)

But there is yet one more gaunt­let for Ex­act to run: the Multi-So­ci­ety Task Force, which rep­re­sents gas­troen­terol­o­gists. (Ex­act has do­nated over $30,000 to a group in­volved in the task force.) That panel gives Co­lo­guard a “tier 2” rec­om­men­da­tion, com­pared with “tier 1” for the im­muno­chem­i­cal test and the colonoscopy. The group wants long-term stud­ies that show Co­lo­guard saves lives. It also says a Co­lo­guard test ev­ery three years costs more than the cheaper stool test ev­ery year.

That may be so, but in fact many peo­ple go di­rectly to colono­scopies with­out any pre­screen­ing via stool sam­ples, and that’s a very ex­pen­sive way to pre­vent can­cer deaths.

Plenty of oth­ers get no test­ing. Su­san Pick­er­ing of Mil­wau­kee avoided hav­ing a colonoscopy for 12 years un­til she was fi­nally per­suaded by a friend, at age 62, to use the Co­lo­guard kit her doc­tor had pre­scribed. Af­ter months of let­ting it sit around her house, she ended up test­ing pos­i­tive and was di­ag­nosed with stage 2 colon can­cer in 2017. Af­ter surgery and chemo­ther­apy, she has no de­tectable can­cer.

Says Mayo’s Ah­lquist: “As a gas­troen­terol­o­gist I’ve been dis­mayed, re­flect­ing my feel­ing about how my GI col­leagues across the coun­try have re­sponded de­fen­sively to the emer­gence of Co­lo­guard. They’ve looked at it from the on­set as a threat rather than as a tool that their pa­tients can use reg­u­larly.”

There’s also an in­surance prob­lem. Be­cause the Af­ford­able Care Act man­dates cov­er­age of colon can­cer screen­ing, 85% of pa­tients have no out-of-pocket cost for Co­lo­guard. But those who test pos­i­tive then need a colonoscopy. And this sec­ond, more ex­pen­sive pro­ce­dure is not cov­ered by some plans. With big mar­ket­ing ex­penses (it re­cently hired singer Harry Con­nick Jr. as a spokesper­son), Ex­act lost $39 mil­lion on rev­enue of $90 mil­lion in the first quar­ter of 2018. Still, its $7.3 bil­lion mar­ket value means there are a lot of believ­ers in both Co­lo­guard and what­ever comes next.

Con­roy aims to use his $1 bil­lion cash pile to try to de­velop a blood test to de­tect dis­eases like lung can­cer and liver can­cer. Ex­act has com­pe­ti­tion from well-funded star­tups like Grail and Guardant Health. “This is trans­for­ma­tional. If you can do it, you must do it,” says Ah­lquist. “There’s enough con­ver­gence of tech­nol­ogy now where this is re­al­iz­able. Is it go­ing to be easy? Ab­so­lutely not. It’s go­ing to be hard, but we can get through this.”

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