A screen­ing for colon cancer you can do at home? Sign me up

Mil­lions of Co­lo­guard kits ar­rive at Ex­act Sciences of Madison, Wis­con­sin. I watched what hap­pens to them.

Chicago Sun-Times - - FRONT PAGE - NEIL STEIN­BERG,

The best way to treat cancer is to find it early. So when I turned 60 in June, I went for a check-up. COVID-19 might have kept me away. But I had made the ap­point­ment be­fore the pan­demic started, and by then the cri­sis had di­aled back a notch. I didn’t want to can­cel, so masked up and went in to get poked and prod­ded.

Ev­ery­thing seemed ship­shape: heart beat­ing, lungs re­ceiv­ing air. My doc­tor scanned his lap­top: 10 years since my last colonoscop­y — a probe with a tiny cam­era, check­ing out the in­testines for can­cer­ous polyps. Time for an­other.

I gri­maced and echoed the clas­sic tod­dler com­plaint, “Do I hafta?” think­ing of guz­zling a gal­lon of Mi­raLAX, used to clean out the plumb­ing the evening be­fore the pro­ce­dure. Not fun.

No, the doc­tor said, now there is a home test ...

Great, I said, hop­ping up, let’s do that. Never con­sid­er­ing what a home test meant. For­get­ting all about it, in fact, un­til a cube­shaped box showed up, a Co­lo­guard kit from Ex­act Sciences Lab­o­ra­to­ries of Madison, Wis­con­sin.

Here it is prob­a­bly best not to go into too much graphic de­tail, though that is com­ing. You might want to set this aside un­til af­ter break­fast.

In the kit: is a plas­tic bracket to be placed over the toi­let; a stout white jar, or “sam­ple con­tainer,” that sits in the cen­ter of the bracket and is aimed for; and a lit­tle vial with a wand in it — rather like mas­cara — that is later dipped into the con­tents of the jar. The wand is there be­cause Co­lo­guard tests for two things: both DNA re­veal­ing early cancer, and the blood that can be a sign of late-stage can­cers.

Fill­ing the jar is ... not a pleas­ant process. A cer­tain blank de­ter­mi­na­tion is re­quired — emp­ty­ing your mind and fol­low­ing in­struc­tions. When I was at Step 5(f ) “Turn the lid to tighten un­til it does not tighten any­more,” I had a thought, and that thought was, “Who is go­ing to open this jar?”

“I see it as a ser­vice to hu­man­ity,’ said Huan Hoang, who es­caped from Viet­nam in April 1975. He joined Ex­act Sciences last year af­ter a ca­reer as a phar­ma­cist, and now is a Spec­i­men Pro­cess­ing As­so­ciate, Level 2 in Madison. Hoang opens the jars. “This is se­ri­ous busi­ness we’re do­ing,” he says. “I’m in the busi­ness of tak­ing care of peo­ple.”

Four mil­lion boxes have ar­rived since the FDA ap­proved the process in 2014. The Madison lab started out as a sin­gle suite and, ex­pand­ing 11 times, now fills a med­i­cal build­ing, run­ning three shifts, 24 hours a day, seven days a week, with three other build­ings in the city, in­clud­ing a new cor­po­rate head­quar­ters.

“It starts with the Co­lo­guard kits com­ing in, be­ing cooled down,” Hoang ex­plained.

Chill­ing the boxes sta­bi­lizes the sam­ples. One by one, the boxes are placed on a large ma­chine.

“Get­ting the kits into the box cut­ter,” Hoang said.

If “box cut­ter” makes you think of a ra­zor in a plas­tic han­dle, think again. Each box is set onto a con­veyor, then four alu­minum brack­ets shoot in, brac­ing the box pre­cisely at each cor­ner. A ro­botic arm makes three neat cuts. Af­ter ev­ery cut, the arm tucks the blade briefly un­der a laser, to check its sharp­ness as the box goes on its way.

In a colonoscop­y, a doc­tor checks for cancer, vis­ually. With Co­lo­guard, your own ex­cre­ment acts as a swab; as it worms through your in­testines.

“It’s very sim­ple,” said Ex­act Sciences chair­man and CEO Kevin Con­roy, who in 10 years took Co­lo­guard from an un­proven con­cept to a com­pany with 4,000 em­ploy­ees. “If you have cancer, or even a precancero­us polyp, those cells shed and end up in your stool. What we do is look for tiny changes that oc­cur inside those cells.”

This process, which takes days, dis­tills the con­tents of that jar, a stool the size of a candy bar, and con­denses it into half a teardrop’s worth of DNA that will be tested. Many ma­chines are in­volved.

The sec­ond test, that lit­tle mas­cara-shaped tube, is a he­mo­glo­bin test. Be­fore the jar is sealed, the pa­tient jabs the swab into the, umm, sam­ple, then pours a con­tainer of preser­va­tive into the rest.

“Cau­tion: Do not drink the liq­uid” warn the in­struc­tions, giv­ing an idea of the chal­lenge of walk­ing ev­ery con­ceiv­able per­son at ev­ery stage and con­di­tion of life through the process. The in­struc­tion book­let is 27 pages.

“Most peo­ple look at the pic­tures,” said Kris Bisch, se­nior man­ager of clin­i­cal labs at Ex­act Sciences. “They don’t read at all. So we try to make the in­struc­tions crys­tal clear.”

They are. The in­struc­tions do not, how­ever, say “Don’t drop your wed­ding ring in the jar.” That has hap­pened. Eye­glasses too.

“We find all sorts of things,” said Bisch.

Such as cash tips — I am not the only per­son won­der­ing about who opens the jars.

Any­thing of value is re­turned. There is a bul­letin board of what Hoang calls “Love notes” — mes­sages tucked into the boxes Some are jokey.

“Craft made, lo­cally sourced, home grown.”

Some are em­pa­thetic. “You don’t get paid enough money.”

One cus­tomer sent a tree­shaped card­board air fresh­ener, straw­berry scented. Though in truth the lab does not smell at all, thanks to plex­i­glas hoods and an air cir­cu­la­tion sys­tem that com­pletely ex­changes the air in the room six times an hour.

The test­ing process de­fies quick syn­op­sis, but let’s try: The jars are vi­brated on a de­vice like a paint mixer for three min­utes to ho­mog­e­nize the con­tents. Then they are frozen for eight hours — freez­ing breaks down the cell walls of the, ah, ma­te­rial, to help get at the DNA. Af­ter thaw­ing, the jars are taken by a tech­ni­cian who does what might be con­sid­ered the ick­i­est part of the process: ex­tract­ing three 45 cc tubes of brown liq­uid. It is also where skill fac­tors in, de­pend­ing on the ... umm ... con­sis­tency of the sam­ple.

“If a spec­i­men is re­ally foamy, or re­ally thick,” said Brenda Maass, se­nior man­ager spec­i­men pro­cess­ing lab, then the sam­ples have to be drawn off us­ing suc­tion through a tube. But staffers who are “very ex­pe­ri­enced, very brave” can sim­ply pour from the jars into the three cal­i­brated tubes, though that in­creases the risk of some­thing con­stantly guarded against: spillage. Spilling is bad.

Two of the tubes are frozen in case they are needed — some­times ma­chines spoil a batch. De­spite care, tubes are dropped. It’s bet­ter not to have to re­quest a new sam­ple.

The heart of the tests oc­curs in a neg­a­tive pres­sure room con­tain­ing banks of com­pli­cated ma­chin­ery, with names like Thermo Fisher 7500, that use mi­cro­scopic mag­netic iron beads that bond with 10 types of DNA spe­cific to colorec­tal cancer. The DNA is am­pli­fied — copied re­peat­edly — so tags added to it can give off light whose in­ten­sity al­lows Ex­act Sciences to de­ter­mine if cancer is present, and mea­sure to what de­gree.

Af­ter less than a year drawing sam­ples, a job start­ing at $17 an hour, em­ploy­ees can hope to move up.

“We try re­ally hard so some­body with no prior clin­i­cal ex­pe­ri­ence can move up to the next role, ex­cep­tion han­dler, within nine months,” said Maass. The ex­cep­tion han­dler deals with prob­lems

— an empty con­tainer, say, or a pa­tient who has writ­ten the cur­rent year as their birth year.

“We’re go­ing to have to con­tact those pa­tients,” said Maass. “We do ev­ery­thing we can so pa­tients don’t have to re-col­lect.”

Be­ing an Ex­act Sciences phone rep­re­sen­ta­tive can be del­i­cate work.

“We deal with a sen­si­tive topic,” said Rob Baierl, who has han­dled calls for three years. “This is a sen­si­tive time for some pa­tients. We need to be thought­ful.”

For ex­am­ple?

“A pa­tient called in, ask­ing how to do the col­lec­tion kit,” said Baierl. “We had a de­tailed and long con­ver­sa­tion, then he went off topic. The pa­tient ex­pressed opin­ions about var­i­ous per­sonal things. I was try­ing to po­litely end the call . ... I re­al­ized the pa­tient was wait­ing to col­lect the sam­ple dur­ing the call. We were wait­ing for that to hap­pen.” Ul­ti­mately in vain.

Home test­ing will be­come only more im­por­tant in the COVID-19 era. The pan­demic not only has killed nearly 189,000 Amer­i­cans as of La­bor Day, but also has cost thou­sands of ad­di­tional lives of peo­ple who re­sisted en­ter­ing the med­i­cal sys­tem — for in­stance, to get tests. The pub­lic was re­minded of the lethal­ity of colon cancer at the end of Au­gust, with the death at age 43 of “Black Pan­ther” star Chad­wick Bose­man.

The Amer­i­can Cancer So­ci­ety rec­om­mends that all men get screened for colon cancer by age 45. Yet four in 10 Amer­i­cans never do. This prob­lem is es­pe­cially acute for Black men. Be­cause of lower rates of screen­ing, death rates from colon cancer are 43 per­cent higher in African Amer­i­cans than in whites.

None of the Ex­act Sciences work­ers I spoke with were squea­mish about the grosser as­pects of their job. In­stead, they were en­thu­si­as­tic about the 10,000 cancer cases that have been flagged by their Co­lo­guard sys­tem.

“We’re try­ing to change lives with early de­tec­tion,” said Uzoma Iwuagwu, a su­per­vi­sor and im­mi­grant from Nige­ria. “Such a great feel­ing, try­ing to get pa­tients screened. We’re just one big team. I thor­oughly en­joy com­ing to work ev­ery day.”

“IT’S VERY SIM­PLE. IF YOU HAVE CANCER, OR EVEN A PRECANCERO­US POLYP, THOSE CELLS SHED AND END UP IN YOUR STOOL. WHAT WE DO IS LOOK FOR TINY CHANGES THAT OC­CUR INSIDE THOSE CELLS.” KEVIN CON­ROY, Ex­act Sciences chair­man, CEO

PRO­VIDED

An Ex­act Sciences tech­ni­cian looks over cus­tom-built mix­ers that ho­mog­e­nize sam­ples. Se­cur­ing the con­tain­ers so they don’t come loose is im­por­tant.

ABOVE: A tech­ni­cian la­bels tubes at Ex­act Sciences Lab­o­ra­to­ries. With two dozen steps to the test­ing pro­ce­dure over a pe­riod of days, mak­ing sure pa­tient in­for­ma­tion stays with ev­ery sam­ple is a pri­or­ity.

PRO­VIDED

LEFT: A spec­i­men pro­cess­ing as­so­ciate adds an iden­ti­fy­ing la­bel to a sam­ple jar at Ex­act Sciences Lab­o­ra­to­ries in Madison. Keep­ing track of pa­tient in­for­ma­tion is key to the process.

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