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.
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.”
“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
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.
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.