Exact Sciences’ Cologuard cancer test debuts

Aug. 31--Exact Sciences' spanking clean, new labs in the Novation Campus, off Rimrock Road, sit waiting for the rush to begin.

Their mission: to examine stool samples from patients for DNA markers that could signal colorectal cancer.

Cologuard, Exact Sciences' new test for the cancer -- requiring little more from patients than simply having a bowel movement -- will revolutionize the testing process, experts say, by offering a viable alternative to colonoscopy.

That means millions of containers of human feces could come through the company's doors for analysis -- maybe as many as 10 million a year, or more. Two federal agencies OK'd the test on Aug. 11, the first simultaneous approval of a product by the Food & Drug Administration and by the Centers for Medicare & Medicaid Services.

"It's so gratifying, to work with something a long time, something so important, and have it all work out better than expected," Exact Sciences chief executive Kevin Conroy said.

One-hundred-twenty sales representatives have been trained and positioned around the U.S., telling physicians how Cologuard works and urging them to try it for patients who may shudder at the thought of a colonoscopy. A call center at the new lab building is open 24 hours a day to take orders from physicians and questions from the public.

With more than 145,000 new cases and 50,000 deaths from colorectal cancer expected this year, according to the National Cancer Institute, there is no time to lose, Conroy said.

Mayo Clinic, of Rochester, Minnesota, announced last week it will be the first health system in the U.S. to offer Cologuard. The new screening technology will be a "game changer" that will "revolutionize" the system by getting more people tested earlier, said Dr. Vijay Shah, Mayo's chairman of gastroenterology and hepatology.

"It will, therefore, save lives," Shah said.

Mayo Clinic collaborated with Exact Sciences to develop the test and to enroll patients in a massive clinical trial that checked more than 10,000 people at 90 sites in the U.S. and Canada. It found Cologuard correctly identified colorectal cancer in 92 percent of the cases. Studies have shown colonoscopy detects cancer in 92 to 95 percent of cases.

In Madison, Group Health Cooperative of South Central Wisconsin, said it will be the first in Wisconsin to offer the new screening tool to its patients.

"We've been in discussion with Kevin Conroy and his team at Exact Sciences for months with our medical leadership closely reviewing this innovative option during the development phase," said Kevin Hayden, CEO. "GHC-SCW will be integrating it into appropriate preventive testing for our members in the weeks and months ahead."

So far, it is the only HMO in Madison to do so. Unity Health Plan, Dean Health Plan, Physicians Plus and WPS Insurance said the test and its supporting evidence will be reviewed.

"At this time, Cologuard is considered experimental as long-term data and efficacy have not been available to review, particularly its effectiveness compared with the current standards of care for colon screening," Unity Health spokeswoman Jennifer Dinehart said.

Exact will work with insurers on the patient's behalf, Conroy said. "We collect $50 from patients and bill the insurer (for the rest). If it doesn't pay, we will file an appeal and keep appealing," he said.

For Madison, and the state as a whole, creation of this new technology is both a health benefit and an economic boon.

Exact Sciences has 300 employees, about 200 of them in Madison. That's up from 80 in September 2012.

With the U.S. on board, Exact is expected to seek approval for Cologuard overseas. And Cologuard could be the first of a series of screening tests Exact will develop with the Mayo Clinic for other GI tract ailments.

"We think Cologuard is just the start of our mutual innovative power," Conroy told the news conference.

Cologuard easier

than colonoscopy

For many people, a colonoscopy, recommended for those age 50 and over, is a thing to dread.

Preparation starts the day before when the patient, already on a liquid diet, has to drink one gallon of a potion that clears out the colon by triggering diarrhea. For the procedure itself, the patient is under sedation as a thin, flexible tube with a tiny camera attached is snaked up the rectum and large intestine to look for polyps, tumors, inflammation or other problems.

The American Cancer Society says one in three Americans, ages 50 to 75, are not getting screened as recommended, even though the five-year survival rate for early-stage cancer can be more than 90 percent.

With Cologuard, no medical device is inserted into the body and nothing special has to be gulped down.

The test must be ordered by a physician; it's not something the public can buy off a drug store shelf.

Here's how the process works: When a doctor prescribes Cologuard, a small cardboard box is sent to the patient's home. It contains a plastic bracket that is placed over the toilet seat and a wide-mouthed plastic jar, or "collection device," that fits in the middle.

"And then the magic moment comes and the patient provides a sample," Conroy said.

The patient dabs the sample with a probe and a small amount of stool is put into a mascara tube-size plastic vial. A liquid preservative is poured over the rest of the sample, and the wide-mouthed jar and the vial go back in the box for shipment to Exact Sciences.

Conroy said he's tried the process. "It's easy. I'd rather do this than follow my dog around the yard," he said.

Two local sites

Exact Sciences handles Cologuard coming and going, at its two locations.

Company headquarters, 441 Charmany Drive, in University Research Park, is where the components are assembled into boxed kits. Most of the components are made by other companies. One enzyme comes from Promega Corp., Fitchburg; another, Cleavase, was developed by Third Wave Technologies, a former Madison company acquired by Hologic, of Bedford, Massachusetts, in 2008. Conroy was CEO of Third Wave at the time.

The new labs, at 145 E. Badger Road in the town of Madison, analyze the samples and record the results. The 30,000-square-foot space was remodeled in a four-month, $12 million project in late 2013.

Conroy said when a test kit arrives, the large collection jar is shaken and one test tube worth of the mixture is poured out and frozen overnight. The next day, some of the contents are removed and clarified so the DNA can be extracted -- specific genes are considered biomarkers for possible colorectal cancer. Magnetic particles "literally grab the four genes that you want to test," Conroy said.

The smaller sample is checked for blood in the stool, which also can signal problems including cancer. Results are sent to physicians within two weeks. If the test reads positive, the patient is asked to have a colonoscopy.

Optimistic reviews

Several analysts with financial firms that monitor publicly traded Exact Sciences are giving Cologuard -- and the company's future -- optimistic reviews.

"There's clearly many avenues for future growth here; (Exact is) really just getting started," said Jeffrey Elliott, of Robert W. Baird & Co.

Exact's labs can handle 1 million tests a year, and there are 80 million Americans over age 50, Conroy said. He speculated 8 million to 10 million Americans a year could use Cologuard.

"We would have to grow our workforce significantly to be able to meet that demand," said Conroy, who will turn 49 on Sept. 1. "We would rather grow here in Wisconsin than any place else."

Exact is seeking approval from the European Union and could begin marketing Cologuard in countries such as Germany in the first quarter of 2015, analyst Brandon Couillard, of Jefferies & Co., wrote in a July 23 note.

Use of Cologuard overseas could surpass even the U.S. market, Baird's Elliott said, especially in rural areas that may lack doctors who perform colonoscopies.

Conroy has said Exact is working on additional tests to diagnose cancers of the pancreas, stomach and esophagus, ulcerative colitis and Crohn's disease.

Cologuard itself shows "50 percent sensitivity" to esophageal cancer and Exact's "pancreatic development indicates 88 percent cancer detection," Canaccord Genuity analyst Mark Massaro wrote on Aug. 26.

Conroy's mission now is to get the word out about Cologuard. The company placed a full-page ad in The New York Times on Aug. 17 that said: "Introducing Cologuard ... the new noninvasive test that's ready when you are."

And Madison'sExact Sciences is ready for them all.

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