Promoting early cancer detection with at-home test

By Lori Atherton
U-M Law

Kevin Conroy had been at the helm of Exact Sciences Corp. for six months when he learned three friends had been diagnosed with colon cancer.

One of those friends eventually died from the disease, while the other two are in its later stages.

Conroy’s personal connection to colon cancer fortified his resolve to lead Exact Sciences in bringing Cologuard — the first at-home colon cancer screening test — to patients.

In March 2014 the New England Journal of Medicine published a 10,000-patient study of Cologuard that showed it detected 92 percent of colon cancers and 69 percent of the most advanced pre-cancers. These results were quickly followed by the U.S. Food and Drug Administration (FDA) approving Cologuard and the Center for Medicare and Medicaid Services (CMS) announcing a national coverage decision, making the test available to all Medicare patients.

Known as the “most preventable yet least prevented cancer,” colon cancer is the number-two cancer killer of both men and women in the United States, according to the American Cancer Society. Some 50,000 individuals, mostly age 50 or older, die from the disease each year, despite the availability of the colonoscopy and other screening tests.

“Even with significant public awareness about the need for screening, half of people over the age of 50 that are recommended for screening will not get a colonoscopy,” Conroy said, citing embarrassment and the invasiveness of the test as factors. “It is known that by finding early colon cancers and removing those cancers, you significantly increase the likelihood of survival.

Ninety percent of early-stage colon cancer patients survive, but only 10 percent of stage-IV colon cancer patients survive. By detecting early, you completely change the outcome of the patient’s disease.”

Changing the outcome of colon cancer is what Conroy hopes will happen with Cologuard, particularly since it is noninvasive and can be used in the privacy of one’s home. Physicians order Cologuard for their patients from Exact Sciences, which sends a collection kit to the patient’s home.

The patient collects a stool sample and returns the kit to Exact Sciences, where the sample is analyzed for both DNA and hemoglobin markers that could indicate the presence of cancer or pre-cancer in the colon. If the results are positive, the physician will recommend further screening for the patient via a diagnostic colonoscopy; if the results are negative, the doctor will recommend that the patient takes another Cologuard test in three years. Regular reminder phone calls or emails from the customer care specialists at Exact Sciences help to ensure that patients return their collection kits.

When Conroy took over as CEO and president of Exact Sciences in 2009, the company had spent 13 years and more than $300 million trying to develop an effective at-home colon cancer test. Shortly after Conroy joined Exact Sciences, the company entered into a collaborative agreement with the Mayo Clinic and David Ahlquist, MD, to perfect Cologuard, which took another three years.

Anticipating that consecutive patient trials to test the efficacy of Cologuard were required from the FDA and Medicare—a costly 10-year process—Conroy approached Medicare a month into his tenure and asked if it would be possible to conduct one massive clinical trial instead of two trials back-to-back. Medicare and the FDA agreed to create a parallel review process, resulting in Cologuard becoming the first product to undergo FDA and Medicare review simultaneously, Conroy said.

Since Cologuard became available, feedback from both physicians and patients, including those in the Michigan Law community, has been overwhelmingly positive, Conroy noted. One of his friends, for instance, was the 10th person to use Cologuard after it went on the market, and credits the test with saving his life after two advanced pre-colon cancers were detected and removed.

“The ability to have a huge impact on the lives of lots of people is extremely gratifying,” Conroy said. “I truly believe that Cologuard will play a role in increasing colon cancer screening rates, and hopefully will play a role in the eradication of colon cancer.”

A former intellectual property litigator at two Chicago law firms—McDermott Will & Emery and Pattishall, McAuliffe, Newbury, Hilliard, and Geraldson—Conroy originally thought he would pursue a career in medicine after graduating with a BS in electrical engineering from Michigan State University. A summer stint as a hospital orderly, however, helped Conroy realize that direct patient care wasn’t for him. He applied to law school instead, and wound up in the same Michigan Law class as his sister Kelly (Conroy) Kenney, ‘91, and future wife Sheila (Brennan) Conroy, ‘91. After his law firm stints, Conroy became the intellectual property counsel at GE Healthcare. From there, he joined Third Wave (now Hologic), a medical diagnostics product developer, before taking the helm of Exact Sciences.

Conroy said he is grateful for the “analytical rigor” provided by his Michigan Law education, which paved the way for a successful career in both law and business.