Colorectal cancer is a major killer in the United States. It is the third most diagnosed cancer and the second leading cause of cancer-related deaths in the country. The National Cancer Institute estimates that about 135,000 new cases of colorectal cancer will occur in the U.S. this year, with a 65.1% five-year survival rate.
Colorectal cancer occurs in the colon, a portion of the large intestine. This type of cancer usually begins as a polyp, or an abnormal growth inside the colon. These polyps may become cancerous, so it’s important that they are detected and removed at early stages.
Colorectal cancer is highly preventable if detected at the pre-cancerous polyp stage. So then why is it so lethal? The problem lies in the people. Colorectal screening participation rates in the U.S. are very low. The gold standard screening technique for this cancer is the colonoscopy.
No one wants a colonoscopy.
During a colonoscopy, a physician visually looks for the presence of polyps inside the colon by inserting a small camera, via a long tube, right up the rectum. If polyps are detected, a biopsy can be done to determine if the growths are cancerous. The colon must be completely emptied to prepare for a colonoscopy, which requires a specialized diet and sometimes laxatives and enemas.
So, obviously, colonoscopies are fairly invasive, hence the large screening non-compliance issue. They also are an operator-dependent procedure and sometimes force people to take off multiple days of work.
A team at the Mayo Clinic and the Madison-based diagnostic company Exact Sciences developed an alternative colorectal cancer screening method to the colonoscopy. Their product, Cologuard, is a non-invasive diagnostic test that examines eleven different colorectal cancer biomarkers in, you guessed it, poop.
The test can be done in the privacy of your home with no special prep required. You just need to produce some stool into a sealable container and then ship it off via UPS. Lovely.
The Cologuard test is based on a phenomenon called cell shedding. Colon cancers and polyps have this mucocellular layer that sits overtop of the cancer cells and sheds cells into the large intestine, eventually ending up in the stool. Advanced technology is used to test DNA within these shed cells in the stool and detect any abnormalities associated with cancer development.
Cologuard was approved by the FDA in 2014 and is now commercially available. The test has similar sensitivity to the colonoscopy to detect early stage cancers, minus the whole invasive and uncomfortable procedure. Cologuard has even increased colorectal screening compliance. In the first 100,000 patients who tested Cologuard, 42% reported no prior screening.
Dr. David Ahlquist, a gastroenterologist at the Mayo Clinic, and Kevin Conroy, CEO at Exact Sciences, spoke about their unique collaboration to create Cologuard during the Mayo Transform Conference last week.
Here are three major lessons learned by the hybrid Mayo Clinic/Exact Sciences team for what it takes to move disruptive medical technology onto the market.
1. Collaborate to solve really big problems.
The mission of Cologuard is to “eradicate colon cancer”. That’s one pretty lofty goal. If you want to change the world, you better be working with the best. In this partnership, the Mayo Clinic had the colorectal cancer expertise; the clinic ranked as the best Gastroenterology and GI Surgery hospital in 2016 in the U.S. News & World Report. Exact Sciences had the ability to produce and sell the tests. They built a lab that could manufacture one million Cologuard tests a year.
2. You’ll need lots of patience and persistence.
The team needed $400M to take Cologuard from a concept to a commercial product. They spent three years developing a prototype, during what they call the “molasses phase”. The product needed to be FDA approved. It also needed to be covered by Medicare because; the team did not have the funds to take Cologuard to clinical trial if someone could not pay for it at the back end. Cologuard ended up being the first product in U.S. history to be jointly reviewed by the FDA and the Centers for Medicare and Medicaid Services. In the end, Cologuard gained both approval and a viable financing model, at least for some patients.
3. It takes some thick skin.
When Cologuard was first FDA approved, the team paid for a front page ad in the New York Times to start some chatter around the product. That gained them over 1,000 articles about the product in its first ninety days.
However, it has been extremely difficult to get Cologuard included in key cancer screening guidelines. Gaining acceptance of a technology that runs against a standard medical practice, the colonoscopy, can be like trying to move a mountain. Some are only updated every eight to ten years, plenty of time for a company to go out of business.
Cologuard was approved by the FDA in 2014, but it was only included in The American Cancer Society’s screening guidelines in that year. It took until 2016 for Cologuard to finally be added to the United States Preventative Services Task Force cancer recommendations. The test will also be included in the 2017 Healthcare Effectiveness Data and Information Set as a quality measure for colorectal cancer screening.
Cologuard received Medicare coverage in its early stages, which takes care of about 50% of potential users. Commercial insurers, the other half of the equation, will currently only cover an additional 30%.
Cologuard is starting to gain acceptance, but this diagnostic test has a long way to go.