You know you’ve made it as a health care diagnostic company when Woody Harrelson spoofs your signature product on Saturday Night Live, which happened during a somewhat bizarre skit in early 2023.
It’s even better when you have 10 years of data to demonstrate your product works.
Both are the case with Madison-based Exact Sciences Corp. and its at-home Cologuard test, which has been used 16 million times since its 2014 approval by the U.S. Food and Drug Administration to screen for colorectal cancer in middle-aged and older adults at average risk for the disease.
The SNL skit, which featured Harrelson being swarmed by a host of talking cardboard Cologuard boxes, was funny — but colorectal cancer is not. It’s the No. 2 cancer-killer, with up to 53,000 Americans projected to die from it this year alone, yet also one of the most preventable and treatable cancers.
In a 10-year span, Cologuard has detected 525,000 people with advanced precancerous lesions — growths or “polyps” that can be removed to prevent cancer. About 42,000 people who used Cologuard were found to have Stage 1 cancer, meaning it was detected early enough for treatments to prevent a dangerous spread. Data from the Centers for Disease Control and Prevention and other sources show that Cologuard is a major reason why significantly more Americans 45 and older are getting tested, a regimen formerly confined to invasive colonoscopies.
Projections also show Cologuard screening is helping to reduce health-care costs by reducing scheduling, nursing, and other provider hours, leaving medical professionals more time to focus on people with serious symptoms.
Now there’s a new “box” on the block, called Shield, which is a blood test produced by Guardant Health of Palo Alto, California. Recently approved by the FDA for people in the same age group, the blood sample can be obtained at a doctor’s office as part of a routine physical examination, or at a commercial laboratory.
It could be another way to reach people who might resist mailing samples of their feces to a lab for testing (the Cologuard approach), but data reviewed by the FDA indicates Shield isn’t as effective in finding the very earliest cancers and especially precancerous polyps.
Dr. David Lieberman, chairman of the colorectal cancer workshop within the American Gastroenterology Association, wrote in March: “Based on their current characteristics, blood tests should not be recommended to replace established colorectal screening tests, since blood tests are neither as effective or cost-effective, and would worsen outcomes.”
An expert at Exact Sciences was more nuanced.
“Many more people need to get screened,” said Dr. Paul Limburg, chief medical officer for Exact Sciences. “Innovation is a good thing. Offering informed choice is a good thing … blood tests are certainly better than nothing.”
Cologuard’s edge is that it can find precancerous polyps on the lining of the colon by detecting fragments of DNA that are shed by such polyps. Data indicates Cologuard is three times better at finding those cell fragments, which are precursors to tissue breakouts by cancer cells.
Dr. Limburg said that while some people may see Shield or similar blood tests as an “easy option” for screening, there’s a “big risk” it will intensify cancer detection disparities in the population. For example, studies show that Black Americans are about 20% more likely to get colorectal cancer than other groups, and 40% more likely to die from it.
With or without competition, Exact Sciences is not willing to stand pat. The company is working on an updated version of Cologuard that promises to be more effective with several multidetect tests. These can pinpoint tumor-specific DNA that remains in the body after cancer treatment, or may lead to early detection for liver, kidney, and ovarian cancers. The company has about 6,500 employees, mostly in Madison — where it relocated in 2009 — and around the world.
At 10 years old, that friendly, talking Cologuard box makes for more than a funny SNL skit: It contains the diagnostic power to help many more people avoid colorectal cancer or to treat it earlier.
