Exact Sciences Chairman, President and CEO Kevin Conroy is tackling a problem. His company's Cologuard test is an effective colonoscopy alternative that's being met by criticism from some gastroenterologists.
Mr. Conroy spoke about the test to Forbes, which is profiling him in an upcoming issue:
1. Patients have three choices when it comes to colon cancer screening. Colonoscopy is the gold standard in terms of accuracy, but the $2,200 average price tag is an impediment to some, and the diagnostic colonoscopy loophole shifts the burden from the government to the patient. Fecal immunochemical testing is cheaper at $60, but it must be repeated every year. Cologuard is $649, touts an 8 percent false negative rate and a 13 percent false positive rate and needs to be repeated every three years.
2. Mr. Conroy left the diagnostic company he founded after selling it to Hologic for $580 million. The company had been studying biomarkers since 1995 but didn't create a marketable test. So, what brought Mr. Conroy to Exact Sciences?
The main selling point came from Rochester, Minn.-based Mayo Clinic research David Ahlquist, MD, who argued adding biomarkers to the test panel would dramatically improve Cologuard's sensitivity.
3. Once he signed on, Mr. Conroy began a clinical trial with Exact that led to Cologuard earning both FDA and Medicare approval. Recommendations from the American Cancer Society and Preventive Services Task Force would soon follow.
4. Mr. Conroy said Exact's last hurdle to conquer is the Multi-Society Task Force. The task force gave Cologuard a second-tier recommendation. To earn a first-tier recommendation, the task force wants a long-term study showing Cologuard saves lives. The task force also takes issue with the cost. A fecal immunochemical test every year for three years is cheaper than Cologuard once every three years.
5. Forbes said Cologuard has carved out a market nonetheless, as evident through its $7.3 billion valuation. Forbes spoke with a patient in Milwaukee who avoided getting a colonoscopy for 12 years, until a friend recommended Cologuard. After ordering a kit and forgetting about it for two months, the woman sent in the test and was diagnosed with stage 2 colon cancer. She underwent treatment and is now cancer-free.
6. Speaking about criticism of the test, Dr. Ahlquist said, "As a gastroenterologist, I've been dismayed, reflecting my feelings about how my GI colleagues across the country have responded defensively to the emergence of Cologuard. They've looked at it from the onset as a threat rather than as a tool that their patients can use regularly."
The full story will be available in the Aug. 31 issue of Forbes.
Editor's note: Dr. Ahlquist has a financial interest in Exact, Exact has donated $15,000 since 2016 to the American Cancer Society and Exact has donated more than $30,000 to a group in the Multi-Society Task Force.