January is a time to reflect on the past year, and the year ahead. This week, I’ll be doing just that when I present at the 35th Annual J.P. Morgan Healthcare Conference. I’ll be reflecting on some big news: In 2016, Exact Sciences completed 244,000 Cologuard tests.
What is the impact of completing 244,000 tests? If we compare that number to the data from our pivotal study1 published in the New England Journal of Medicine, we estimate that in 2016, more than 1,100 early-stage cancers were present in individuals who tested positive with Cologuard. Catching colon cancer early is key—when it is caught in its earliest stages the five-year survival rate is greater than 90%.2
Let’s look at what completing 244,000 Cologuard tests means for real people. Around this time last year, Dorothy reached out to us and shared her story. The Boston-area runner had recently turned 50 and screened with Cologuard. After receiving a positive result and her diagnostic colonoscopy, she discovered that she had Stage I colon cancer. After having her cancer removed, Dorothy is now cancer free, and looking forward to crossing more finish lines in 2017.
Our chief medical officer Dr. Barry Berger and I had the pleasure of meeting Dorothy last summer at an investor conference. When we introduced her and her story to the audience, it brought them to their feet. That’s the power of early detection. Dorothy and the thousands of others like her serve as our inspiration to get more people screened in 2017 and beyond. It’s not about numbers, it’s about people.
- Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1987-97.
- American Cancer Society, Cancer Facts & Figures 2016 http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-047079.pdf.
Cologuard was approved by the FDA in August 2014 and results from Exact Sciences' prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the recommendations of the U.S. Preventive Services Task Force (2016) and the American Cancer Society's (2014) colorectal cancer screening guidelines. Stool DNA is included in the combined screening guidelines of the American Cancer Society / U.S. Multi-Society Task Force/American College of Radiology (2008), the American College of Gastroenterology guidelines (2009) and the National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.CologuardTest.com . Rx Only.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the early detection and prevention of the deadliest forms of cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening technology for the detection of colorectal cancer. For more information, please visit the company's website at www.exactsciences.com , follow Exact Sciences on Twitter @ExactSciences or find Exact Sciences on Facebook.