Biden’s visit highlighted the importance of early detection and improved access to cancer screenings, which are key components of the Cancer Moonshot initiative.
People working in Exact Sciences’ Cologuard® laboratory are used to seeing lab tours, but this one was particularly memorable.
First lady Jill Biden stopped by the Madison, Wis., lab on Aug. 31 to observe the high-tech, multi-step process that tests patient samples for the presence of biomarkers associated with colorectal cancer (CRC).
Biden’s Madison trip emphasized the importance of early detection and improved access to cancer screenings, both of which are key components of the Cancer Moonshot initiative. A Biden administration priority, the moonshot aims to reduce the death rate from cancer by at least 50% percent over the next 25 years and to improve the experience of people who are touched by cancer.
Exact Sciences CEO Kevin Conroy and Chief Laboratory Officer Ana Hooker led Biden on a tour of the 455,000-square-foot Cologuard lab, which skirts the Beltline highway on Madison’s west side. The lab employs hundreds of specimen processors, scientists, lab technicians, and Ph.D.s using state-of-the-art equipment to process CRC screening kits and deliver results for patients.
Cologuard is the first FDA-approved, noninvasive, at-home stool-based CRC screening test for average-risk individuals 45 years or older. It analyzes a person’s stool sample for 10 DNA markers specific to cancer cells, and it also tests for blood present in the stool. The technology detects colorectal cancer earlier — even in precancerous stages — than an ordinary stool-based test.*
Once delivered to the lab by UPS, each person’s kit is opened, registered, and prepared for the DNA extraction process. An automated mixing station, designed by Madison-based Isthmus Engineering, shakes each sample to mix it uniformly. The sample is frozen and then thawed to burst open cells in the sample, making it easier to collect the DNA for analysis. That data feeds an algorithm that determines a result for each patient. Watch the Cologuard lab process.
Accompanying Biden at the lab were U.S. Sen. Tammy Baldwin and Madison Mayor Satya Rhodes-Conway. Kathleen Sebelius, former secretary of the U.S. Department of Health and Human Services, and former Wisconsin Gov. Jim Doyle also joined; both sit on the Exact Sciences board of directors.
More than 10 million people have screened using Cologuard. Exact Sciences is working to further expand access to screenings, including collaborating with Federally Qualified Health Centers, which focus on medically underserved populations, and continuing its Patient Assistance Program, which helps eligible patients facing challenges with insurance coverage receive their Cologuard screening at no cost.†
When caught in early stages, CRC is treatable in about 90% of people.3
“We know that 60 million people are not up to date on their colorectal cancer screening,” Conroy said on the lab tour. “We also know the U.S. has the capacity to do only about 6 million colonoscopies a year.” ‡,4,5,6,7
With Cologuard as a screening option for people of average risk, “what you are seeing here is the future of defeating this disease,” Conroy said.
NOTES AND REFERENCES
*Cologuard performance is based on a large clinical study of more than 10,000 patients ages 50-84 in which Cologuard found more cancers and precancers than an ordinary blood stool Polymedco OC FIT-CHECK test. False positive results can occur and should be discussed with your doctor and followed by a colonoscopy.1,2
†Exact Sciences makes a determination of patient assistance in good faith based on an individualized assessment of financial need.
‡Based on 2022 USA single year census estimates for ages 45-85 inclusive and the percentage of unscreened subjects. Does not account for variable screening rates across age ranges.
1 Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool DNA testing for colorectal-cancer screening. N Engl J Med. 2014;370(14):1287-1297.
2 Wolf AMD, Fontham ETH, Church TR, et al. Colorectal cancer screening for average-risk adults: 2018 guidelines update from the American Cancer Society. CA Cancer J Clin. 2018;68(4):250-281.
3 National Cancer Institute. SEER cancer stat facts: colorectal cancer. Accessed Aug. 30, 2023. https://seer.cancer.gov/statfacts/html/colorect.html
4 United States Census Bureau. Annual Estimates of the Resident Population by Single Year of Age and Sex for the United States: April 1, 2020 to July 1, 2022 (NC-EST2022-AGESEX-RES). Accessed 10May2023. https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html
5 ACS. Colorectal cancer facts and figures 2023-2025. Atlanta: American Cancer Society; 2023.
6 Active physicians with a U.S. doctor of medicine (U.S. MD) degree by specialty, 2015. AAMC. Updated December 2015. Accessed November 14, 2022. https://www.aamc.org/data-reports/workforce/interactive-data/activephysicians-us-doctor-medicine-us-md-degree-specialty-2015.
7 Eberth JM, Josey MJ, Mobley LR, et al. Who performs colonoscopy? Workforce trends over space and time. J Rural Health. 2018;34(2):138-147