Exact Sciences Corp. presented new data at the American College of Gastroenterology (ACG) Annual Meeting, focusing on the Cologuard Plus test and strategies to improve colorectal cancer (CRC) screening adherence. The data included modeling that assessed the benefit-to-burden ratio of various CRC screening strategies and real-world evidence on enhancing patient adherence, particularly in underserved communities.
Cologuard Plus: Balancing Benefit and Burden
Modeling data presented at ACG indicated that the Cologuard Plus test offers the best balance between life-years gained and the number of colonoscopies required among non-invasive CRC screening options. Researchers used a validated simulation model to evaluate the Cologuard Plus test against other established and emerging CRC screening methods. The study defined benefit as life-years gained and burden as the lifetime number of colonoscopies.
Specifically, the next-generation mt-sDNA test was the only efficient non-invasive modality for screening over the guideline-recommended age interval of 45-75 years. Blood-based screening strategies were not efficient or near-efficient at any screening interval or age-range.
Paul Limburg, MD, MPH, AGAF, chief medical officer for Screening, Exact Sciences, stated, "Exact Sciences is pleased to share new modeling data which demonstrates the Cologuard Plus test as an efficient CRC screening strategy across modeled age ranges and screening intervals, given its high sensitivity and specificity for both cancer and precancer."
Enhancing Adherence to CRC Screening
Seven abstracts presented at the meeting highlighted patient-centric research on improving CRC screening adherence rates, particularly in underserved populations. These strategies, which include patient navigation and personalized outreach, have the potential to significantly impact millions of lives. Modeling suggests that widespread implementation of these strategies could reduce the CRC screening gap by as much as 10%.
One study demonstrated high adherence rates to mt-sDNA testing across a large, national sample of insured individuals between ages 45-85 years, with an overall cross-sectional adherence of 71.2% and an average return time of 27.3 days. Another study focused on a large, national Spanish-speaking population, revealing an overall adherence rate of 76.7% with a mean time to test return of 20.2 days. Personalized patient navigation outreach with Spanish language support resulted in adherence rates exceeding 70% for CRC re-screening, across all analyzed age subgroups.
Additional findings include:
- A gap closure program achieved nearly 50% adherence, with an average of 25.5 days to return the kit, supporting mt-sDNA as an effective modality to enhance CRC screening participation.
- Personalized patient outreach significantly improved mt-sDNA adherence for CRC screening compared to standard outreach (63% vs 61.1%).
- Preference-based multichannel navigation with Spanish language outreach significantly improved patient adherence to CRC screening in a Federally Qualified Health Center (FQHC) Spanish-speaking population, increasing adherence from 45.10% to 51.60%.
- Overall mt-sDNA adherence was 63.7%, with SMS + email demonstrating the shortest average return time (20.1 days).
- Personalized Spanish-language outreach in a predominantly Spanish-speaking Hispanic patient population significantly improved mt-sDNA adherence rates; The Spanish language outreach group exhibited higher mt-sDNA adherence than English language outreach group (62.0% vs. 57.3%), while also exhibiting increased odds of mt-sDNA adherence.
About Cologuard and Cologuard Plus
The Cologuard test is a non-invasive colorectal cancer screening test for adults 45 and older who are at average risk for the disease. It detects certain DNA markers and blood in the stool associated with colorectal cancer and precancer. The Cologuard Plus test, developed with Mayo Clinic, features novel biomarkers, improved laboratory processes, and enhanced sample stability. Exact Sciences anticipates launching the Cologuard Plus test with Medicare coverage and guideline inclusion in 2025.
