On October 24, 2022 Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, reported the company will present new data supporting the positive impact of Cologuard as a colorectal cancer screening tool during the American College of Gastroenterology (ACG) Annual Meeting, being held October 21-26, 2022 (Press release, Exact Sciences, OCT 24, 2022, View Source [SID1234622296]). For the first time, data from Exact Sciences will detail the positive impacts on patients when costs associated with follow-up colonoscopy are eliminated after a positive stool-based test. New data will also provide details on the value of Cologuard in detecting serrated polyps, and the importance of reconsidering the definition of false positive outcomes from stool tests in CRC screening.
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"Data from Exact Sciences at ACG demonstrate the positive impact removing obstacles to colorectal cancer screening can have on clinical and economic outcomes associated with this highly preventable form of cancer," said Paul Limburg, MD MPH, AGAF, chief medical officer, Screening, Exact Sciences. "These results provide key information to help screen more people for colorectal cancer and support the use of Cologuard as an FDA-approved, non-invasive screening option that is included in U.S. Preventive Services Task Force guidelines."
ACG has accepted the following four abstracts for presentation at the 2022 Annual Meeting:
Lifetime Impact of the Change in Modality as a Result of Eliminating Cost-sharing for Follow-up Colonoscopy After a Positive Stool Test for Colorectal Cancer Screening
Presenter: A. Burak Ozbay, PhD, Exact Sciences
Session: Sunday, October 23, 2022; 5:00 PM – 7:00 PM ET
Abstract Number: #A0179
Key results: In Oregon, a policy that eliminated patient cost-sharing for follow-up colonoscopy significantly increased the uptake of colorectal cancer screening and shifted screening modalities from colonoscopy to non-invasive methods. The clinical and economic effects of these outcomes were estimated in a cohort of average-risk individuals, newly eligible for colorectal cancer screening. With a 10 percent shift from colonoscopy to stool-based testing and modest 5 percent uptake in total screening, life years gained increased by at least 5 percent while more than 1,200 cases and 900 deaths were averted per 1 million individuals at a lower cost.
Serrated Polyps in Patients with Positive FIT or Mt-sDNA, or Colonoscopy Only: Data from the New Hampshire Colonoscopy Registry
Presenter: Dr. Joseph Anderson, MD, MHCDS, FACG, Dartmouth College
Session: Sunday, October 23, 2022; 5:00 PM – 7:00 PM ET
Abstract Number: #A0168
Key results: Serrated polyps progress to colorectal cancer through methylation and may account for up to 30 percent of all colorectal cancers. In this registry study, patients screened with Cologuard had a higher yield of serrated polyps found during colonoscopy than those screened with a FIT test or colonoscopy alone. When stratified by large adenomas, 18 percent of the Cologuard-positive patients had clinically relevant serrated polyps compared to 10 percent for FIT and 8 percent for colonoscopy patients. A regression model showed that the Cologuard-positive patients were nearly 3 times as likely to have clinically relevant serrated polyps than colonoscopy patients.
What Do ‘False-Positive’ Stool Tests Really Mean? Data from the New Hampshire Colonoscopy Registry
Presenter: Joseph Anderson, MD, MHCDS, FACG, Dartmouth College
Session: Sunday, October 23, 2022; 5:00 PM – 7:00 PM ET
Abstract number: #A0169
Key results: Using a definition of positive colonoscopy that includes significant precancerous findings demonstrated a substantial decrease in false discovery rates and a corresponding increase in positive predictive value. Using the strictest definition of positive colonoscopy (only including advanced adenomas and cancer) compared to the least strict (including serrated adenomas and certain hyperplastic polyps), the percent of positive Cologuard tests with a negative follow-up colonoscopy decreased from 72 percent to 32 percent and the positive predictive value increased from 28 percent to 68 percent.
Algorithm Training and Independent Test Set Performance for a Molecular Non-Endoscopic Test for Detection of Esophageal Adenocarcinoma and Barrett’s Esophagus in Multicenter Cohorts
Presenter: Prasad G. Iyer, MD, FACG, Mayo Clinic
Session: Tuesday, October 25, 2022; 3:00 PM – 5:00 PM ET
Abstract number: #E0195
Key results: An assay using three methylated DNA markers and one reference marker demonstrated overall sensitivity for Barrett’s esophagus and esophageal adenocarcinoma of 81% at 90% specificity in the training set and 88% sensitivity at 84% specificity in the test set.
As part of Exact Sciences’ ongoing efforts to advance scientific understanding in colorectal cancer screening, the company is also pleased to announce the publication of a manuscript titled "Patterns of initial colorectal cancer screenings after turning 50 years old and follow-up rates of colonoscopy after positive stool-based testing among the average-risk population" in Current Medical Research & Opinion. The study found potential for improving colorectal cancer screening among the eligible average-risk population, both to start screening once they reach the screening-eligible age, and to complete the screening paradigm after a positive stool-based test.