On January 18, 2022 Exact Sciences reported performance data for a second-generation Cologuard (multi-target stool DNA) test showing overall sensitivity of 95.2% for colorectal cancer (CRC) at specificity of 92.4% for negative samples confirmed by colonoscopy (Press release, Exact Sciences, JAN 18, 2022, View Source [SID1234605599]). Subgroup analyses showed 83.3% sensitivity for high-grade dysplasia, the most dangerous precancerous lesions, and 57.2% for all advanced precancerous lesions. These data will be presented January 22 at ASCO (Free ASCO Whitepaper) GI in a poster titled, "Second-generation Multi-target Stool DNA Panel Reliably Detects Colorectal Cancer and Advanced Precancerous Lesions."

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Cologuard is the first and only FDA-approved, non-invasive stool DNA test used to screen average-risk people for CRC. Exact Sciences is developing a second-generation Cologuard to improve the specificity and precancer sensitivity of the test, decreasing the false positive rate and increasing the detection rate of precancerous lesions. The study shows the potential of a highly discriminate panel of methylated DNA markers and fecal hemoglobin to accomplish both in a real-world setting. If approved, the second-generation Cologuard test could help increase screening rates while sending fewer people to follow-up colonoscopies unnecessarily and identifying more advanced precancers before they progress to cancer, helping prevent the disease.

"The Exact Sciences team is constantly innovating to help make earlier cancer detection a routine part of medical care," said Kevin Conroy, chairman and CEO. "These data demonstrate our commitment to patients and the power of our research and development teams, scientific platform, and expertise in colorectal cancer screening."

The study was carefully designed to simulate a true screening population and better predict real-world, prospective performance of the marker panel. It included non-advanced precancers, samples collected prospectively across all precancer types and sizes, and colorectal cancer samples weighted heavily towards early stages. The study consisted of 777 stool samples collected in the United States and Canada across 134 sites, including 112 cancers – 78% in stages I and II, 98 prospectively collected advanced precancerous lesions, 176 non-advanced precancerous lesions, and 391 negative controls.

"Exact Sciences and Mayo Clinic scientists worked together to discover these new methylation markers, which demonstrate improved performance over first-generation Cologuard markers," said Paul Limburg, MD, MPH, AGAF, Chief Medical Officer for Screening at Exact Sciences. "In particular, the observed increased specificity suggests that false positive screening results can be reduced, which has important implications for clinical practice and decision-making."

Colorectal cancer is the second deadliest cancer impacting both men and women in the United States. It’s also treatable if caught in early stages.1 Despite the benefits of CRC screening, approximately 45 million average-risk people in the United States remain unscreened.2 A multi-center pivotal trial evaluating second-generation Cologuard markers is ongoing, and results are expected late 2022 or early 2023. Exact Sciences plans to use results of the ongoing trial to support an FDA submission and approval and make the enhanced Cologuard test available broadly.

Conference call and webcast details

Exact Sciences management and Mayo Clinic will host a conference call and webcast on Wednesday, Jan. 19, 2022, at 11 a.m. ET to discuss results of the second-generation Cologuard study. The webcast will be available at www.exactsciences.com. Domestic callers should dial (833) 952-1519 and international callers should dial +1 236-714-2125. The access code for both domestic and international callers is 3972189.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or +1-416-621-4642 internationally. The access code for the replay of the call is 3972189. The webcast, conference call, and replay are open to all interested parties.

Additional data presented at 2022 ASCO (Free ASCO Whitepaper) GI Cancers Symposium

Four additional Exact Sciences abstracts were accepted and will be shared at ASCO (Free ASCO Whitepaper) GI. Details for each are included below and all abstracts can be found on the conference website.

Cologuard abstracts

Title: Patterns of Colorectal Cancer (CRC) Screening Rates Among the Average Risk US Population
Authors: Fisher, D., et al.
Date/Time: Jan. 22, 2022, 9:30 a.m. ET

Title: Preferences for Colorectal Cancer Screening of Physicians and Individuals at Average Risk in the United States: A Discrete Choice Experiment
Authors: Heidenreich, et al.
Date/Time: Jan. 22, 2022, 9:30 a.m. ET

Oncoguard Liver abstracts

Title: A Prospective Trial to Evaluate the Performance of the Multi-Target Hepatocellular Carcinoma Blood Test (mt-HBT) for Screening At-Risk Patients: The ALTUS Study
Authors: John, B., et al.
Date/Time: Jan. 21, 2022, 3:05 p.m. ET

Title: Multi-Target Blood Test Can Improve the Performance of Hepatocellular Carcinoma Surveillance Programs: A Modeling-Based Virtual Trial
Authors: Chhatwal, J., et al.
Date/Time: Jan. 21, 2022, 3:05 p.m. ET

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