Exact Sciences Presents Data Showing Improved Accuracy of Second-generation Cologuard® Test and Progress Toward an Even Better Colorectal Cancer Screening Solution for Patients

MADISON, Wis., Jan. 18, 2022 /PRNewswire/ -- Exact Sciences Corp. (NASDAQ: EXAS) today announced 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. 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 GI in a poster titled, "Second-generation Multi-target Stool DNA Panel Reliably Detects Colorectal Cancer and Advanced Precancerous Lesions."

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 GI Cancers Symposium

Four additional Exact Sciences abstracts were accepted and will be shared at ASCO 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

# # #

Media Contact:

Cara Connelly, [email protected], 614-302-5622

Investor Contact:

Megan Jones, [email protected], 608-535-8815

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences relentlessly pursues smarter answers to give people the clarity to take life-changing action, earlier. Building on the success of Cologuard and Oncotype^® tests, Exact Sciences is investing in its product pipeline to support patients throughout their cancer diagnosis and treatment. Exact Sciences unites visionary collaborators to help advance the fight against 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.

Note: Oncotype is a registered trademark of Genomic Health, Inc. Exact Sciences and Cologuard are trademarks or registered trademarks of Exact Sciences Corporation.

About Cologuard

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 in adults 50 years of age or older were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society's (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016, 2021) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had adenomas, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high-risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again. False positives and false negative results can occur. In a clinical study, 13% of people without cancer received a positive result (false positive) and 8% of people with cancer received a negative result (false negative). Rx only.

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuard.com.

Forward-Looking Statements

This news release contains forward-looking statements concerning our expectations, anticipations, intentions, beliefs or strategies regarding the future.  These forward-looking statements are based on assumptions that we have made as of the date hereof and are subject to known and unknown risks and uncertainties that could cause actual results, conditions and events to differ materially from those anticipated. There can be no assurance that we will successfully develop, launch, or market a Second-Generation Cologuard test, or any other new or improved product or service. Therefore, you should not place undue reliance on forward-looking statements. Risks and uncertainties that may affect our forward-looking statements are described in the Risk Factors sections of our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

SOURCE EXACT SCIENCES CORP