FDA Approves Exact Sciences’ Cologuard Plus Test, Setting a New Benchmark in Non-Invasive Colorectal Cancer Screening

Cologuard Plus™ test raises the performance bar with sensitivities of 95% for colorectal cancer and 43% for advanced precancerous lesions at 94% specificity

Cologuard Plus test will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test

Company expects to launch Cologuard Plus test with Medicare coverage and guideline inclusion in 2025

Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer screening and diagnostic tests, today announced the U.S. Food and Drug Administration (FDA) approved the Cologuard Plus™ test, the company’s next generation multitarget stool DNA test. The Cologuard Plus test is now approved for adults ages 45 and older who are average risk for colorectal cancer (CRC).1

FDA approval was based on findings from the pivotal BLUE-C study, one of the largest prospective, head-to-head studies ever conducted in CRC screening. Among the subset of nearly 19,000 average-risk participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity with no findings on colonoscopy.1* Results from BLUE-C also show the Cologuard Plus test significantly outperformed an independent fecal immunochemical test (FIT**) for overall CRC sensitivity, treatable-stage CRC (stages I-III) sensitivity, high-grade dysplasia sensitivity, and advanced precancerous lesion sensitivity.2

“To meaningfully improve outcomes in colorectal cancer, we must catch cancer early – when it is most treatable – and find advanced precancers, which can prevent cases of this cancer,” said Thomas F. Imperiale, MD, professor of medicine at the Indiana University School of Medicine, research scientist at the Regenstrief Institute, and principal investigator for the BLUE-C study. “The high colorectal cancer sensitivity and specificity of the Cologuard Plus test gives me confidence in the test’s ability to do just that while simultaneously maintaining a low risk of false positives. This makes the Cologuard Plus test a strong option for first-line screening of average risk patients.”

“Cologuard Plus sets a new performance standard in non-invasive colorectal cancer screening for patients,” said Kevin Conroy, Chairman and CEO of Exact Sciences. “Cologuard Plus detects cancers and precancerous polyps with even greater sensitivity than Cologuard while reducing false positives by more than 30 percent. This breakthrough comes at a critical time, when 60 million Americans are not up to date with screening.”

CRC is often considered the most preventable, yet least prevented form of cancer.3 It remains the second deadliest cancer in the United States.4 The Cologuard Plus test will build on the success of the Cologuard® test, which has been used more than 17 million times and helped meaningfully improve national CRC screening rates in the United States.5,6 Upon launch in 2025, the Cologuard Plus test will be supported by Exact Sciences’ commercial organization and industry-leading ExactNexus™ technology platform, making ordering and resulting seamless for more than 350 health systems. The innovative, non-invasive test is anticipated to be covered by Medicare, included in the U.S. Preventive Services Taskforce (USPSTF) guidelines, and included within quality measures.

*The Cologuard Plus test demonstrates 91% specificity including non-advanced findings, 93% specificity including no findings, and 94% specificity when age-weighted to the U.S. population with no findings on colonoscopy.

**Refers to the commercially available Polymedco OC-Auto® Micro 80iFOB Test

About the BLUE-C Study

BLUE-C is a multi-center, prospective study (NCT04144738) of more than 20,000 adults 40 years of age and older. The trial was designed to evaluate the performance of the Cologuard Plus test (multi-target stool DNA or mt-sDNA) and Exact Sciences’ blood-based colorectal cancer screening test. Using colonoscopy as a reference method, the robust study design directly compared the Cologuard Plus test and an independent fecal immunochemical test (FIT*). The BLUE-C study cohort is diverse and reflective of the U.S. population. About 40% of all participants identified as Hispanic or Latino, Black, Asian, American Indian or Alaska Native, or Pacific Islander. This enrollment diversity helps ensure that the BLUE-C findings and the Cologuard Plus™ test are relevant for all screen-eligible individuals, regardless of race or ethnicity. 2

About the Cologuard Plus test

Developed in collaboration with Mayo Clinic, the Cologuard Plus test features novel biomarkers and improved laboratory processes. It also incorporates enhanced sample stability components to provide patients more time to return their sample to Exact Sciences' lab and increase the valid result rate. Exact Sciences is preparing for the commercialization of the Cologuard Plus test.

About the Cologuard test

The Cologuard test is a first-line colorectal cancer screening test for use in adults age 45 or older who are at average risk for the disease. It is included in national colorectal cancer screening guidelines by the American Cancer Society (2018) and the U.S. Preventive Services Task Force (2021).

The Cologuard test revolutionized colorectal cancer screening by providing a best-in-class, noninvasive testing option for those at average risk. The test looks for certain DNA markers and blood in the stool that are associated with colorectal cancer and precancer and was shown to effectively detect colorectal cancer and precancer in the pivotal DeeP-C study. The Cologuard test is easy to use, can be completed at home, and does not require any time off or special preparation.

About Exact Sciences Corp.

A leading provider of cancer screening and diagnostic tests, Exact Sciences gives patients and health care professionals the clarity needed to take life-changing action earlier. Building on the success of the Cologuard® and Oncotype® tests, Exact Sciences is investing in its pipeline to develop innovative solutions for use before, during, and after a cancer diagnosis. For more information, visit ExactSciences.com, follow Exact Sciences on X (formerly known as Twitter) @ExactSciences, or find Exact Sciences on LinkedIn and Facebook.

NOTE: Exact Sciences, Cologuard and Cologuard Plus are trademarks or registered trademarks of Exact Sciences Corporation. Oncotype, Oncotype DX, Oncotype DX Breast Recurrence Score, RSClin, and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners. The Cologuard and Cologuard Plus tests are not available outside of the U.S.

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. Therefore, you should not place undue reliance on forward-looking statements. Examples of forward-looking statements include, among others, statements regarding our expectations for the commercialization of Cologuard Plus, the performance of Cologuard Plus in a commercial setting, and Cologuard Plus’ receipt of Medicare coverage and inclusion in guidelines. 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.

References

1. Cologuard Plus Instructions for Use. Exact Sciences Corporation. Madison, WI.
2. Imperiale TF, Porter K, Zella J, et al. Next-generation multitarget stool DNA test for colorectal cancer screening. New Engl J Med. 2024;390(11):984-993.
3. Itzkowitz SH. Incremental advances in excremental cancer detection tests. JNCI. 2009;101(18)1225-1227.
4. ACS. Cancer facts & figures 2024. Atlanta: American Cancer Society; 2024.
5. National Institutes of Health. The Cancer Trends Progress Report. https://progressreport.cancer.gov/detection/colorectal_cancer. Accessed July 29, 2024.
6. Ebner DW, Finney Rutten LJ, Miller-Wilson LA, et al. Trends in Colorectal Cancer Screening from the National Health Interview Survey: Analysis of the Impact of Different Modalities on Overall Screening Rates. Cancer Prev Res (Phila). 2024;17(6):275-280.

 

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