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
- Cologuard Plus Instructions for Use. Exact Sciences
Corporation. Madison, WI.
- 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.
- Itzkowitz SH. Incremental advances in excremental cancer
detection tests. JNCI. 2009;101(18)1225-1227.
- ACS. Cancer facts & figures 2024. Atlanta: American Cancer
Society; 2024.
- National Institutes of Health. The Cancer
Trends Progress Report.
https://progressreport.cancer.gov/detection/colorectal_cancer.
Accessed July 29, 2024.
- 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241004761985/en/
Media (U.S.): Lindsey
Dickinson +1
608-690-0383
lidickinson@exactsciences.com Investor: Erik Holznecht +1
608-800-6605 investorrelations@exactsciences.com
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