Cologuard Plus is only noninvasive test to be
evaluated head-to-head against an independent fecal immunochemical
test, which it significantly outperformed
20,000-participant BLUE-C study included 98
colorectal cancers and reflects racial and ethnic diversity of
U.S.
Company will host conference call and webcast
at 8:00 a.m. ET on March 14 to discuss study results
Exact Sciences Corp. (NASDAQ: EXAS), a leading provider of
cancer screening and diagnostic tests, today announced online
publication of the BLUE-C study results in The New England Journal
of Medicine. The peer-reviewed study, "Next-Generation Multitarget
Stool DNA Test for Colorectal Cancer Screening", will also appear
in the journal's March 14, 2024 print issue.
The 20,000-participant BLUE-C study was designed to determine
the performance characteristics of Exact Sciences’ next-generation
multitarget stool DNA test, Cologuard Plus, for colorectal cancer
(CRC) and to compare that performance to the fecal immunochemical
test (FIT), a commonly used noninvasive CRC screening test. Exact
Sciences submitted to the U.S. Food and Drug Administration (FDA)
its pre-market approval (PMA) application for Cologuard Plus in
December 2023, including complete results from BLUE-C, and plans to
make the test available in 2025, pending approval.
Cologuard Plus met all BLUE-C study endpoints, demonstrating 94%
sensitivity for CRC at 91% specificity including non-advanced
findings, and 93% specificity including no findings. Specificity
was even better in younger age groups, at 96% in 45-54 year olds.
Cologuard Plus will minimize unnecessary follow-up colonoscopies by
reducing the likelihood of a false-positive screening test.
Results from BLUE-C also show Cologuard Plus significantly
outperformed an independent FIT* for overall CRC sensitivity,
treatable-stage CRC (stages I-III) sensitivity, high-grade
dysplasia sensitivity, and advanced precancerous lesion
sensitivity.
Cologuard Plus1
Independent FIT1
Cancer sensitivity
94
67
Specificity including non-advanced
findings
91
95
Specificity including no findings
93
96
Stages I-III cancer sensitivity
93
65
High-grade dysplasia sensitivity
75
47
Advanced precancer sensitivity
43
23
Note: specificity including non-advanced
findings includes colonoscopy results that were negative for cancer
or advanced precancer upon histopathological review; specificity
including no findings includes no findings on colonoscopy and no
histopathological review; high-grade dysplasia is a subtype of
advanced precancer that includes carcinoma in situ or stage 0
cancer
To potentially expand the eligible screening population beyond
average-risk patients, the BLUE-C study enrolled a small subset of
participants with a first-degree relative with a history of CRC.
Sensitivities for CRC and advanced precancerous lesions were
similar among participants with a first-degree relative with a
history of CRC and those without such a relative.
Among the subset of nearly 19,000 participants who were
average-risk, without a first-degree relative with a history of
CRC, Cologuard Plus exhibited 95% sensitivity for CRC and 43%
sensitivity for advanced precancerous lesions at a 91% specificity
including non-advanced findings, or 94% specificity including no
findings.
“Cologuard Plus is highly sensitive for detecting colorectal
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. “This noninvasive test also detected a good proportion of
the most advanced precancerous lesions, and did so with a low
number of false-positive test results.”
The prospective, multi-center BLUE-C study utilized colonoscopy
as a reference method, directly comparing Cologuard Plus and an
independent FIT. BLUE-C investigators also collected blood samples
for evaluation of a blood-based CRC screening test developed by
Exact Sciences.
“BLUE-C’s publication in The New England Journal of Medicine
reflects a decade of deep scientific and medical research in
collaboration with Mayo Clinic,” said Kevin Conroy, chairman and
CEO of Exact Sciences. “We’re eager to bring an improved,
noninvasive colorectal cancer screening test to patients in
Cologuard Plus, as colorectal cancer remains the most preventable,
yet least prevented cancer.”
The BLUE-C study cohort was 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 Cologuard Plus are relevant for all screen-eligible
individuals, regardless of race or ethnicity.
“Many of the 53,000 Americans killed by colorectal cancer each
year come from communities of color, a disparity we must work
together to eliminate,” said Gary A. Puckrein, Ph.D., president and
chief executive officer of National Minority Quality Forum. “Access
to innovations in colorectal cancer screening like the Cologuard
Plus test and navigation that helps people get screened will play
an important role in helping reduce the disproportionate and deadly
impact colorectal cancer has on communities of color.”
Conference call and webcast details
Exact Sciences management will host a conference call and
webcast on March 14 at 8:00 a.m. ET to discuss results of the
pivotal BLUE-C study. The webcast will be available at
www.exactsciences.com. Domestic callers should dial (800) 715-9871
and international callers should dial +1 646-307-1963. The access
code for both domestic and international callers is 5347907. An
archive of the webcast will be available at www.exactsciences.com.
The webcast, conference call, and replay are open to all interested
parties.
About the BLUE-C Study
BLUE-C was a multi-center, prospective study (NCT04144738) of
more than 20,000 adults 40 years of age and older.1 The trial was
designed to evaluate the performance of Cologuard Plus (next
generation multitarget stool DNA or mt-sDNA). Using colonoscopy as
a reference method, the robust study design directly compared
Cologuard Plus and an independent FIT. Blood samples were also
collected for evaluation of a blood-based screening test developed
by Exact Sciences. BLUE-C is one of the largest, noninvasive CRC
screening trials ever conducted, and the study population reflects
the racial and ethnic makeup of the United States according to the
2020 census.1,2
About Cologuard Plus
Developed in collaboration with Mayo Clinic, Cologuard Plus
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
FDA approval and the commercialization of Cologuard Plus.
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 and Cologuard Plus are trademarks or
registered trademarks of Exact Sciences Corporation. Oncotype is a
registered trademark of Genomic Health, Inc., a wholly-owned
subsidiary of Exact Sciences Corporation. All other trademarks and
service marks are the property of their respective owners.
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 we make regarding the
development and commercialization of the Cologuard Plus test; the
performance characteristics and healthcare benefits of Cologuard
Plus in a commercial setting; and the timing and anticipated
results of FDA submission. 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.
*The commercially-available Polymedco OC-Auto® Micro 80 iFOB
Test
References
- Imperiale T, et al. N Engl J Med (2024)
- United States Census Bureau. Annual Estimates of the Resident
Population by Single Year of Age and Sex for the United States:
April 1, 2020 to July 1, 2022 (NC-EST2022-AGESEX-RES). Accessed 16
October 2023.
https://www.census.gov/data/tables/time-series/demo/popest/2020s-national-detail.html
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240313292947/en/
Media (U.S.): Lindsey Dickinson +1 608-690-0383
lidickinson@exactsciences.com
Investor: Nathan Harrill +1 608 535-8659
investorrelations@exactsciences.com
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