American College of Gastroenterology (ACG)
gives BLUE-C study late breaker status at 2023 annual meeting with
presentation of the only head-to-head study results versus FIT at
ACG
High specificity for next-generation Cologuard
test expected to minimize unnecessary follow-up colonoscopies,
supporting positive patient experiences1
MADISON,
Wis., Oct. 22, 2023 /PRNewswire/ -- Exact
Sciences Corp. (NASDAQ: EXAS), a leading provider of cancer
screening and diagnostic tests, today announced late-breaking data
from the pivotal BLUE-C trial showing the next-generation
Cologuard® test met all study endpoints, demonstrating
94 percent sensitivity for colorectal cancer (CRC) at 91%
specificity, during the American College of Gastroenterology (ACG)
Annual Meeting 2023.[1] Additionally, results show the
next-generation Cologuard test was significantly more likely to
detect cancer or precancer than fecal immunochemical testing (FIT)*
(94% vs 67% and 43% vs 23%, respectively).[1]
Finally, the next-generation Cologuard test
demonstrated higher sensitivity for the most clinically significant
form of advanced precancerous lesions (high-grade dysplasia at 75%)
than FIT (47%).[1]
Results show next-generation Cologuard test
superior to FIT in sensitivity for colorectal cancer and
pre-cancers
BLUE-C is one of the largest, most robust CRC screening
trials ever conducted. It included more than 20,000 evaluable
subjects in a population that aligns to the racial and ethnic
diversity of the United
States.[1,2] Among these participants, the BLUE-C
trial identified a total of 98 participants with colorectal cancer.
Of these 82 (83.7%) had stage I to III
cancers.[1]
"BLUE-C results demonstrate a new standard in non-invasive
colorectal cancer and precancer detection, building on the
strengths of current Cologuard," said Paul
Limburg, MD, MPH, AGAF, chief medical officer, Screening,
Exact Sciences. "The high sensitivity and specificity reported in
BLUE-C will help drive improvement in patient experiences and will
contribute to our quest to improve outcomes for this deadly cancer
via accurate early detection."
Most advanced
colonoscopy
finding (index
lesion)
|
Next-gen
Cologuard
(N=20,176)
|
FIT
(N=20,176)
|
|
Sensitivity
(%)
|
Sensitivity
(%)
|
CRC, any
|
94
|
67
|
Stage I-III
|
93
|
65
|
Advanced Pre-
Cancerous Lesions
(APLs)
|
43
|
23
|
High-grade
dysplasia
|
75
|
47
|
Note: FIT positivity cut-off: hemoglobin >100 ng/mL.
Colorectal cancer stages were defined per the American Joint
Committee on Cancer Staging System, 8th ed.
BLUE-C Reports High Specificity
In addition to superiority over FIT in sensitivity for both
colorectal cancer and advanced precancerous lesions, the
next-generation Cologuard test demonstrated 91%
specificity.1 The specificity for FIT was
95%.[1]
"Improving specificity of non-invasive stool-based screening
tests while maintaining high sensitivity is a critical step in
advancing the detection and prevention of colorectal cancer and
minimizing the potential for unnecessary follow-up colonoscopies,"
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 BLUE-C.
The 91% specificity reported in the BLUE-C trial for patients
without advanced neoplasia is higher than the 87% specificity
reported in Deep-C, the FDA registrational trial for
Cologuard.[1,3] For patients with a negative or
non-neoplastic findings on colonoscopy, specificity for the
next-generation Cologuard test reached 93%. In this category, the
specificity for FIT was 96%.[1]
Additional Analysis Presented at ACG Further Supports
Performance of Next-Generation Cologuard
In addition to the BLUE-C pivotal data shared at ACG, Exact
Sciences presented an analysis that describes a performance
evaluation and validation of the next-generation Cologuard
algorithm using a set of known test samples from the original
Cologuard pivotal study (DeeP-C). In this additional analysis, all
performance estimates of next-generation Cologuard performance were
equivalent to or higher than the first-generation Cologuard test,
confirming reproducibility and supporting clinically relevant
performance of the next-generation Cologuard
test.[4]
"Promising data from the BLUE-C trial involving 20,000 patients
is being presented at the American College of Gastroenterology,"
said Seth A. Gross, MD, professor of
medicine, NYU Grossman School of Medicine. "The findings indicate
that the next-generation mt-sDNA test demonstrates even higher
sensitivity for colorectal cancer screening (94%) and high-grade
dysplasia (75%), compared with the current Cologuard test.
These findings suggest that, if FDA approved, the mt-sDNA test will
be a valuable option in providing non-invasive colorectal cancer
screening."
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 next-generation Cologuard (multi-target stool
DNA or mt-sDNA). Using colonoscopy as a reference method, the
robust study design compared next-generation Cologuard and a fecal
immunochemical test (FIT*). Blood samples were also
collected for later evaluation of a blood-based screening test
being developed by Exact Sciences. BLUE-C is one of the largest
colorectal cancer 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 Next-Generation Cologuard
Developed in
partnership with Mayo Clinic, the next-generation Cologuard 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.
In the coming months, Exact Sciences plans to release additional
analyses of the BLUE-C data and complete its application to the FDA
for approval of next-generation Cologuard.
About Cologuard
Cologuard revolutionized colorectal cancer screening by
providing a convenient and accurate testing option for those at
average risk. Nearly a decade later, Cologuard has been used to
screen for colorectal cancer more than 12 million times.
Results from Exact Sciences' prospective, 90-site,
point-in-time, 10,000-patient pivotal trial, DeeP-C, were published
in the New England Journal of Medicine in March 2014. The Cologuard test is included in the
American Cancer Society's (2018) colorectal cancer screening
guidelines and the recommendations of the U.S. Preventive Services
Task Force (2021) and National Comprehensive Cancer Network (2023).
The Cologuard test 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
the Cologuard test if you have had precancer, have inflammatory
bowel disease and certain hereditary syndromes, or have a personal
or family history of colorectal cancer. The Cologuard test is not a
replacement for colonoscopy in high-risk patients. The Cologuard
test performance in adults ages 45-49 is estimated based on a large
clinical study of patients 50 and older. The Cologuard test
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
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. Medicare and most
major insurers cover the Cologuard test. For more information about
the Cologuard test, visit cologuard.com. Rx only.
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 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 next-generation Cologuard test; the
performance characteristics of next-generation Cologuard in a
commercial setting; and the timing and anticipated results of
additional analysis of the BLUE-C data and 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 80iFOB
Test
References
- Imperiale T, et al. Oral Presentation 54, ACG 2023.
- 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
- Imperiale TF, et al. N Engl J Med.
2014;370(14):1287-1297.
- Imperiale T, et al. P0358, ACG 2023.
Media (U.S.):
Lindsey
Dickinson
|
Investor:
Megan
Jones
|
+1 608-690-0383
|
+1 608-535-8815
|
lidickinson@exactsciences.com
|
meganjones@exactsciences.com
|
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