MADISON, Wis., April 28, 2021 /PRNewswire/ -- Exact
Sciences (NASDAQ: EXAS) today announces study results published in
Mayo Clinic Proceedings showing that Cologuard (mt-sDNA) is
the most cost-effective colorectal cancer (CRC) screening option in
the Alaska Native population, as compared to colonoscopy and
the fecal immunochemical test (FIT), for a wide range of adherence
scenarios. According to the model, Cologuard produced the highest
number of quality adjusted life years (QALYs) gained and the
largest reduction in CRC incidence.1
Colorectal cancer is the second leading cause of cancer death
for men and women in the United
States,2 in part because many cancers go
undetected until later stages when treatment is less
effective.3 Alaska Native (AN) people have among the
nation's highest reported incidence rates for CRC, at 89.0 per
100,000 people compared to 45.7 per 100,000 people for the entire
United States. 4
Despite the clear need, screening AN people presents significant
challenges, such as lower sensitivity for cancer and pre-cancer
with other stool-based tests and obstacles around getting people
from their remote homes to healthcare facilities, which requires
significant time, expense, and support personnel.5 The
Cologuard test provides a path to overcome these barriers by
offering patients a CRC screening test that allows them to collect
their sample at home.
An earlier study from lead author Diana
Redwood, Ph.D. of the Alaska Native Tribal Health Consortium
and Alaska Native Epidemiology Center, analyzed the performance of
Cologuard, a U.S. Food & Drug Administration (FDA) approved
stool DNA test for colorectal cancer, in AN people. The study
showed the non-invasive Cologuard test had high sensitivity in
detecting colorectal cancer and large pre-cancerous lesions making
it a strong candidate for increasing the screening options
available for AN people.5
"My earlier research showed that Cologuard is an effective
screening test in Alaska Native people," Redwood said. "This study
shows Cologuard would also be a cost-effective way to screen this
unique and hard to reach population."
Each strategy reduced costs and increased QALYs in comparison
with no screening, with Cologuard outperforming FIT and colonoscopy
screening in all adherence scenarios. With perfect adherence
assumed, all screening modalities examined (colonoscopy, FIT, and
mt-sDNA) decreased CRC incidence relative to no screening, with
Cologuard decreasing incidence the most.1,5
A Markov model was used to evaluate the effects of the 3
screening tests over 40 years. Outcomes included CRC incidence and
mortality, costs, QALYs, and incremental cost-effectiveness ratios
(ICERs). The study incorporated updated evidence on screening test
performance and adherence and was conducted from December 15, 2016, through November 6, 2019.5
"Cologuard is supported by Exact Sciences' built-in patient
navigation system, which offers round the clock support for
patients. Data shows this support increases test completion rates,
especially among people, like many Alaska Native people, who
haven't been previously screened," said Paul Limburg, M.D., Chief Medical Officer,
Screening at Exact Sciences
With perfect adherence, CRC incidence was reduced by 52% using
10-yearly colonoscopy, 61% using annual FIT, and 66% using
triennial mt-sDNA screening. Compared with no screening, perfect
adherence to screening added estimates of 0.19 QALYs with mt-sDNA,
0.17 QALYs with FIT, and 0.15 QALYs per person with colonoscopy.
Colonoscopy was found to be the most expensive strategy: about
$110 million more than mt-sDNA and
$127 million more than FIT. With
best-case imperfect adherence, which represents the highest
estimated adherence rate based on the authors analysis, mt-sDNA
resulted in improvement of 0.12 QALYs/person vs. 0.05 QALYs/person
by FIT and 0.06 QALYs/person by colonoscopy. Under other adherence
scenarios, mt-sDNA either dominated or was cost-effective as
compared with FIT and colonoscopy.5
References:
- Redwood DG, Dinh TA, Kisiel JB, et al. Cost-effectiveness of
multitarget stool DNA testing vs colonoscopy or fecal
immunochemical testing for colorectal cancer screening in Alaska
Native people. Mayo Clin
Proc. 2020; xx(x):1-15.
doi:10.1016/j.mayocp.2020.07.035
- Siegel RL, Miller KD, Fuchs HE, Jemal
A. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7-33.
doi:10.3322/caac/21654
- Zauber AG, Winawer SJ, O'Brien M, et al. Colonoscopic
polypectomy and long-term prevention of colorectal-cancer deaths.
N Engl J Med. 2012;366(8):687-696.
doi:10.1056/NEJMoa110370
- ACS. Colorectal cancer facts and figures 2020-2022.
Atlanta: American Cancer Society;
2020.
- Redwood DG, Asay ED, Blake ID, et al. Stool DNA testing for
screening detection of colorectal neoplasia in Alaska Native
people. Mayo Clin Proc.
2016;91(1):61-70. doi:10.1016/j.mayocp.2015.10.008
Media Contact:
Cara
Connelly, cconnelly@exactsciences.com, 614-302-5622
Investor Contact:
Erik
Holznecht, eholznecht@exactsciences.com, 608-800-6605
Financial support and conflict of interest disclosure:
Dr. John Kisiel serves, and Dr.
David Ahlquist served as scientific
advisors to and research collaborators with Exact Sciences Corp.,
distributors of the multi-target stool DNA test (Cologuard). Exact
Sciences also provides support for Dr. Kisiel's lab and research
team at Mayo Clinic. Exact Sciences Corp. had no role in the study
design, data analyses, or manuscript preparation. Additional
Information: Coauthor David A. Ahlquist, MD, died in November 2020.
About Exact Sciences Corp.
A leading provider of
cancer screening and diagnostic tests, Exact Sciences relentlessly
pursues smarter solutions providing the clarity to take
life-changing action, earlier. Building on the success of Cologuard
and Oncotype DX, Exact Sciences is investing in its product
pipeline to take on some of the deadliest cancers and improve
patient care. 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
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) 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
precancer, 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 a
follow-up 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 Cologuard. For more
information about Cologuard, visit www.cologuard.com. Rx
Only.
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. 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.
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