Data demonstrate long-term impact of the
Cologuard test, a powerful tool for preventing and detecting
cancer
Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of
cancer screening and diagnostic tests, shared new modeling data
today describing the projected impact of the Cologuard test on
patients, health care professionals, and the U.S. health care
system since its FDA approval 10 years ago.
The data assessed the far-reaching benefits of the first and
only multi-target stool DNA test for patients, their families, and
the health care system. Over the past 10 years, the Cologuard test
has been used to screen for colorectal cancer (CRC) more than 16
million times.
The Cologuard test is the most effective noninvasive option for
CRC screening1 and an important tool for closing the gap of 60
million Americans not up to date with screening.2 According to data
from the Centers for Disease Control and Prevention (CDC),
Cologuard test use is the primary contributor to the increase in
colon cancer screening rates from 63% in 2015 to 72% in 2021 among
Americans ages 50-75.3 In addition, a new study from EPIC research
showed the number of people ages 45-49 completing screening with
the Cologuard test tripled from 2021 to 2023.4
“As Exact Sciences marks the 10th anniversary of Cologuard, we
reflect on the vital role that it has played in the prevention and
early detection of colorectal cancer, making screening more
accessible and effective for patients,” said Kevin Conroy, chairman
and CEO of Exact Sciences. “We reached this milestone thanks to
long-standing partnerships from health care professionals and
advocacy organizations, as well as the support of our dedicated
team. With our next-generation Cologuard test currently under FDA
review, we look forward to bringing patients a new level of
accuracy and innovation in at-home testing.”
10 years of patient impact
The modeled data projects that over the past 10 years5*:
- There have been more than 16 million completed screenings with
the Cologuard test, or approximately one every 20 seconds.
- The Cologuard test detected 525,000 people with advanced
precancerous lesions — growths most likely to advance to cancer.
Removal of these growths can help prevent cancer.
- 80% of cancers detected by the Cologuard test were early-stage
cancers.
- 42,000 people were identified to have stage I. By detecting
cancer earlier, patients are less likely to need chemotherapy or
radiation treatment, sparing them and their families that difficult
experience.
“Colorectal cancer is the number two cancer killer6, but it
doesn’t need to be this way. We have very effective tools to find
the precursors to this cancer and also to detect these cancers at
earlier, more curable stages,” said Dr. Folasade May, director of
quality in digestive diseases at UCLA Health and co-founder and
board member of the Association of Black Gastroenterologists and
Hepatologists. “With the convenience of a noninvasive use-at-home
test and ability to find more than 90% of cancers as well as many
pre-cancers7, Cologuard is unique among non-invasive tests. That’s
why I recommend it as an option to average-risk individuals who
prefer to screen with a home-based option.Ӡ
Improvements in CRC screening participation, health care and
the economy
The strong performance of the Cologuard test has also positively
impacted CRC screening rates, the economy, health care access and
costs. The modeled data projected that since the Cologuard test was
introduced5*:
- More than $22B has been saved in health care costs due to
pre-cancer and early cancer detection as compared to no
screening.5,8,9*
- The Cologuard test contributed to 77% of the improvement in CRC
screening rates between 2018 and 2021.9
- Health care staff were able to reduce hours spent toward
screening average risk and asymptomatic people, allowing them to
focus on treating people with symptoms and those who are high risk
with colonoscopies. The projections show use of the Cologuard test
as an alternative to colonoscopy in eligible patients has helped
save:
- 2.1 million scheduling hours5,10*
- 3.5 million nursing hours5,10*
- 1.1 million provider hours5,10*
During a time when at-home health and wellness tests were
relatively limited, the Cologuard test transformed CRC screening
access. Within a decade, more people screened for colorectal cancer
than ever before because of the Cologuard test — playing a critical
role in addressing the screening gap for average-risk adults that
colonoscopies and other tests cannot close alone. Data show that if
colonoscopy were the only tool available, it would take more than
10 years to address the backlog.1,5,11
“I was 47 when I screened with Cologuard,” said Katie Hawbaker,
a stage II CRC survivor. “Early detection is everything. Finding
out I had a cancerous mass was a huge shock, but I have lots to be
thankful for — I needed no chemo or radiation because my cancer was
caught early.”
Exact Sciences continues to invest in innovation and
improvements to the Cologuard test, emphasizing the company’s
commitment to revolutionizing CRC screening and closing the
screening gap. The next-generation Cologuard test is under review
with the U.S. Food and Drug Administration.
*Estimates are based on modeling projections using performance
data from the pivotal DeeP-C study † Dr. Folasade May has provided
consulting services for Exact Sciences. She has not been
compensated for any media work.
1. Fendrick AM, Fisher DA, Saoud L, Ozbay AB, Karlitz JJ,
Limburg PJ. Impact of Patient Adherence to Stool-Based Colorectal
Cancer Screening and Colonoscopy Following a Positive Test on
Clinical Outcomes. Cancer Prev Res (Phila). 2021;14(9):845-850.
doi:10.1158/1940-6207.CAPR-21-0075 2. Ebner DW, Kisiel JB, Fendrick
AM, et al. Estimated Average-Risk Colorectal Cancer
Screening-Eligible Population in the US. JAMA Netw Open.
2024;7(3):e245537. 3. National Institutes of Health. The Cancer Trends Progress Report.
https://progressreport.cancer.gov/detection/colorectal_cancer.
Accessed July 29, 2024. 4. Epic Research. DNA Stool Tests for
Colorectal Cancer Screening Growing in Popularity, Especially for
Patients Under Age 50. May 14, 2024.
https://www.epicresearch.org/articles/dna-stool-tests-for-colorectal-cancer-screening-growing-in-popularity-especially-for-patients-under-age-50.
Accessed July 29, 2024. 5. Estes C, Dehghani M, Ozbay A, et al.
Clinical, social and economic impacts of colorectal cancer
screening with the multi-target stool-DNA test: 10-year experience
– a simulated study. MedRxiv.org
https://doi.org/10.1101/2024.08.07.24311643 6. ACS. Cancer facts
& figures 2024. Atlanta: American Cancer Society; 2024. 7.
Imperiale TF, Ransohoff DF, Itzkowitz SH, et al. Multitarget stool
DNA testing for colorectal-cancer screening. N Engl J Med.
2014;370(14):1287-1297. 8. Fitch K, Pyenson B, Blumen H, et al. The
value of colonoscopic colorectal cancer screening of adults aged 50
to 64. National Library of Medicine. 2015; 21(7):e430-8. Accessed
June 27, 2024. https://pubmed.ncbi.nlm.nih.gov/26295271/ 9. 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. 10. Horejsi A,
Roberts, C, Walter J, et al. Augmenting Intelligence &
Amplifying Health: Proactive Outreach for Enhanced Preventive
Screening. Mayo Foundation for Medical Education and Research.
2024. Accessed June 27, 2024.
https://www.ache.org/-/media/ache/learning-center/research/2024-poster-presentation-posters/poster-13.pdf?_sm_nck=1
11. Joseph DA, Meester RG, Zauber AG, et al. Colorectal cancer
screening: Estimated future colonoscopy need and current volume and
capacity [published correction appears in Cancer. 2017 Oct
1;123(19):3857]. Cancer. 2016;122(16):2479-2486.
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)1 and the U.S.
Preventive Services Task Force (2021)2.
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 phase 3 DeeP-C study.3 The Cologuard test is easy to
use. It can be completed at home and does not require any time off
or special preparation. In the initial 10 years since launch, the
Cologuard test was used more than 16 million times.
Important information about the Cologuard test
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, 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. Cologuard is not available outside of the U.S.
Exact Sciences’ multi-cancer early detection test is still in
development.
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. 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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version on businesswire.com: https://www.businesswire.com/news/home/20240815674105/en/
Media Contact (U.S.): Lindsey Dickinson +1 608-690-0383
lidickinson@exactsciences.com
Investor Contact: Erik Holznecht +1 608-800-6605
investorrelations@exactsciences.com
EXACT Sciences (NASDAQ:EXAS)
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