MADISON, Wis., May 5, 2020 /PRNewswire/ -- New research
from Exact Sciences Corp. (NASDAQ: EXAS) uses real-world-adjusted
adherence rates in a colorectal cancer microsimulation, the
Colorectal Cancer and Adenoma Incidence and Mortality model
(CRC-AIM), to reinforce the value of Cologuard (mt-sDNA) as an
effective colorectal cancer screening test. Cologuard offers
significant advantages over the fecal immunochemical test (FIT) and
real-world adherence data further highlights those advantages.
Cologuard has higher sensitivity, a longer interval, and higher
observed adherence rates in real-world usage. The modeling also
highlights the importance of improving access to colonoscopy
following a positive Cologuard or FIT test.
These results were accepted for presentation at DDW 2020 in a
series of abstracts. They are now available on the DDW website.
Colorectal cancer (CRC) is the second leading cause of cancer
death for men and women, in part because many cancers go undetected
until later stages when treatment options are limited.1
Colorectal cancer can be prevented or detected early through
screening; however, approximately 45 million Americans are not up
to date with CRC screening.2
"Policymakers and other leaders often rely on modeling to make
decisions about colorectal cancer screening," said Dr. Paul Limburg, Chief Medical Officer of Exact
Sciences' screening business. "Modeling that incorporates real-life
patient behaviors, and the impact of those behaviors on health
outcomes, is limited. This new suite of abstracts provides insight
into the effect that complex and dynamic patient patterns have on
colorectal cancer screening outcomes."
Included below are titles, abstract numbers, and a brief summary
of each abstract accepted for presentation at DDW.
Estimating the Impact of Imperfect Adherence to Stool-based
Colorectal Cancer Screening Strategies on Comparative Effectiveness
using the CRC-AIM Microsimulation Model
Abstract Number:
Mo1598
Real-life adherence rates for CRC screening are imperfect and
can vary widely by modality, health system setting, and use of
patient compliance navigation programs. Cologuard (mt-sDNA) was
recently shown to have high population-level adherence in a
Medicare population, which researchers theorized was attributable
to its noninvasive approach, widespread accessibility, and embedded
patient navigation system. Using real-world adherence rates of 70%
for mt-sDNA3 and 40-50% for FIT,4 the CRC-AIM
microsimulation model estimated that the use of mt-sDNA resulted in
an 8.4% to 19.1% increase in life-years gained (LYG) compared with
FIT for screening ages 50-75 years.
More Fecal Immunochemical Tests are Needed to Match the
Clinical Benefit of Equivalent Numbers of Multitarget Stool DNA
Tests: CRC-AIM Microsimulation Model Results
Abstract
Number: Su1773
Patient adherence to the annual testing regimes of FIT has
proven difficult to achieve in real world settings.5
Predicted outcomes of annual FIT and triennial mt-sDNA were
simulated for 4 million individuals between 50 and 75. At least
twice as many FIT tests are needed to match the same clinical
benefit compared with mt-sDNA testing (21 vs. 9) using guideline
recommended CRC screening initiation age and test interval.
Microsimulation Study of Life-Years Gained from Screening vs.
Follow-up Colonoscopy using the CRC-AIM Model
Abstract
Number: Sa1658
Health care providers often face a challenge ensuring patient
adherence to follow-up colonoscopy after a positive stool-based
test. Current reimbursement and coverage policies can trigger
patient cost-sharing when patients seek necessary follow-up
colonoscopy or when a screening colonoscopy turns diagnostic,
depending upon health insurance benefits. In a third study
leveraging the CRC-AIM model, the analysis showed that there are
approximately 3-to-5 times more LYG per colonoscopy when the
colonoscopy was performed as a diagnostic follow-up to a positive
stool-based test rather than as a screening colonoscopy alone.
"All too often, colonoscopies following a positive stool-based
test and screening colonoscopies that turn diagnostic do not
receive full reimbursement from insurers, which can prevent
patients from scheduling them," said Kevin
Conroy, chairman and CEO. "These data show the urgent need
to remove cost barriers for these colonoscopies as they have a
measurable positive impact on patient lives."
Higher Impact on Clinical Outcomes from Delays in Colorectal
Cancer Screening with the Fecal Immunochemical Test vs. Multitarget
Stool DNA: CRC-AIM Microsimulation Model Results
Abstract
Number: Tu1822
One obstacle to CRC screening is a delay in the start of
screening or a lack of adherence to repeat testing. For example,
screening rates among people 50 to 54 years old are only 50%,
according to recent CDC data.6 The assumption in this
modeling analysis was that recommended triennial mt-sDNA or annual
FIT was delayed by 12, 18, or 24 months every time screening was
due. The reduction in CRC-related mortality with a 12, 18, and
24-month delay for patients 50 to 75 was greater with triennial
mt-sDNA (67%, 63%, and 59%, respectively) than annual FIT (65%,
59%, and 53%). The relative efficacy of mt-sDNA was better than FIT
when considering these clinically realistic delayed screening
adherence scenarios.
To promote transparency and the credibility of this new model,
Exact Sciences has made available CRC-AIM's formulas and parameters
at https://github.com/CRCAIM/CRC-AIM-Public so other
researchers and members of the modeling community can address
outstanding questions related to CRC screening.
Media Contact:
Cara
Connelly, cconnelly@exactsciences.com, 614-302-5622
Investor Contact:
Megan
Jones, meganjones@exactsciences.com, 608-535-8815
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
diagnostic 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.cologuardtest.com. Rx
Only.
Forward-Looking Statements
This news release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended,
that are intended to be covered by the "safe harbor" created by
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forward-looking statements include, among others, statements we
make regarding expected future operating results, anticipated
results of our sales, marketing and patient adherence efforts,
expectations concerning payer reimbursement and regulatory matters,
the anticipated results of our product development efforts and the
anticipated benefits of our combination with Genomic Health, Inc.,
including estimated synergies and other financial impacts.
Forward-looking statements are neither historical facts nor
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of these forward-looking statements. Important factors that could
cause our actual results and financial condition to differ
materially from those indicated in the forward-looking statements
include, among others, the following: uncertainties associated with
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and flexibly manage our business amid uncertainties related to
COVID-19; our ability to successfully and profitably market our
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by patients and healthcare providers; our ability to meet demand
for our products and services; the success of our efforts to
facilitate patient access to Cologuard via telehealth, the
willingness of health insurance companies and other payers to cover
our products and services and adequately reimburse us for such
products and services; the amount and nature of competition in the
cancer detection, treatment guidance and monitoring space; the
effects of the adoption, modification or repeal of any law, rule,
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including without limitation as a result of any judicial, executive
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Cancer Society, and the National Committee for Quality Assurance
regarding cancer screening or our products and services; our
ability to successfully develop new products and services and
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utilize strategic partnerships, such as through our Promotion
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arrangements; our ability to maintain regulatory approvals and
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from our combination with Genomic Health cannot be realized in full
or at all or may take longer to realize than expected; the
possibility that costs or difficulties related to the integration
of Genomic Health's operations will be greater than expected and
the possibility of disruptions to our business during integration
efforts and strain on management time and resources; the outcome of
any litigation, government investigations, enforcement actions or
other legal proceedings; and the other risks and uncertainties
described in the Risk Factors and in Management's Discussion and
Analysis of Financial Condition and Results of Operations sections
of our most recently filed Annual Report on Form 10-K and our
subsequently filed Quarterly Reports on Form 10-Q. 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.
- American Cancer Society. Survival rates for colorectal
cancer. https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed April 30, 2020.
- Piscitello A, Edwards DK. Estimating the screening-eligible
population size, aged 45 to 74, at average risk to develop
colorectal cancer in the United
States. Cancer Prev Res.
Published OnlineFirst February 6,
2020.
- Weiser E, et al. J Med Screen. 2020; In Press: DOI:
10.1177/0969141320903756
- Hassan C, et al. Aliment Pharmacol Ther.
2012;36(10):929-940.
- Ibid
- Joseph DA, King JB, Dowling NF, Thomas CC, Richardson
LC. Vital Signs: Colorectal Cancer Screening Test Use —
United States, 2018. MMWR Morb
Mortal Wkly Rep 2020; 69:253–259.
DOI: http://dx.doi.org/10.15585/mmwr.mm6910a1
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