SAN DIEGO, May 17, 2019 /PRNewswire/ -- New research
from Exact Sciences and Mayo Clinic demonstrates the ability of
Cologuard to both screen large patient populations and consistently
help detect colorectal cancers and pre-cancers regardless of lesion
location. The findings, presented at Digestive Disease Week (DDW)
2019, reinforce the role of Cologuard in improving colorectal
cancer screening rates and patient outcomes.
Despite recent efforts to positively impact colorectal cancer
screening rates in the US, one-in-three Americans ages 50 to 75 are
not up to date with recommended screening.i New research
suggests the Cologuard test can help screen more people. A review
of more than 365,000 Medicare orders from Exact Sciences
Laboratories, the sole-source lab for Cologuard, demonstrated high
Cologuard compliance ii (71.1%) in the Medicare
population. Further, more than nine-in-ten (90.7%) patients who
completed the test did so within 60 days of receiving the order
from their health care provider. During this window, the Exact
Sciences Laboratories Patient Navigation System, which includes
on-demand phone support, reminder phone calls, texts and emails, is
most actively engaged. These findings
(https://www.gastrojournal.org/article/S0016-5085(19)38398-2/fulltext)
demonstrate Cologuard test features, coupled with its nationwide
patient navigation system, can support high colorectal cancer
screening compliance rates in the Medicare population.
"Colorectal cancer is the second leading cause of cancer death
in the United States because
screening rates are too low," said Mark
Stenhouse, president of Cologuard. "These findings add to
the growing body of real-world evidence that show Cologuard—with
its high compliance and high sensitivity—can be part of the
solution for patients at average risk for colorectal cancer."
Additionally, new research continues to support the strength of
Cologuard in detecting right-sided polyps and cancers. In a
real-world analysis of data from Mayo Clinic, researchers found
(https://www.gastrojournal.org/article/S0016-5085(19)38402-1/fulltext)
that among patients with a positive Cologuard result, the large
majority went on to complete the recommended diagnostic
colonoscopy. Of the patients who were found to have colorectal
neoplasia at diagnostic colonoscopy, the proportion of right-sided
lesions was higher in those with a history of prior colonoscopy
compared to those who were new to screening, indicating that prior
screening may have missed these right-sided lesions.
"These data underscore the value of Cologuard in improving
colorectal cancer screening outcomes for average-risk adults,"
Stenhouse added.
Earlier detection impacts colorectal cancer outcomes. When
colorectal cancer is detected in Stage I, about 90 percent of
patients survive five years, and the removal of pre-cancerous
lesions can further prevent the disease from progressing. Only
about 11 percent of patients survive five years when the disease is
detected in Stage IV.iii
Since Cologuard received FDA approval in 2014, more than 160,000
healthcare providers have ordered Cologuard and more than 2.2
million Americans have been screened with Cologuard. Nearly half of
Cologuard users surveyed by Exact Sciences Laboratories, after
having been screened with Cologuard, self-reported that they had
not previously been screened for colorectal cancer. Based on
Cologuard's detection rate for early stage colorectal cancer and
pre-cancerous polyps, Exact Sciences estimates the test may have
helped detect as many as 10,000 early-stage cancers and
approximately 70,000 pre-cancerous polyps.iv
Additional abstracts by Exact Sciences' collaborators to be
presented during DDW 2019 include:
(https://www.gastrojournal.org/issue/S0016-5085(19)X6001-1)
- Colonoscopy in Community Practice Following Fecal DNA Testing
Among Patients in the New Hampshire Colonoscopy Registry
- Multi-target Stool DNA Testing Enriches Detection of Colorectal
Neoplasia by Colonoscopy but Yield is Influenced by Baseline Polyp
Detection Rates
- Multitarget Stool DNA Testing as Alternative for
Colonoscopy-Based Surveillance: An Interim Analysis
- Multi-Target Stool DNA Testing: Yield as a Function of Time
Since Last Colonoscopy
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 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 of either sex, 50 years or
older, who are at average risk for colorectal cancer. Cologuard is
not for everyone and is not a replacement for diagnostic
colonoscopy or surveillance colonoscopy in high-risk individuals,
including those with a history of colorectal cancer and advanced
adenoma, a family history of colorectal cancer, IBD or certain
hereditary syndromes. False positives and false negatives do occur.
Any positive test result should be followed by a diagnostic
colonoscopy. Following a negative result, patients should continue
participating in a screening program at an interval and with a
method appropriate for the individual patient. Cologuard
performance when used for repeat testing has not been evaluated or
established. Medicare and most major insurers cover Cologuard. For
more information about Cologuard, visit www.cologuardtest.com.
Rx Only.
About Exact Sciences Corp.
Exact Sciences Corp. is a
molecular diagnostics company focused on the early detection and
prevention of some of the deadliest forms of cancer. The company
has exclusive intellectual property protecting its non-invasive,
molecular screening technology for the detection of colorectal
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.
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 those sections.
Forward-looking statements, which are based on certain assumptions
and describe our future plans, strategies and expectations, can
generally be identified by the use of forward-looking terms such as
"believe," "expect," "may," "will," "should," "would," "could,"
"seek," "intend," "plan," "goal," "project," "estimate,"
"anticipate" or other comparable terms. All statements other than
statements of historical facts included in this news release
regarding our strategies, prospects, financial condition,
operations, costs, plans and objectives are forward-looking
statements. Examples of forward-looking statements include, among
others, statements we make regarding expected future operating
results, anticipated results of our sales and marketing efforts,
expectations concerning payer reimbursement and the anticipated
results of our product development efforts. Forward-looking
statements are neither historical facts nor assurances of future
performance. Instead, they are based only on our current beliefs,
expectations and assumptions regarding the future of our business,
future plans and strategies, projections, anticipated events and
trends, the economy and other future conditions. Because
forward-looking statements relate to the future, they are subject
to inherent uncertainties, risks and changes in circumstances that
are difficult to predict and many of which are outside of our
control. Our actual results and financial condition may differ
materially from those indicated in the forward-looking statements.
Therefore, you should not rely on any 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: our ability to successfully and profitably market our
products and services; the acceptance of our products and services
by patients and healthcare providers; our ability to meet demand
for our products and services; 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 from other cancer screening and
diagnostic products and services; the effects of the adoption,
modification or repeal of any law, rule, order, interpretation or
policy relating to the healthcare system, including without
limitation as a result of any judicial, executive or legislative
action; the effects of changes in pricing, coverage and
reimbursement for our products and services, including without
limitation as a result of the Protecting Access to Medicare Act of
2014; recommendations, guidelines and quality metrics issued by
various organizations such as the U.S. Preventive Services Task
Force, the American 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; our ability to effectively utilize strategic
partnerships, such as our Promotion Agreement with Pfizer, Inc.,
and acquisitions; our success establishing and maintaining
collaborative, licensing and supplier arrangements; our ability to
maintain regulatory approvals and comply with applicable
regulations; 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.
About Digestive Disease Week
Digestive Disease
Week® (DDW) is the largest international gathering of
physicians, researchers and academics in the fields of
gastroenterology, hepatology, endoscopy and gastrointestinal
surgery. Jointly sponsored by the American Association for the
Study of Liver Diseases (AASLD), the American Gastroenterological
Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW takes place May 18-21, 2019, at the San Diego Convention Center. The meeting
showcases more than 5,000 abstracts and hundreds of lectures on the
latest advances in GI research, medicine and technology. More
information can be found at www.ddw.org.
Media Contact:
Cara
Connelly
Exact Sciences Corp.
cconnelly@exactsciences.com
608-210-5735
Investor Contact:
Megan
Jones
Exact Sciences Corp.
meganjones@exactsciences.com
608-535-8815
i Centers for Disease Control and Prevention.
Vital signs: colorectal cancer tests save lives. Centers for
Disease Control and Prevention website.
http://www.cdc.gov/vitalsigns/colorectalcancerscreening. Updated
November 7, 2013. Accessed
January 17, 2019.
ii Compliance was defined as completion of the
mt-sDNA test (positive or negative result) within 365 days of the
order date
iii The J Natl Cancer Inst 2009; 101:1412-1422.
iv 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
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