MADISON, Wis., April 2, 2020 /PRNewswire/ -- Exact Sciences
Corp. (NASDAQ: EXAS) today announced it would be devoting
significant patient education resources toward the ability to
request Cologuard® online through a telehealth provider. During the
COVID-19 pandemic, people are staying home to avoid spreading the
virus. Telehealth offers a way to screen more people at home, even
during a public health crisis.
"Cancer doesn't stop for anything. As the country faces a
pandemic, we are letting people know they can request Cologuard
online from a health care provider, without an office visit," said
Kevin Conroy, Exact Sciences
chairman and CEO. "While Americans are at home trying to prevent
the spread of COVID-19 in their communities, they can address
another pressing public health issue and get screened for
colorectal cancer."
Colorectal cancer, the second leading cancer killer in the
U.S.,1 is more treatable when detected early, making
timely screening essential. 2 Despite this, an estimated
53,000 Americans will die this year from colorectal
cancer.1 As the only FDA-approved stool DNA test for
colorectal cancer, Cologuard found 92% of all colorectal
cancers,3 including 94% in stages I and II4
in a large clinical study of patients 50 and older. The United
States Preventive Services Task Force (USPSTF) recommends Cologuard
as a screening test for average risk patients.5 Patients
can use Cologuard without any preparation or changes in diet and
medication. The Cologuard collection kit is delivered to a
patient's door, and home pick-up can be scheduled by calling Exact
Sciences Laboratories' 24/7 Customer Care Center at 1-844-870-8870.
Test results are provided to the ordering physician in
approximately 14 days.
People can visit Cologuardtest.com to learn more about
telehealth options for their screening needs, including how
telehealth providers can review patient information and risk
factors and, if appropriate, prescribe Cologuard. Cologuard is
intended to screen adults 45 years of age or older, who are at
average risk for colorectal cancer. It is not a replacement
for colonoscopy in high-risk individuals. Cologuard is
available by prescription only.
Any positive Cologuard test result should be referred for a
diagnostic colonoscopy. Recognizing it may be challenging to
schedule a follow-up colonoscopy immediately during the COVID-19
pandemic, Exact Sciences is actively exploring ways we may be able
to support patients as they navigate those next steps.
Exact Sciences' testing labs remain operational at this time.
Business continuity plans are in place at all sites to help sustain
operations and ensure continuity of service for patients during
this unprecedented time. Customer Care teams are available 24/7 to
help patients complete their Cologuard collection kit and schedule
an at-home pick-up by calling 1-844-870-8870. Cologuard
kits can also be dropped at any UPS location.
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 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, expectations, 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, 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 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: uncertainties associated with COVID-19, including its
possible effects on our operations and the demand for our products
and services; our ability to efficiently and flexibly manage our
business amid uncertainties related to COVID-19; 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 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, 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 Society of Clinical Oncology, 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 and
assess potential market opportunities; our ability to effectively
utilize strategic partnerships, such as through 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; our ability to manage an
international business and our expectations regarding our
international expansion and opportunities; the potential effects of
foreign currency exchange rate fluctuations and our efforts to
hedge such effects; the possibility that the anticipated benefits
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.
References:
- Siegel RL, Miller KD, Jemal A.
Cancer statistics, 2020. CA Cancer J Clin.
2020;70(1):7-30.
- American Cancer Society. Survival rates for colorectal cancer.
https://www.cancer.org/cancer/colon-rectal-cancer/detection-diagnosis-staging/survival-rates.html.
Accessed March 24, 2020.
- 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.
- Ahlquist DA. Multi-target stool DNA test: a new high bar for
noninvasive screening. Dig Dis Sci. 2015;60(3):623-633.
- Bibbins‐Domingo K, Grossman DC, Curry SJ, et al. Screening for
Colorectal Cancer: US Preventive Services Task Force Recommendation
Statement. JAMA. 2016;315:2564‐2575.
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