EXACT Sciences Corporation (NASDAQ: EXAS) announced today that the Company's non-invasive, stool-based DNA (sDNA) technology is included in the updated guidelines for colorectal cancer screening released by the American Cancer Society's (ACS). The guidelines were developed by the ACS in collaboration with the U.S. Multi-Society Task Force on Colorectal Cancer (a group comprised of representatives from the American College of Gastroenterology, American Gastroenterological Association, and American Society for Gastrointestinal Endoscopy), and the American College of Radiology.
MARLBOROUGH, Mass. (Business Wire EON) March 6, 2008 --
EXACT Sciences Corporation (NASDAQ: EXAS) announced today that the
Company’s non-invasive, stool-based DNA (sDNA)
technology is included in the updated guidelines for colorectal cancer
screening released by the American Cancer Society’s
(ACS). The guidelines were developed by the ACS in collaboration with
the U.S. Multi-Society Task Force on Colorectal Cancer (a group
comprised of representatives from the American College of
Gastroenterology, American Gastroenterological Association, and American
Society for Gastrointestinal Endoscopy), and the American College of
Radiology.
“In addition to colonoscopy and other
previously recommended tests, two new options have been included in the
guidelines for colorectal cancer screening; stool DNA testing and CT
colonography,” said Dr. Sidney Winawer,
Attending Gastroenterologist and Paul Sherlock Chair in Medicine at
Memorial Sloan-Kettering Cancer Center. “We
hope that these two new options will encourage more people to come in to
be screened so that the death rates of this cancer can be further
reduced.”
EXACT Sciences developed its sDNA technology based on the groundbreaking
work of Drs. Bert Vogelstein, Kenneth Kinzler and colleagues at Johns
Hopkins University, who discovered how colorectal cancer develops at the
molecular level. Over time, cells lining the colon accumulate
alterations and mutations in their DNA. Pre-cancerous lesions, such as
adenomas, and colorectal cancers continuously shed cells into the stool.
The altered DNA from these cells is released as the cells breakdown in
the stool. EXACT’s stool-based DNA technology
was designed so that a stool sample could be collected in the privacy of
one’s home and shipped to a laboratory for
testing. The laboratory isolates and amplifies the DNA from the sample,
and analyzes it for DNA mutations and alterations that are known to be
associated with colorectal cancer.
“These updated guidelines are a strong
endorsement of sDNA technology for detecting colorectal cancer, and a
major step forward for the millions of Americans over the age of 50 who
have been unwilling or unable to use existing screening methods for
detecting colorectal cancer,” said Jeffrey
Luber, President of EXACT Sciences Corporation. “Because
sDNA technology is a completely non-invasive approach that does not
require bowel preparation, published studies demonstrate strong patient
preference and compliance with sDNA screening relative to other methods.
We believe that these benefits will facilitate more screening and lead
to more lives saved over time.”
"The colorectal cancer screening guidelines released by the American
Cancer Society are an important event in the battle against colon
cancer," said David King, President and CEO of Laboratory Corporation of
America, licensee of EXACT's stool-based DNA screening technologies. "We
applaud the committee's decision to include this important non-invasive
technology in the guidelines."
Colorectal cancer is the most deadly cancer among non-smoking men and
women in the United States, and the second most deadly cancer overall.
It is estimated that nearly 150,000 cases will be diagnosed and 50,000
deaths are anticipated in 2008 due to this disease.1
Despite the availability of colorectal cancer screening and diagnostic
tests for more than 20 years, the rate of early detection of colorectal
cancer remains low, and deaths remain high. It is estimated that roughly
one-third of colorectal cancer-related deaths could be saved if more
people underwent regular screening. Early diagnosis results in a greater
than 90 percent, five-year survival rate.
The new colorectal cancer screening guidelines are expected to appear in
the May/June issue of CA: A Cancer Journal for Clinicians and are
published early online in CA First Look at http://caonline.amcancersoc.org/.
They are also expected to be published in the upcoming issues of the
journals Gastroenterology and Radiology.
EXACT Sciences will hold a conference call to discuss the updated
national colorectal cancer screening guidelines, as well as other
business activities, including the Company’s
recent meeting with the U.S. Food and Drug Administration and current
regulatory strategy at 4:30pm ET today, March 6, 2008.
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Information for the call is as follows:
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Domestic callers: 800-706-7741
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International callers: 617-614-3471
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Participant Passcode: 73576907
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The conference call replay information is as follows:
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Domestic callers: 888-286-8010
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International callers: 617-801-6888
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Participant Passcode: 73080827
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A live webcast of the conference call can be accessed at www.exactsciences.com
through the Investor Relations link. The conference call and the webcast
are open to all interested parties. An archived version of the webcast
will be available at EXACT Sciences’ web
site, www.exactsciences.com,
through the Investor Relations link, for one month. A replay of the
conference call also will be available for 48 hours, beginning two hours
after the completion of the live call.
The webcast is also being distributed over CCBN’s
Investor Distribution Network to both institutional and individual
investors. Individual investors can listen to the call through CCBN’s
individual investor center at www.companyboardroom.com
or by visiting any of the investor sites in CCBN’s
Individual Investor Network. Institutional investors can access the call
via CCBN’s password-protected event
management site, StreetEvents (www.streetevents.com).
About EXACT Sciences Corporation
EXACT Sciences Corporation uses applied genomics to develop effective,
patient-friendly screening technologies for use in the detection of
cancer. Certain of its technologies have been licensed to Laboratory
Corporation of America Holdings® (LabCorp®)
for a stool-based DNA assay developed by LabCorp for colorectal cancer
screening in the average-risk population and marketed by LabCorp under
the name PreGen-Plus™. EXACT Sciences
believes its genomics-based technologies will help enable earlier
detection of colorectal cancer so that more people can be effectively
treated. EXACT Sciences is based in Marlborough, Mass. PreGen-Plus, the
non-invasive colorectal cancer screening testing service offered by
LabCorp, has not been approved or cleared by the U.S. Food & Drug
Administration.
Certain statements made in this press release that are not based on
historical information are express or implied forward-looking statements
relating to, among other things, EXACT Sciences' expectations
concerning, among other things, the effectiveness of its colorectal
cancer screening technologies and their ability to increase patient
screening rates, the publication of the updated screening guidelines and
similar matters. These statements are neither promises nor guarantees,
but are subject to a variety of risks and uncertainties, many of which
are beyond EXACT Sciences' control, and which could cause actual results
to differ materially from those contemplated in these forward-looking
statements. In particular, the risks and uncertainties include, among
other things, the clinical performance and market acceptance of its
technologies; the reproducibility of its research results in subsequent
studies and in clinical practice; sufficient investment in the sales and
marketing of tests using EXACT Sciences' technologies; the success of
its strategic relationship with LabCorp; the ability to convince
Medicare and other third-party payors to provide adequate reimbursement
for EXACT Sciences' current and future technologies; the ability to
convince medical practitioners to order tests using EXACT Sciences'
technologies; the ability to increase the performance of sDNA testing;
the ability of EXACT Sciences or LabCorp to lower the cost of the sDNA
testing through automating and simplifying key operational processes;
the number of people who decide to be screened for colorectal cancer
using EXACT Sciences' technologies; and the ability to comply with
federal and state statutes and regulations relating to EXACT Sciences'
products and services, including FDA requirements. Existing and
prospective investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date hereof.
EXACT Sciences undertakes no obligation to update or revise the
information contained in this press release, whether as a result of new
information, future events or circumstances or otherwise. For additional
disclosure regarding these and other risks faced by EXACT Sciences, see
the disclosure contained in EXACT Sciences' public filings with the
Securities and Exchange Commission including, without limitation, its
most recent Annual Report on Form 10-K and subsequent Quarterly Reports
on Form 10-Q.
1 American Cancer Society, Facts & Figures, 2008
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