EXHIBIT 99.1
PREGEN-PLUS(TM) FOUR TIMES MORE SENSITIVE THAN FOBT
IN EXACT SCIENCES' MULTI-CENTER STUDY
Results presented at satellite symposium at American College of Gastroenterology
meeting
MARLBOROUGH, MASS. - (OCTOBER 11, 2003) - EXACT Sciences Corporation
(NASDAQ:EXAS) announced today that its multi-center study of PreGen-Plus(TM)
versus the fecal occult blood test (FOBT) achieved its primary endpoint of
superiority with high statistical significance (p less than 0.001). The data
was presented at a satellite symposium at the American College of
Gastroenterology 2003 Annual Conference. PreGen-Plus, EXACT Sciences'
DNA-based stool test, was four times more sensitive than the most widely used
fecal occult blood test (Hemoccult(R) II) for the detection of colon cancer
in an average-risk, asymptomatic population. Data in the population studied
indicated a point sensitivity for FOBT of 13 percent and a point sensitivity
for PreGen-Plus of 52 percent. Additionally, in the earliest stage, which are
the most curable cancers (Dukes' stages A and B), PreGen-Plus(TM)
demonstrated a point sensitivity of 57 percent versus a point sensitivity for
FOBT of 13 percent.
Data from the study also indicated that PreGen-Plus was substantially more
sensitive than FOBT in detecting advanced adenomas exhibiting high-grade
dysplasia/carcinoma in situ, the lesions believed to be the most likely to
progress to invasive cancer. There was no difference in specificity between the
two tests, with both tests exhibiting a specificity of approximately 95 percent
in this study, which is within the expected range.
The version of PreGen-Plus employed in the study is the original, bead-based
technology. The version of PreGen-Plus that is commercially available through
Laboratory Corporation of America(R) Holdings incorporates several technology
improvements, which the Company believes increase the performance
characteristics of the assay. No additional data from the multi-center study
will be provided prior to the publication of the complete data set in a
peer-reviewed journal, which the Company plans to submit as soon as the data
analysis is completed.
"This study of PreGen-Plus in an average-risk, asymptomatic population
represents a significant achievement for EXACT Sciences, and for the patients
and physicians who participated in the study," said Dr. Michael Ross, EXACT
Sciences' Vice President of Clinical Affairs. "Given the outstanding performance
of PreGen-Plus compared to FOBT in this study, it is clear that physicians now
have a new non-invasive colorectal cancer screening option with superior
sensitivity to aid in the early detection of colorectal cancer and the
prevention of colorectal cancer mortality."
"We are delighted with the results of this study," stated Don Hardison, EXACT
Sciences' President and CEO. "The clear superiority of PreGen-Plus versus FOBT
in this study, in conjunction with the patient preference data we have gathered,
establishes PreGen-Plus as the best non-invasive option available to physicians
and their patients. We believe that the large body of clinical data on
PreGen-Plus provides ample support both for the inclusion of PreGen-Plus in
colorectal cancer screening guidelines and for payors to write positive
reimbursement policy decisions on PreGen-Plus. We firmly believe that
PreGen-Plus will become an important tool in the fight against colorectal
cancer, with the ultimate result of reducing the mortality from this terrible
disease."
CONFERENCE CALL INFORMATION
EXACT Sciences will host a conference call regarding the data presentation on
Monday, October 13, 2003 at 9:00 a.m. EDT. A live Webcast of the conference
call, as well as an archived version following the completion of the call, will
be available at www.exactsciences.com by clicking on the Investor Relations
link. The conference call and Webcast are open to all interested parties.
Information for the call is as follows:
Domestic callers: 877-809-1575
International callers: 706-679-5918
PIN#: 3234266
A replay of the conference call will be available for 48 hours beginning two
hours after the live call ends. Information for the replay is as follows:
Domestic callers: 800-642-1687
International callers: 706-645-9291
PIN #: 3234266
ABOUT EXACT SCIENCES CORPORATION
EXACT Sciences Corporation is a pioneer in applying genomics to solve large
clinical needs. Its DNA-based assay, PreGen-Plus(TM), is intended for the early
detection of colorectal cancer in the average-risk population. The Company also
has developed PreGen-26(TM), intended to detect colorectal cancer in a high-risk
group of patients. Colorectal cancer, which is the most deadly cancer among
non-smokers, is curable if detected early. Despite the availability of
colorectal cancer screening and diagnostic tests for more than 20 years,
however, the rate of early detection of colorectal cancer remains low, and
deaths from colorectal cancer remain high. EXACT Sciences believes its
genomics-based technologies will enable early detection of colorectal cancer so
that more people can be effectively treated. Founded in 1995, EXACT Sciences is
based in Marlborough, Mass. Detailed information on EXACT Sciences and
PreGen-Plus can be found on the World Wide Web at www.exactsciences.com and
www.pregenplus.com.
Certain statements made in this press release that are not based on historical
information are forward-looking statements which are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995. This
press release contains express or implied forward-looking statements relating
to, among other things, EXACT Sciences' expectations concerning its future
revenues and expenses, its business outlook and business momentum, its clinical
trials, the commercial launch of its technologies, and the effectiveness and
market acceptance of its technologies. 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, 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
inability to convince Medicare and other third-party payors to provide adequate
reimbursement for EXACT Sciences' products and services; the failure to convince
medical practitioners to order tests using EXACT Sciences' technologies; the
lack of market acceptance of PreGen-26, PreGen-Plus, and other PreGen
technologies to screen for colorectal cancer; the inability of EXACT Sciences to
control its commercial partners' operations, performance or sales performance,
including sales of products utilizing EXACT Sciences' technologies; the
inability of EXACT Sciences' commercial partners to create a market for and sell
products using EXACT Sciences' technologies; the loss of support of key
scientific collaborators; the failure to comply with federal and state statutes
and regulations relating to EXACT Sciences' products and services, including FDA
requirements, and relating to the operation of EXACT Sciences' laboratory,
including the Clinical Laboratory Improvement Amendments; competition; and the
inability to protect EXACT Sciences' intellectual property and the cost of
enforcing or defending EXACT Sciences in litigation relating to intellectual
property rights. 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 SEC filings.
CONTACT:
Media:
Fleishman-Hillard
Peggy Kochenbach or Kate Jennings, 617/267-8223
kochenbp@fleishman.com
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jenningk@fleishman.com
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or
Investor Relations and Corporate Communications:
EXACT Sciences
Amy Hedison, 508/683-1252
ahedison@exactsciences.com
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