MARLBOROUGH, Mass.--(BUSINESS WIRE)--Oct. 16, 2007--EXACT Sciences
Corporation (NASDAQ: EXAS) announced today that it has received a
Warning Letter from the Food and Drug Administration's (FDA) Office of
In Vitro Diagnostic Device Evaluation and Safety regarding regulatory
matters related to its DNA technology for colorectal cancer screening.
According to the letter, the FDA believes that the PreGen-Plus(TM)
assay is a medical device requiring premarket approval or clearance.
"Having spoken with the FDA regarding the letter, we are committed
to working collaboratively with them to pursue the appropriate filing
strategy for our DNA colorectal cancer screening technology," said
Jeffrey R. Luber, President of EXACT Sciences Corporation. "We have a
meeting scheduled with the FDA in the coming weeks and intend to file
a 510(k) application with the FDA as soon as possible to resolve these
issues. A potential regulatory filing for our patent-protected
technology had already been a long-term strategy for EXACT and we will
now be accelerating these activities."
The Company expects that the letter will be publicly available
within a few days on the FDA's website at
EXACT will host a FDA regulatory update call regarding its
stool-based DNA technology on Wednesday, October 17, 2007 at 8:30 a.m.
Information for the October 17, 2007 call is as follows:
Domestic callers: 866-825-3354
International callers: 617-213-8063
Participant Passcode: 67908163
The conference call replay information is as follows:
Domestic callers: 888-286-8010
International callers: 617-801-6888
Participant Passcode: 83488659
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 An
archived version of the Webcast will be available at EXACT Sciences'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
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).
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(R) (LabCorp(R)) 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(TM). Colorectal cancer, which is the most deadly
cancer among non-smokers, is generally curable if detected early.
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 from colorectal cancer
remain high. 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 regulatory strategy
for its DNA technology and management's plans, objectives and
strategies. 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; the ability of EXACT
Sciences to comply with federal and state statutes and regulations
relating to EXACT Sciences' products and services, including FDA
requirements; the inclusion of fecal DNA screening in colorectal
cancer screening guidelines; 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'
technologies; the ability to increase the performance of the
PreGen-Plus test; the ability of EXACT Sciences or LabCorp to lower
the cost of the PreGen-Plus test through automating and simplifying
key operational processes; competition; the possibility that other
companies will develop and market novel or improved methods for
detecting colorectal cancer; and the ability to raise additional
capital on acceptable terms. 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 the 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 filed with the SEC.
CONTACT: EXACT Sciences Corporation
Jeffrey Luber, 508-683-1211
SOURCE: EXACT Sciences Corporation