Top-Line Data Show Exact Sciences' Cologuard Test Demonstrates 92 Percent Sensitivity in the Detection of Colorectal Cancer
All endpoints achieved in 10,000-patient trial of non-invasive,
convenient DNA-based screening test for colorectal cancer and
MADISON, Wis.--(BUSINESS WIRE)--
Exact Sciences Corp. (Nasdaq: EXAS) today announced that preliminary
analysis shows that the company's Cologuard colorectal cancer screening
test met or exceeded all primary and secondary endpoints of its recently
completed DeeP-C pivotal clinical trial. The clinical trial evaluated
the test's use for the detection of colorectal cancer and pre-cancerous
Senior Research Associate Tanya Quint loads one of the instruments used to run Exact Sciences' Cologuard test at the company's headquarters in Madison, Wis. (Photo: Business Wire)
Preliminary, top-line data show that Cologuard demonstrated 92 percent
sensitivity for the detection of colorectal cancer and 42 percent
sensitivity for the detection of pre-cancerous polyps, including 66
percent sensitivity for polyps equal to or greater than 2 centimeters.
The test achieved a specificity of 87 percent during the trial.
Sensitivity measures a test's ability to correctly identify positive
results. It is the percentage of patients who were determined by
colonoscopy to have pre-cancerous polyps or cancer who had a positive
Cologuard test result. Specificity measures a test's ability to
correctly identify negative results. It is the percentage of patients
who were determined by colonoscopy not to have pre-cancerous polyps or
cancer who had a negative Cologuard test result.
According to the Journal of the National Cancer Institute,
colorectal cancer is often considered the most preventable, yet least
prevented cancer. But nearly 50 percent of those age 50 and older have
not been screened as recommended. As a result, colorectal cancer is the
second leading cause of cancer death in the United States.
The company's pivotal DeeP-C trial included 10,000 patients between the
ages of 50 and 84 who were at average risk for colorectal cancer.
Enrollment was conducted at 90 sites to gain a broad demographic
sampling of patients. The study is one of the most extensive colorectal
cancer screening studies ever conducted in the United States. It
compared the performance of the Cologuard test to colonoscopy and fecal
immunochemical testing or FIT.
"The DeeP-C trial evaluated Cologuard's ability to detect both
pre-cancerous polyps and cancer in a large, average-risk patient
population," said principal study investigator Thomas F. Imperiale,
M.D., professor of medicine, associate director for research for the
division of gastroenterology at Indiana University School of Medicine
and a member of the IU Simon Cancer Center. "There is a significant
unmet clinical need for an accurate, convenient, non-invasive colorectal
cancer screening test. The data from the DeeP-C trial are very
promising. Cologuard may well be a future solution for identifying slow
growing polyps much before they develop into cancer."
"We are extremely pleased with these results, which we believe strongly
support the power and potential clinical use of the Cologuard screening
test," said Kevin T. Conroy, president and chief executive of Exact
Sciences. "We believe our test could become a great tool in the fight
against this terrible disease."
Exact Sciences will submit data from the DeeP-C study to the U.S. Food
and Drug Administration as part of its pre-market approval (PMA)
submission. Later this year, the company also will submit the study's
complete data set for publication in a peer-reviewed journal,
presentation at a major medical meeting or both.
The DeeP-C clinical trial achieved all of its endpoints. The co-primary
endpoints for the Deep-C study were the sensitivity and specificity of
the Cologuard screening test for colorectal adenocarcinoma. The trial
included two sets of co-secondary endpoints. The first included
sensitivity and specificity of the test for advanced adenomas. The
second included non-inferiority of Cologuard to FIT for cancer
sensitivity and superiority to FIT for advanced adenoma sensitivity.
Each patient result from the Cologuard test was compared to the
patient's colonoscopy result and the histopathologic diagnosis of any
lesions that were discovered during colonoscopy and biopsied. The study
population included 64 cancer patients and 752 patients with
Exact Sciences' Cologuard screening test is designed to detect specific
changes in a patient's DNA that appear in the stool and often indicate
the presence of colorectal cancer or the pre-cancerous polyps most
likely to develop into it. The test also identifies the presence of
blood in the stool, another indicator of possible colorectal cancer. The
latest American Cancer Society colorectal cancer screening guidelines
include stool-based DNA testing as a recommended screening option.
The Exact Sciences' screening test is an investigational device and is
not available for sale in the United States. The scientific information
discussed in this news release related to our Cologuard test is
preliminary and investigative, pending additional analysis by the
company and review by the FDA.
Deep-C Pivotal Clinical Trial Results Webcast & Conference
Company management will host a webcast and conference call on Thursday,
April 18, 2013, at 7:30 a.m. ET to discuss the preliminary, top-line
results of its DeeP-C clinical trail. The webcast will be available at www.exactsciences.com.
Domestic callers should dial 877-212-6082 and international callers
should dial 707-287-9332. An archive of the webcast and a replay of the
conference call will be available at www.exactsciences.com
or by calling 855-859-2056 domestically or 404-537-3406 internationally.
The access code for the conference call and replay is 45786044. The
conference call, webcast and replay are open to all interested parties.
About Exact Sciences Corp.
Exact Sciences Corp. is a molecular diagnostics company focused on the
early detection of colorectal cancer. The company has exclusive
intellectual property protecting its convenient, non-invasive
stool-based DNA technology for the detection of colorectal cancer.
Stool-based DNA technology is included in the colorectal cancer
screening guidelines of the American Cancer Society and the U.S.
Multi-Society Task Force on Colorectal Cancer. For more information,
please visit the company's website at www.exactsciences.com.
Certain statements made in this news release contain forward-looking
statements within the meaning of Section 27A of the Securities Act of
1933, as amended, and Section 21E of the Securities and 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," "could," "seek," "intend," "plan," "estimate," "anticipate" or
other comparable terms. Forward-looking statements in this news
release may address the following subjects among others: statements
regarding the sufficiency of our capital resources, expected operating
losses, timing and anticipated results of our pivotal clinical trial and
our related FDA submissions, estimated markets for our products and
expected revenues, expected license fee revenues, expected research and
development expenses, expected general and administrative expenses and
our expectations concerning our business strategy. Forward-looking
statements involve inherent risks and uncertainties which could cause
actual results to differ materially from those in the forward-looking
statements, as a result of various factors including those 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
urge you to consider those risks and uncertainties in evaluating our
forward-looking statements. We caution readers not to place undue
reliance upon any such forward-looking statements, which speak only as
of the date made. Except as otherwise required by the federal
securities laws, we disclaim any obligation or undertaking to publicly
release any updates or revisions to any forward-looking statement
contained herein (or elsewhere) to reflect any change in our
expectations with regard thereto or any change in events, conditions or
circumstances on which any such statement is based.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20130418005463/en/
Corporate Communications Contact:
Exact Sciences Corp.
Jane Hauser, 781-684-0770
Source: Exact Sciences Corp.
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