Exact Sciences Corp. (Nasdaq: EXAS) this afternoon presented a scientific poster at the International Frontiers in Cancer Prevention Research, a meeting of the American Association for Cancer Research. A copy of the poster, titled “An Optimized Molecular Stool Test for Colorectal Cancer Screening: Evaluation of an Automated Analytic Platform and Logistic Algorithm,” can be found at investor.exactsciences.com.
The study that generated the data presented today included 1,003 patients at 36 study centers. Among the study population, there were 93 cases of colorectal cancer, 114 cases of advanced pre-cancers and 796 controls.
“We are very pleased with the performance of our noninvasive, stool DNA-based colorectal cancer screening test in this latest validation study,” said Kevin T. Conroy, president and chief executive of Exact Sciences. “At a nominal specificity of 90 percent, the test achieved sensitivity of 98 percent in the detection of cancer and 83 percent in the detection of high-grade dysplasia cases, the majority of which progress to cancer. The test demonstrated 57 percent sensitivity in the detection of advanced pre-cancers equal to or larger than 1 centimeter. The test’s sensitivity increased with the pre-cancers’ size, rising to 83 percent for pre-cancers larger than 3 centimeters. The study was conducted using the automation platform that will be used in the DeeP-C pivotal study and will be part of our FDA submission.”
About Exact Sciences Corp.Exact Sciences Corp. is a molecular diagnostics company focused on colorectal cancer. The company has developed a proprietary, multi-target, stool-DNA colorectal cancer screening test that runs on an automated testing platform. It is conducting a clinical trial called the DeeP-C study that has enrolled more than 10,000 patients and includes both the test and the automation platform. 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, anticipated results of our pivotal clinical trial, expectations concerning our ability to secure FDA approval of our Cologuard test, 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.