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Exact Sciences’ (EXAS) Methylation Detection Technology Achieves 100 Percent Sensitivity, Specificity

ANAHEIM, Calif.–(BUSINESS WIRE)–Exact Sciences Corp. (Nasdaq: EXASNews) today announced that data being presented this afternoon at the annual meeting of the American Association of Clinical Chemistry (AACC) demonstrates that its methylation specific technology, using a combination of DNA methylation markers, detected 100 percent of colorectal cancers and precancers at a specificity cutoff of 100 percent in a preliminary study with colorectal tissue.

The study data also showed that the methylation specific technology was able to detect fewer than 10 copies of methylated DNA. The technology also demonstrated the ability to discriminate 10 copies of methylated DNA target in an unmethylated target population of 100,000 copies.

“The data being presented today at AACC illustrates the groundbreaking approach Exact Sciences is taking to the detection of both colorectal cancers and precancers,” said Kevin T. Conroy, president and chief executive of Exact Sciences. “We believe our study is the first time that any set of markers has achieved 100 percent discrimination of both colorectal cancers and precancers from normal tissue. While we believe the performance of these markers will be diminished in stool samples, the 100 percent sensitivity and specificity they demonstrated in tissue samples gives us confidence about achieving our goal of greater than 85 percent and 50 percent cancer and precancer sensitivity, respectively, in our upcoming validation study, which will include approximately 1,650 stool samples.”

DNA methylation regulates gene expression, the process that converts the information in DNA into proteins. Scientific studies have shown that methylation markers are clinically relevant for the detection of colorectal cancers and precancers. Methylation markers are typically present more frequently than individual DNA mutation markers in colorectal cancers and precancers and, as a result, fewer methylation markers are required to detect them.

The data is being presented at the AACC meeting in a poster titled “Sensitive Quantification of Methylated Markers with a Novel Methylation Specific Technology.” The study was a collaboration of Exact Sciences and Mayo Clinic.

About Exact Sciences Corp.

Exact Sciences Corp. is a molecular diagnostics company focused on colorectal cancer. The company has exclusive intellectual property protecting its non-invasive, molecular screening 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

Certain statements made in this press 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 press release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, 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 of 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.

Wednesday, July 28th, 2010 Uncategorized
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