Exact Sciences' Methylation Detection Technology Achieves 100 Percent Sensitivity, Specificity
ANAHEIM, Calif., Jul 28, 2010 (BUSINESS WIRE) -- Exact Sciences Corp. (Nasdaq: EXAS) 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 www.exactsciences.com.
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SOURCE: Exact Sciences Corp.
Maneesh K. Arora
Chief Financial Officer, Exact Sciences Corp.