Exact Sciences Reports Positive Results for Colorectal Cancer Screening Test

Data from Preliminary Study Meets Goals for Cancer Detection, Exceeds for Pre-Cancer Detection

MADISON, Wis.--(BUSINESS WIRE)-- Exact Sciences (Nasdaq: EXAS) today presented data showing that its non-invasive CologuardTM stool-based (sDNA) screening test detected 64 percent of colorectal pre-cancers and 85 percent of cancers. The study was conducted in collaboration with Mayo Clinic and examined more than 1,100 patient samples. Results were presented at the 2010 Special Conference for Colorectal Cancer: Biology to Therapy held by the American Association for Cancer Research in Philadelphia, PA.

Colorectal cancer is the second leading cancer killer in the United States. It often is considered the most preventable, yet least prevented cancer. Colorectal cancer is highly treatable if found early, but 40 percent of adults age 50 and older have not been screened as recommended.

“This is the first study of an sDNA test to show such promising results in detecting colorectal pre-cancer,” said lead investigator David A. Ahlquist, M.D., Mayo Clinic, Rochester, Minn. “Colorectal cancer is a treatable disease if caught early, and this test shows great promise as a potential addition to other available screening tools.”

The latest American Cancer Society colorectal cancer screening guidelines include the sDNA form of testing as a recommended screening option. The Cologuard sDNA test works by detecting specific altered DNA sequences in cells that are shed into the stool from pre-cancerous or cancerous polyps. If a DNA abnormality is identified from a patient’s sample, a colonoscopy is required to confirm the results.

Findings from the more than 1,100-patient study showed that Cologuard detected 64 percent of adenomas, or polyps, greater than 1 centimeter (cm) and 85 percent of cancer, at a specificity of 88 percent. Polyps over 1 cm are considered the pre-cancers most likely to progress to cancer. Detection rates did not vary by patients’ age or sex, or by cancer location.

“We are excited about these encouraging results for Cologuard, which may offer an important step in the early detection of this terrible disease,” said Kevin T. Conroy, president and chief executive of Exact Sciences.

Cologuard is an investigational device and is not available for sale in the United States. The company plans to begin clinical trials next year.

About the Study

Exact Sciences’ novel sDNA test approach incorporates direct capture from stool supernatant and QuARTS™ (Quantitative Allele-specific Real-time Target and Signal amplification) assay technology. This technology is designed to significantly increase analytic sensitivity compared to first generation sDNA assays.

These data represent an early evaluation of Cologuard in large specificity, training and test sets of 1,187 stool samples from well-characterized patients with and without colorectal neoplasia. By using a combination of methylation, mutation, and hemoglobin markers, the test set and the training set combined achieved sensitivities of 85.3 percent for detection of colorectal cancer and 63.8 percent for adenomas greater than 1 cm at a specificity of 88 percent. Polyps greater than 1 cm are considered the pre-cancers most likely to progress to cancer. Detection rates did not vary by age, sex, or cancer site. This study successfully showed high sensitivity for the detection of colorectal cancer and is the first non-invasive test to show potential to detect pre-cancerous adenomas.

There will be an investor call and webcast with additional details on this study today at 3:00 pm EDT. On the call, Dr. David Ahlquist and Dr. Graham Lidgard, chief scientific officer of Exact Sciences, will describe the results of the validation study, including details of both the training and test sets. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-212-6082 and international callers should dial 707-287-9332. The access code for both domestic and international callers is 15683774. A replay of the conference call will be available at the company’s website. The conference call, webcast and replay are open to all interested parties.

About Colorectal Cancer

Colorectal cancer is the second leading cancer killer in the United States. The National Cancer Institute estimates there will be about 142,000 new cases of colorectal cancer diagnosed in 2010 and that more than 51,000 people will die from colon and rectal cancer this year. The American Cancer Society recommends that all Americans start getting tested for the disease at age 50. However, many patients do not comply fully with current screening recommendations. In fact, 60 percent of patients today are diagnosed with colorectal cancer in the late stages, primarily because of poor screening compliance.

Collaboration with Mayo Clinic

In June 2009, Exact Sciences entered into a collaboration and license agreement with Mayo Clinic. Under the license agreement, Exact Sciences secured exclusive rights to intellectual property developed by David Ahlquist, M.D., Mayo Clinic. The licensed patents cover advances in sample processing, analytical testing and data analysis associated with non-invasive, stool-based DNA screening for colorectal cancer. As part of the agreement, Exact Sciences will make up-front, milestone and royalty payments to Mayo Clinic and Dr. Ahlquist, and will provide funding for future work in Dr. Ahlquist’s lab. Exact Sciences and Mayo Clinic also entered into a broad research and development relationship with Dr. Ahlquist’s laboratory. The relationship provides Exact Sciences with an experienced research and development team that is focused on the company’s colorectal screening test. Exact Sciences retains exclusive rights to commercialize the breakthroughs that result from this collaboration.

About Exact Sciences

Exact Sciences 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 (sDNA) 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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