Healthcare Industry News:  colorectal cancer 

Diagnostics Gastroenterology Oncology

 News Release - August 8, 2008

EXACT Sciences Announces Next Generation Stool-based DNA Technology Study Results of 92% for Colorectal Cancer Detection

Head-to-Head Comparison Found Stool Outperformed Blood-Plasma DNA Testing in Published Study, Particularly for Early Stage Cancers

MARLBOROUGH, Mass.--(HSMN NewsFeed)--EXACT Sciences Corporation (NASDAQ: EXAS ) today announced the published results of a study in which stool and blood plasma were assessed, in a head-to-head comparison, for the detection of colorectal cancer (CRC). Using an improved BEAMing DNA detection technology from Johns Hopkins University, study results demonstrated 92 percent sensitivity for detecting CRC in stool samples. Importantly, results showed that, using this BEAMing technology, stool-based DNA testing outperformed blood plasma testing, especially for the detection of early stage CRCs. EXACT Sciences has exclusive rights to the Johns Hopkins University BEAMing technology for use in a next generation stool-based DNA (sDNA) detection technology for CRC.

In the study, a total of 25 stool DNA samples from colorectal cancer patients were analyzed and a next generation sDNA technology correctly identified 23 (92%) of the cancers. In the 16 of 25 cases where there were paired stool and plasma DNA samples, the sDNA technology detected mutated DNA in stool in 14 cases (88%) while only 8 (50%) corresponding plasma DNA samples had detectable levels of mutated DNA. Further, when late-stage disease (Stage IV) is removed from the total, non-invasive sDNA performance remained at 86% (12/14) while plasma DNA performance fell to 43% (6/14). The results of the study, Analysis of Mutations in DNA Isolated from Plasma and Stool of colorectal cancer Patients, were published in the August journal of Gastroenterology.

“We are very excited by these latest results as they underscore the early detection power that is achievable when combining advanced detection techniques with a DNA target-rich environment like stool,” commented Jeffrey R. Luber, EXACT Sciences’ President and Chief Executive Officer. “Although this technology is still at the very early stages of development, the results of this latest study suggest that stool, which is in immediate contact with the colorectal cancers and polyps, is the more reliable and robust source of mutated DNA when compared to blood plasma for detecting early stage colorectal cancer—an essential characteristic for a mass screening test.”

About BEAMing

BEAMing is the name of an assay technology which incorporates the use of “Beads, Emulsion, Amplification, and Magnetism”. The technology is a useful method for performing single-molecule analysis of DNA or “Digital PCR” that has been demonstrated to provide a high level of sensitivity for the detection of mutations or deletions in gene sequences of interest.

EXACT Sciences Corporation

EXACT Sciences Corporation uses applied genomics to develop patient-friendly screening technologies for use in the detection of cancer. EXACT maintains an exclusive license agreement in the United States and Canada with Laboratory Corporation of America® Holdings (LabCorp®) allowing LabCorp to offer a laboratory-developed testing service based on certain of EXACT Sciences’ intellectual property. EXACT continues to retain rights for the development of any U.S. Food and Drug Administration approved in vitro diagnostic kit, and rights to license its technologies outside of the United States and Canada. EXACT Sciences' stool-based DNA technology is included in the colorectal cancer screening guidelines of the American Cancer Society, the U.S. Multi-Society Task Force on colorectal cancer (a group comprised of representatives from the American College of Gastroenterology, American Gastroenterological Association, American Society for Gastrointestinal Endoscopy and the American College of Physicians), and the American College of Radiology. EXACT Sciences is based in Marlborough, Mass.

Certain statements made in this press release that are not based on historical information are express or implied forward-looking statements relating to, among other things, EXACT Sciences' expectations concerning the performance of future versions of its technologies and similar matters. These statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond EXACT Sciences' control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other things, EXACT Sciences' ability to secure FDA approval or clearance for any of its products; changes in FDA guidance or policy; the ability to attract prospective collaborators or other parties to enter into a collaboration, acquisition or other strategic transaction with EXACT; the ability to raise additional capital on acceptable terms; the clinical performance and market acceptance of its technologies; the reproducibility of its research results in subsequent studies and in clinical practice; sufficient investment in the sales and marketing of EXACT Sciences' technologies; the success of its strategic relationship with LabCorp; EXACT Sciences' ability to license certain technologies or obtain raw materials for its technologies; the ability to convince Medicare and other third-party payors to provide adequate reimbursement for EXACT Sciences' technologies; the ability to convince medical practitioners to order tests using EXACT Sciences' technologies; the ability to increase the performance its technologies; the ability of EXACT Sciences or LabCorp to lower the cost of stool-based DNA screening technologies through automating and simplifying key operational processes; the number of people who decide to be screened for colorectal cancer using EXACT Sciences' technologies; competition; the ability to protect EXACT Sciences' intellectual property and the cost of enforcing or defending EXACT Sciences in litigation relating to intellectual property rights; and the possibility that other companies will develop and market novel or improved methods for detecting colorectal cancer. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. EXACT Sciences undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. For additional disclosure regarding these and other risks faced by EXACT Sciences, see the disclosure contained in EXACT Sciences' public filings with the Securities and Exchange Commission including, without limitation, its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC.


Source: EXACT Sciences

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