CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company performing DNA-based testing services for developmental disorders and cancer diagnostics, today announced that a pair of studies published in a leading journal favor chromosomal microarray analysis (CMA) over traditional karyotyping for genetic prenatal diagnosis and genetic evaluation of stillbirths. The two large studies, published in the current edition of the New England Journal of Medicine, represent the largest head-to-head studies comparing CMA to traditional karyotyping. Both concluded that CMA identified additional, clinically significant genetic abnormalities compared to karyotyping in both the prenatal diagnostic setting as well as the evaluation of stillbirths.
Ronald Wapner, M.D., one of the nation's leading clinicians in the field of reproductive genetics and the lead author of the prenatal diagnosis study and a co-author on the stillbirth study, has called for CMA to replace karyotyping, which has been the traditional standard of care for these tests. Wapner is the Director of Reproductive Genetics at New York Presbyterian Hospital/Columbia University Medical Center, and the Vice Chairman of Research and Professor of Obstetrics and Gynecology at Columbia College of Physicians and Surgeons.
While Wapner noted that the transition to CMA from karyotyping in clinical practice will be gradual, as physicians and patients continue to be educated about its use, the two studies make the choice clear: "Why would anyone want to continue to use the standard method, which gives only part of the answer?" Dr. Wapner said in a statement published earlier this year by the New York Presbyterian and Columbia University Medical Center.
The larger of the two studies, entitled "Chromosomal Microarray Versus Karyotyping for Prenatal Diagnosis," enrolled 4,406 women. In 4,340 (98.8 percent) of the fetal samples, microarray analysis was successful. The second study, entitled "Karyotype Versus Microarray Testing for Genetic Abnormalities After Stillbirth," 532 stillbirths were analyzed. That study concluded that "microarray analysis is more likely than karyotype analysis to provide a genetic diagnosis, primarily because of its success with nonviable tissue, and is especially valuable in analyses of stillbirths with congenital anomalies…"
Both studies were funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development--part of the National Institutes of Health (NIH).
R. Judd Jessup, President and CEO of CombiMatrix, the only publicly-traded company that specializes in CMA, noted that the studies showed conclusively the value of microarray testing. "The CMA test could eventually give parents, physicians and educators better tools for anticipatory care by proactively addressing the impacts of many chromosomal disorders," Jessup said.
In the case of stillbirths or miscarriages, especially when it happens more than once, "CMA can be used to determine if there is a genetic reason for these occurrences, and can give parents valuable information about future pregnancies," says Jessup.
About CombiMatrix Corporation
CombiMatrix Corporation, through its wholly owned subsidiary, CombiMatrix Molecular Diagnostics, Inc. (CMDX), is a molecular diagnostics laboratory which offers DNA-based testing services to the prenatal, pediatric and oncology markets. The Company performs genetic testing utilizing Microarray, FISH, PCR and G-Band Chromosome Analysis. CMDX offers prenatal and pediatric testing services for the detection of abnormalities of genes at the DNA level beyond what can be identified through traditional technologies. CMDX was also the first commercial clinical laboratory in the United States to make comprehensive DNA-based genomic analysis of solid tumors, including breast, colon, lung, prostate and brain tumors, available to oncology patients and medical professionals. Additional information about CMDX is available at www.cmdiagnostics.com or by calling 1-800-710-0624.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations, speak only as of the date hereof and are subject to change. All statements, other than statements of historical fact included in this press release, are forward-looking statements. Forward-looking statements can often be identified by words such as "anticipates," "expects," "intends," "plans," "goal," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "could," "potential," "continue," "ongoing," "objective," similar expressions, and variations or negatives of these words and include, but are not limited to, statements regarding the advantages and efficacy of CMA over standard karyotyping. These forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause our actual results to differ materially and adversely from those expressed in any forward-looking statement. The risks and uncertainties referred to above include, but are not limited to: market acceptance of CMA as a preferred method over karyotyping; the rate of transition to CMA from karyotyping; our ability to successfully expand the base of our customers and strategic partners, add to the menu of our diagnostic tests in both of our primary markets, develop and introduce new tests and related reports, optimize the reimbursements received for our testing services, and increase operating margins by improving overall productivity and expanding sales volumes; our ability to successfully accelerate sales, allow access to samples earlier in the testing continuum, steadily increase the size of our customer rosters in both developmental medicine and oncology; our ability to attract and retain a qualified sales force; rapid technological change in our markets; changes in demand for our future products; legislative, regulatory and competitive developments; general economic conditions; and various other factors. Further information on potential factors that could affect our financial results is included in our Annual Report on Form 10-K, Quarterly Reports of Form 10-Q, and in other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.
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SOURCE: CombiMatrix Corporation
CONTACT: Company Contact: R. Judd Jessup President & CEO, CombiMatrix Corporation Tel (949) 753-0624 Investor Relations Contact: John Baldissera BPC Financial Marketing Tel (800) 368-1217 Media Contact: Len Hall VP, Media Relations Allen & Caron Tel (949) 474-4300 len@allencaron.com
