NIH Studies in New England Journal of Medicine Favor Chromosomal Microarray Analysis Over Standard Karyotyping for Genetic Analysis Largest Head-to-Head Studies Comparing the Two Diagnostic Tools; CombiMatrix: Only Publicly-Traded Diagnostic Laboratory Specializing in Microarray Analysis
IRVINE, Calif., Dec. 7, 2012 (GLOBE NEWSWIRE) -- CombiMatrix Corporation ( 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. |
