IRVINE, Calif., June 18, 2013 (GLOBE NEWSWIRE) -- CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics company performing DNA-based testing services for developmental disorders and cancer diagnostics, today announced that its volumes of prenatal testing have shown a significant uptick since data from two National Institutes of Health (NIH) studies showed the value of chromosomal microarray analysis (CMA).
The larger study (published in conjunction with the National Institute of Child Health and Human Development [NICHD]), which had over 4,400 patients enrolled, was published in the New England Journal of Medicine (NEMJ) in December 2012 and presented at the annual meeting of the Society for Maternal-Fetal Medicine in February, concluded that CMA identified additional clinically significant genetic abnormalities compared to traditional karyotyping when testing prenatal samples. CombiMatrix is the only publicly-traded company that specializes in CMA.
"The NICHD study clearly demonstrated the superiority of microarrays over traditional karyotyping," said Jim Goldberg, MD of San Francisco Perinatal Associates. "Due to the strength of the data in that study, we now counsel patients on the availability of microarray testing and offer this option to them as a first tier test." Dr. Goldberg reiterated, "The clinical utility of microarrays are their ability to detect chromosomal copy number abnormalities that are missed by traditional karyotyping. The accuracy of microarray, coupled with the test's fast turn-around-time, helps reduce patients' anxiety by providing comprehensive results as we move toward this new standard of care."
Some clinicians have been slow to adopt microarray testing because of concerns about variants of uncertain significance (VOUS). Dr. Goldberg emphasizes, "These types of findings are a routine part of prenatal diagnosis as a whole. Microarray testing identifies clinically significant chromosomal abnormalities that have gone undetected by karyotyping. As we learn more about these undetected chromosomal copy number changes, clinicians will become more comfortable explaining their significance to patients."
At CombiMatrix, volumes of testing for both miscarriage management and prenatal genetic testing have grown rapidly, as previously reported in the Company's first quarter 2013 earnings release.
"We believe that the very clear data published in the NEJM on both stillbirths and on invasive procedures highlight the value of CMA and is driving the uptick in our prenatal testing volumes," CombiMatrix President and CEO Mark McDonough said. "The data has generated momentum that tells us, first, we made the correct decision when we decided to make a strategic shift to focus on the developmental markets where CMA is becoming the standard of care. But second, it also shows that we continue to take market share from our competitors. We are excited and well positioned to help drive the conversion from karyotyping to microarrays over the next several quarters."
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.
CONTACT: Company Contact: Mark McDonough President & CEO, CombiMatrix Corporation Tel (949) 753-0624 Media Contact: Len Hall VP, Media Relations Allen & Caron Tel (949) 474-4300 firstname.lastname@example.org Investor Relations Contact: John Baldissera BPC Financial Marketing Tel (800) 368-1217