IRVINE, Calif., Jan. 7, 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 it expects to report record volumes of prenatal testing in the fourth quarter and year ended December 31, 2012. Preliminary annual growth rates of 172 percent and 171 percent were achieved for billable prenatal tests in the quarter and full year, respectively. The rapid growth rate in prenatal testing, which includes both prenatal and miscarriage testing, is the result of the Company's strategic shift to focus on its prenatal molecular diagnostics testing markets, where the Company believes that chromosomal microarray analysis (CMA) is becoming the standard of care. CombiMatrix is the only publicly-traded company that specializes in CMA.
R. Judd Jessup, President and CEO of CombiMatrix said, "Our refocused commercial strategy began to kick in during the latter half of 2012 and especially in the fourth quarter. We believe our focus on CMA in the prenatal and pediatric segments is allowing us to gain traction and marketshare as the technology landscape and standard of care changes. In addition, recent key clinical publications bolstering that paradigm shift should continue to add momentum in those markets as 2013 progresses."
Late in 2012, a pair of studies published in the New England Journal of Medicine, favored CMA over traditional karyotyping for genetic prenatal diagnosis and genetic evaluation of stillbirths. The two large studies, published in the December edition of the Journal, represented 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.
Jessup continued, "CMA gives parents, physicians and educators better tools for anticipatory care by proactively addressing the impacts of many chromosomal disorders. In the case of stillbirths or miscarriages, CMA can be used to determine if there is a genetic reason for these occurrences, especially when it happens more than once, and can give parents valuable information about future pregnancies."
Overall billable testing volumes at the Company, including its de-emphasized oncology segment, was also up strongly in the period, growing 21 percent and 25 percent in the quarter and full year, respectively, over 2011. CombiMatrix expects to report its operating results in late February, 2013 and file its annual report for 2012 on Form 10-K in mid-March, 2013. The Company will issue a press release and hold an investor conference call to discuss results.
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, the market momentum for CMA, the impact of our CMA focus on market share, and our preliminary report of prenatal testing volumes. 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: the risk that our final reported prenatal testing volumes are different from this preliminary report; 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.