IRVINE, Calif., Aug. 18, 2015 (GLOBE NEWSWIRE) -- CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics company specializing in DNA-based testing services for prenatal and postnatal developmental disorders and pre-implantation genetic screening services, today announced its SNP-based chromosomal microarray analysis (CMA) test for prenatal diagnosis, the CombiSNP™ Array for Prenatal Diagnosis, has received approval from the New York Department of Health (NYDOH) thus allowing the company to market the test in New York State.
CMA uses chorionic villus sampling (CVS) and amniocentesis samples to detect chromosomal imbalances that are not detected by karyotyping. Studies have shown that approximately one in 17 women who have a pregnancy with fetal ultrasound abnormalities and a normal fetal karyotype will have a clinically significant chromosomal abnormality detected by CMA. The American College of Obstetrics and Gynecology (ACOG) recommends prenatal microarray analysis when major structural fetal abnormalities are identified by ultrasound. In addition, CMA is recommended for confirmation of positive non-invasive prenatal testing (NIPT) results in order to preclude false positive results that can accompany the NIPT.
"With this approval, we now offer a more complete portfolio of prenatal testing services to physicians in the New York market," said Mark McDonough, President and Chief Executive Officer of CombiMatrix. "The prenatal diagnostic test we offer is important both as a first-tier test and as a tool physicians utilize to confirm the increasing number of positive non-invasive prenatal screening results. We are excited about the opportunity to provide our high-quality testing services to our maternal-fetal medicine and OB/GYN customers in the third most populated state in the country.
"We see very significant growth opportunities for our prenatal diagnostics testing in the New York market," he added. "Over the past two years, we have been successful at driving the adoption in this market for recurrent pregnancy loss with our CMA test on products of conception despite not having any locally based New York sales representation. Our entry into the New York market with our prenatal diagnostic testing will allow us to optimize our current sales force and we recently hired two additional sales representatives to capitalize on this opportunity. We also plan to leverage the New York-based representatives of our partner, Sequenom, for prenatal diagnostic services."
About CombiMatrix Corporation
CombiMatrix Corporation provides valuable molecular diagnostic solutions and comprehensive clinical support to foster the highest quality in patient care. CombiMatrix specializes in prenatal diagnostics, miscarriage analysis for recurrent pregnancy loss, pediatric genetics and pre-implantation genetic screening, offering DNA-based testing for the detection of genetic abnormalities beyond what can be identified through traditional methodologies. CombiMatrix performs genetic testing utilizing a variety of advanced cytogenomic techniques, including chromosomal microarray, standardized and customized fluorescence in situ hybridization (FISH) and high-resolution karyotyping. CombiMatrix is dedicated to providing high-level clinical support for healthcare professionals in order to help them incorporate the results of complex genetic testing into patient-centered medical decision making. Additional information about CombiMatrix is available at www.combimatrix.com or by calling (800) 710-0624.
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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," similar expressions, and variations or negatives of these words and include, but are not limited to, statements regarding projected results of operations and management's future business, operational and strategic plans, recruiting efforts and test menu expansion. 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: our ability to successfully expand the base of our customers and strategic partners, add to the menu of our diagnostic tests, develop and introduce new tests and related reports, expand and improve our current suite of services, optimize the reimbursements received for our microarray testing services, and increase operating margins by improving overall productivity and expanding sales volumes; our ability to successfully accelerate sales, steadily increase the size of our customer rosters in both prenatal and developmental genetic testing markets; our ability to attract and retain a qualified sales force in wider geographies; our ability to ramp production from our sales force and our strategic partners; rapid technological change in our markets; changes in demand for our future services; legislative, regulatory and competitive developments; the outcome of pending litigation; 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.