- Published: 25 June 2013
- Written by Editor
CombiMatrix Granted Conditional Approval From New York State Department of Health to Market Prenatal Miscarriage Analysis Test
Opens Large New Market for Leading Growth Product
CombiMatrix Corporation (CBMX), a molecular diagnostics company performing DNA-based testing services for developmental disorders and cancer diagnostics, today announced that its chromosomal microarray analysis (CMA) test for miscarriage analysis has received conditional approval from the New York State's Department of Health for testing on patient samples from the state. With nearly 20 million people, New York is the third most populated state in the nation, behind only California and Texas.
The Company's CMA test for miscarriage analysis, also called a Product of Conception (POC) test, is currently CombiMatrix's fastest growing test in terms of volumes. CombiMatrix previously announced on June 18th that volumes from both of its prenatal CMA tests have increased significantly in the past six months following the publication of data from two National Institutes of Health (NIH) studies showing the superiority of CMA over traditional karyotyping for identifying clinically significant genetic abnormalities.
"Gaining the conditional license and ultimately the final approval to market and sell our POC test throughout New York is an important milestone for us that will allow us to broaden the market for our number one growth product," said CEO Mark McDonough. "As approved under the conditional license, we will now begin to sell directly to customers and to seek distribution partnerships to leverage our internal sales force. This could be a tremendous opportunity for us and, we believe, for the physicians and patients in New York."
About CombiMatrix Corporation
CombiMatrix Corporation provides valuable molecular diagnostic solutions and comprehensive clinical support for the highest quality of care -- specializing in miscarriage analysis, prenatal and pediatric healthcare. CombiMatrix offers comprehensive testing services for the detection of abnormalities of genes at the DNA level beyond what can be identified through traditional technologies. The Company performs genetic testing utilizing microarray, FISH, PCR and G-Band chromosome analyses. Additional information about CombiMatrix is available at www.combimatrix.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.
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 This email address is being protected from spambots. You need JavaScript enabled to view it. Investor Relations Contact: John Baldissera BPC Financial Marketing Tel (800) 368-1217
