CombiMatrix's SNP-Based Miscarriage Analysis Test Granted Conditional Approval From New York State Department Of Health
Irvine, CA (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 SNP-based chromosomal microarray analysis (CMA) test for miscarriage analysis, the CombiSNP™ Array for Pregnancy Loss, or products of conception, has received conditional approval from the New York Department of Health (NYDOH). This approval is for testing on fresh and formalin fixed paraffin embedded (FFPE) patient samples. Last year, the Company's CMA miscarriage analysis test for fresh tissue was conditionally-approved by NYDOH.
Over one-half of all first trimester pregnancy losses are due to chromosomal abnormalities. Older technologies, such as Karyotyping, are subject to frequent cell culture failure, but microarray testing is DNA-based, and does not require cell culturing. Unlike older microarray methodologies, the CombiSNP™ array can identify triploidy and molar pregnancies as well. In addition, the CombiSNP™ Array for Pregnancy Loss can use FFPE samples so the analysis can be performed if no fresh tissue is available.
"The availability of this SNP-based CMA test provides New York physicians the flexibility to either use fresh tissue or stored FFPE tissue when fresh tissue is not available," said Mark McDonough, chief executive officer of CombiMatrix. "In addition, this conditional license is the second this month, following conditional approval to market our CombiSNP™ CMA test for pediatric analysis, and the third since last year that we have received from the New York Department of Health. This approval enables CombiMatrix to market both of our CMA miscarriage analysis tests in New York state. We view these conditional approvals as validation of our regulatory and clinical capabilities to bring new test solutions to our customers."
Under conditional approval, CombiMatrix will be able to market the test in New York while the test is under Clinical Laboratory Reference System review. Upon completion of the review, either the test will receive full marketing approval or additional information will be required in order to achieve final approval.
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. 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: obtaining full approval from the NYDOH to sell SNP-based miscarriage analysis tests in New York State; 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.
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SOURCE: CombiMatrix Corporation