- Published: 16 October 2014
- Written by Editor
Data to be Presented at ASHG 2014 Show That Miscarriage Analysis by Chromosomal Microarray Yields a Successful Result in More Than 85% of Cases
Results Will Be Presented by Trilochan Sahoo, M.D., Director of Cytogenetics at CombiMatrix
IRVINE, Calif., Oct. 14, 2014 -- CombiMatrix Corporation (CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre- and postnatal developmental disorders, today announced data from a comprehensive, multi-year analysis of products of conception (POC) testing by chromosomal microarray analysis (CMA) showing that CMA yields a successful result in more than 85% of cases. Trilochan Sahoo, M.D., Director of cytogenetics at CombiMatrix, will present results at the American Society of Human Genetics (ASHG)'s 64th Annual Meeting on Monday, October 20, 2014 in San Diego, California.
CombiMatrix analyzed 3,408 consecutive specimens that included both fresh POC tissue and archived formalin-fixed, paraffin-embedded (FFPE) samples. Results showed that 2,345 out of 2,712 (86.5%) fresh POC samples and 492 out of 564 (87.2%) FFPE samples provided a successful result, with common reasons for test failure including insufficient sample size and poor DNA quality.
"Chromosomal abnormalities account for more than half of all first trimester pregnancy losses, and determining the cause of pregnancy loss can assist in providing appropriate medical management and recurrence risk counseling to patients," said Dr. Sahoo. "Classical cytogenetic analysis of POC using karyotyping requires the successful culture of a fresh POC specimen and yields a successful result 60% of the time, on average, depending upon sample type. In contrast, CMA enables the direct analysis of both fresh and archived POC tissue, requiring only genomic DNA, and yields a successful result more often, thus offering meaningful advantages over the traditional methodology."
For the study, CombiMatrix used three CMA platforms -- BAC-aCGH, oligo-aCGH and single nucleotide polymorphism (SNP) array. Of the three platforms, the SNP array had the highest abnormality detection rate (53.8%) and, in addition to chromosomal imbalances, also identified cases with whole genome or multiple regions of allelic homozygosity.
"At CombiMatrix, we are committed to making technological and scientific advancements while concurrently growing commercially," said Mark McDonough, President and Chief Executive Officer of CombiMatrix. "Our laboratory and scientific team are experts at handling and testing FFPE tissue, and this capability differentiates CombiMatrix and our CMA offering from other cytogenetics labs. The results of this analysis that we will present at ASHG validate the added benefits of the high-resolution, genome-wide SNP array, which is the platform that underlies our current test offerings."
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: 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 (949) 753-0624 Investor Contact: Robert Flamm, Ph.D. Russo Partners, LLC (212) 845-4226 This email address is being protected from spambots. You need JavaScript enabled to view it. Media Contacts: David Schull or Lena Evans Russo Partners LLC (212) 845-4271 (212) 845-4262 This email address is being protected from spambots. You need JavaScript enabled to view it. This email address is being protected from spambots. You need JavaScript enabled to view it.
