New Data From Multi-Year Study of Pregnancy Loss Support Efficacy and Diagnostic Power of CombiMatrix's Chromosomal Microarray Analysis
Data on Genetic Analysis of Pregnancy Loss to be Presented at the World Congress on Recurrent Pregnancy Loss
IRVINE, Calif., Jan. 06, 2016 (GLOBE NEWSWIRE) -- CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics company specializing in DNA-based testing services for prenatal, miscarriage analysis and postnatal developmental disorders and pre-implantation genetic screening (PGS) services, announces that new data from a multi-year study support the efficacy of SNP-based chromosomal microarray analysis (CMA) in detecting chromosomal imbalances. Data from the study conducted by CombiMatrix will be presented by Trilochan Sahoo, M.D., FACMG, the company’s Vice President of Clinical Affairs and Director of Cytogenetics, at the World Congress on Recurrent Pregnancy Loss in Cannes, France on January 16, 2016.
“With successful analysis and results from more than 90% of products of conception samples, our findings show that CMA is the most effective diagnostic test for identifying chromosomal abnormalities in these samples,” said Dr. Sahoo. “CMA testing improves diagnostic sensitivity in both fresh and formalin-fixed, paraffin-embedded (FFPE) samples compared with analysis by karyotyping, which may fail to produce results in 20% to 40% of cases.”
The study was conducted over a 44-month period reviewing data from more than 8,000 products of conception samples comprised of both fresh (76.4%) and FFPE (22.4%) samples. The majority of samples (83%) were ascertained for recurrent pregnancy loss and/or spontaneous abortion. Additionally, 81.6% of samples were evaluated using a whole genome SNP-based CMA array and the remainder by array-CGH (comparative genomic hybridization). Highlights of the study include:
- Successful analysis of 91.1% of samples (92.4% of fresh and 86.4% of FFPE)
- Clinically significant abnormalities detected in 53.7% of successfully analyzed samples, of which 95% were causative
“These impressive, large-scale study results support our SNP-based CMA as a powerful platform to identify aneuploidy, polyploidy, segmental genomic imbalances and maternal cell contamination, and build on our expertise as a world leader in miscarriage analysis,” said Mark McDonough, President and Chief Executive Officer of CombiMatrix. “This is a rapidly growing market opportunity for CombiMatrix with over one million women suffering miscarriages in the United States annually. With increased diagnostic sensitivity, CMA reduces the occurrence of false negative results. Importantly, an enhanced understanding from using CMA of the cause and recurrence risks of fetal loss helps patients make better informed family planning decisions.”
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 pre-implantation genetic screening, miscarriage analysis, prenatal and pediatric diagnostics, 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. 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 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.
Company Contact: Mark McDonough President & CEO, CombiMatrix Corporation (949) 753-0624 Investor Relations Contact: LHA Jody Cain (310) 691-7100 firstname.lastname@example.org