IRVINE, Calif., April 10, 2015 (GLOBE NEWSWIRE) -- CombiMatrix Corporation (Nasdaq: CBMX ), a molecular diagnostics company specializing in DNA-based diagnostic services for prenatal, postnatal, and pre-implantation genetic testing today announced that an article and a letter to the editor published online on April 1, 2015 in the New England Journal of Medicine support the need for follow-up confirmatory diagnostic testing following a positive noninvasive prenatal screening test (NIPT) result.
In a prospective, multicenter study of 15,841 women, Norton et al., (April 1, 2015 DOI: doi/pdf/10.1056/NEJMoa1407349) found that despite NIPT's high sensitivity and specificity compared to standard screening, the positive predictive value (i.e. the chance that a positive result accurately identifies an affected pregnancy) of NIPT is limited, making it essential to follow up a positive NIPT result with confirmatory prenatal diagnostic testing. In a letter to the editor in the same issue, Cheung, Patel, and Leung (April 1, 2015DOI: 10.1056/NEJMc1412222) discussed some of the biological causes of the inherent limitations of NIPT and recommend that such assays be referred to only as "DNA-based noninvasive prenatal screening" to emphasize the screening nature of the testing.
"Noninvasive prenatal testing is an excellent tool to screen for chromosomal abnormalities in a developing fetus," said Mark McDonough, President and Chief Executive Officer of CombiMatrix. "That said, these tests are screening tests and it is very important that positive results be confirmed by invasive prenatal diagnostic testing so that the most informed clinical decision can be made by the patient and her physician. In our own experience as a provider of prenatal diagnostic testing services, we have witnessed many cases in which our diagnostic tests do not confirm the abnormality suspected by NIPT, thereby circumventing decisions that may have been made based on a screening test alone. We believe this is why, after evaluating numerous studies, the American College of Obstetricians and Gynecologists (ACOG) has issued a Committee Opinion advising that invasive prenatal diagnostic testing be performed to confirm any positive NIPT results."
About CombiMatrix Corporation
CombiMatrix Corporation provides valuable molecular diagnostic solutions and comprehensive clinical support for the highest quality of care – specializing in pre-implantation genetic screening, 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 our mircroarray diagnostic tests to confirm positive NIPT results; 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, steadily increase the size of our customer rosters; our ability to attract and retain a qualified sales force; rapid technological change in our markets; changes in demand for our future services; 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 Media Contact: David Schull or Lena Evans Russo Partners LLC (212) 845-4271
