IRVINE, Calif., March 23, 2016 (GLOBE NEWSWIRE) — CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics company specializing in DNA-based testing services for prenatal and postnatal developmental disorders and pre-implantation genetic screening services, announces that the American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recently updated their practice bulletins recommending that all pregnant women regardless of age or other risk factors be offered prenatal assessment for aneuploidy and other genetic disorders. The updated information for prenatal testing was issued in Practice Bulletins “Prenatal Diagnostic Testing for Genetic Disorders” (Number 162, May 2016) and “Screening or Fetal Aneuploidy (Number 163, May 2016).
Among the updates, ACOG and SMFM significantly lowered the procedure-related risk of pregnancy loss for chorionic villous sampling (CVS) to 1 in 455 and for amniocentesis to 1 in 900, based on recent meta-analysis of available data. These revised risk assessments are expected to substantially diminish patient concerns and increased acceptance of prenatal invasive testing for any risk or age category. The new guidelines also recommend that chromosomal microarray analysis should be the primary test for invasive prenatal assessment, as well as for fetal death and stillbirth analysis, due its ability to detect abnormalities that may be missed by other diagnostic methods.
Additional key points in the practice bulletin guidelines include the value of providing pregnant women with pre-test education and post-test counseling, as well as the necessity to conduct confirmatory testing following positive screening for genetic abnormalities, and a recommendation against the use of prenatal screening in detecting microdeletions due to the limited validation data. The bulletins also reinforce ACOG and SMFM’s prior position that due to the potential for false-positive results, screening tests for aneuploidies such as Down syndrome are not a substitute for diagnostic testing.
“ACOG and SMFM are taking important steps with these updated practice bulletins to provide a path by which physicians and their patients can make better informed decisions about pregnancies,” said CombiMatrix President and Chief Executive Officer, Mark McDonough. “The new analysis indicates that CVS and amniocentesis are far less risky to pregnancy loss than previously believed by these associations as well as within the diagnostic industry. Importantly, the bulletins reemphasize the necessity for confirmatory diagnostic testing as a reflex when screening tests indicate positive results for fetal genetic abnormalities and further points to chromosomal microarray analysis, which is offered by CombiMatrix, as the recommended test. We feel the recent changes to the ACOG Bulletin will help patients and physicians to be better educated on the reduced risk of miscarriage from invasive procedures, thus potentially leading to increased ordering of more comprehensive diagnostic testing.
“We commend ACOG and SMFM for recognizing the value of providing prenatal genetic counseling to physicians and their patients,” McDonough added. “I’m very proud of our high-touch focus at CombiMatrix and in the quality of our tests, our technological capabilities and our genetic counselors that enable us to provide vital information in a compassionate way to the physicians and patients we service.”
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 prenatal diagnostics, miscarriage analysis for recurrent pregnancy loss, pediatric genetics and pre-implantation genetic screening, 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.
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,” 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: whether revised ACOG and SMFM guidelines will lead to a greater number of invasive diagnostic tests ordered; our ability to successfully expand the base of our customers and strategic partners, 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; 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: | Investor Relations Contact: |
| Mark McDonough | LHA |
| President & CEO, CombiMatrix Corporation | Jody Cain |
| (949) 753-0624 | (310) 691-7100 |
| jcain@lhai.com |
