CombiMatrix Study Published in Genetics in Medicine Establishes the Superior Diagnostic Value of Microarray Analysis over Karyotyping for Recurrent Pregnancy Loss Testing

IRVINE, Calif., June 24, 2016 (GLOBE NEWSWIRE) -- CombiMatrix Corporation CBMX, a molecular diagnostics company specializing in DNA-based reproductive health and pediatric testing services, announces the publication of data from a large retrospective study demonstrating a high success rate and superior diagnostic power of chromosomal microarray analysis for recurrent pregnancy loss testing.  The study was conducted by CombiMatrix, a leading provider of microarray testing for miscarriage analysis. 

In the largest study of its kind involving pregnancy loss, more than 8,000 consecutive products of conception (POC) samples received by CombiMatrix over a 44-month period were analyzed and results were successfully obtained for more than 90% of the cases. This compares with reported success rates of between 60-80% for samples evaluated using the traditional testing method of karyotyping. Importantly, clinically significant abnormalities were identified in 53.7% of samples, 95% of which were considered causative of the pregnancy loss.  Results of the study are featured in "Comprehensive genetic analysis of pregnancy loss by chromosomal microarrays, outcome, benefits, and challenges," (T. Sahoo, et al) in the advanced online publication of peer-reviewed Genetics in Medicine (2016) doi:10.1038/gim.2016.69.

"The market for miscarriage analysis has increased dramatically over the past few years and we expect that these outstanding clinical results will further drive demand and payer reimbursement for the use of microarray analysis for this testing," said Mark McDonough, President and Chief Executive Officer of CombiMatrix.  "We are proud of our position as a commercial and scientific leader in the estimated $300 million annual U.S. market for miscarriage analysis testing.  This is the fastest growing segment of our business and is an important contributor to our revenue growth and path to profitability."

"Karyotyping has been the standard practice in recurrent pregnancy loss testing, but has major drawbacks in terms of high failure rates (20-40% cases), long turnaround times and a high risk of maternal cell contamination during culture that can significantly confound accurate results," said study author Trilochan Sahoo, M.D., FACMG, CombiMatrix's Vice President of Clinical Affairs and Director of Cytogenetics. "Our high success rate with evaluating challenging POC samples includes both fresh and formalin-fixed, paraffin-embedded (FFPE) samples, thus providing significant advantages and options to clinicians and providers.  Further, the ability of single nucleotide polymorphism (SNP)-based microarray analysis to identify aneuploidy, polyploidy, whole-genome homozygosity, segmental genomic imbalances and maternal cell contamination maximizes sensitivity and decreases the number of false-negative results."

"The information provided by microarray analysis performed by CombiMatrix has far surpassed our hospital's expectations and has allowed our clinicians to provide the answers their patients seek," said Mandolin Ziadie, MD, Pathologist at Memorial Regional Hospital and CombiMatrix Scientific Advisor.  "Use of the test has resulted in improved patient care, pregnancy planning and counseling.  Most importantly, the data makes a notable contribution to our current understanding of the frequency and nature of both common and unusual genetic abnormalities that lead to or contribute to pregnancy loss. I can foresee this information as being an important guide for clinicians and their patients, and as an important source of data for research aimed at improving fertility and better understanding the causes of recurrent pregnancy loss."

"Recurrent pregnancy loss is an emotionally charged problem and is incredibly painful for the victims who suffer these losses," added McDonough. "It is also a significant medical dilemma, as an estimated 15-20% of all clinically recognized pregnancies end in miscarriage. Providing accurate and timely diagnoses could have positive impact on patient counseling and management. We intend to continue driving scientific advancement to help better refine our understanding of the factors behind recurrent pregnancy loss.  It is our passion and objective to provide valuable information to families that will support their planning.

"We believe the results of this study will further educate the MFM/OB/RE physician community on the clinical importance of miscarriage analysis testing. We are pleased to report that the mounting data supporting use of microarray analysis as the preferred technology for testing is being increasingly recognized by health providers. So far in 2016, 15 insurance providers, including Cigna Health Services and multiple plans in the Blue Cross Blue Shield network, have revised their medical policies to include microarray testing as medically necessary for the evaluation of recurrent pregnancy loss." 

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 diagnostics and 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 next generation sequencing, 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 adoption and market acceptance of our microarray test offerings for miscarriage analysis will increase or whether third-party payors will expand coverage for this test based on published studies or clinical data, 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 and NGS 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.