CombiMatrix Launches Preimplantation Genetic Diagnostic Testing for Single Gene Disorders and Chromosomal Translocations

IRVINE, Calif., April 05, 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 the launch of CombiPGD™ - Preimplantation Genetic Diagnosis (PGD) for single gene disorders and chromosomal translocations.  CombiPGD is a test performed prior to embryo implantation to help identify genetic defects created through in vitro fertilization to prevent certain diseases or disorders from being passed on to the child.

Assisted reproductive technology is typically associated with infertility. However, some fertile couples whose children are at risk for a specific genetic disease or hereditary chromosomal abnormality choose to undergo in vitro fertilization in order to perform PGD. CombiMatrix already offers CombiPGS™, which is a test that may help decrease the rate of implantation failure and miscarriage by allowing physicians to identify and transfer chromosomally normal embryos.

“We are pleased to launch another incremental revenue-producing test in the IVF market that meets a critical clinical need. The CombiPGD test rounds out our IVF test offering, where we also offer PGS testing, parental karyotyping and miscarriage analysis testing,” said Mark McDonough, President and Chief Executive Officer of CombiMatrix. “CombiPGD allows couples who are at significant risk of having a child with a serious disorder the opportunity to gain important information about their embryos before implantation with the goal of implanting only those embryos without the disease of concern.”

A number of different technologies are currently being used for both PGD and PGS. In contrast to some of the older approaches to PGD testing, the two major benefits of the CombiPGD approach are its broad applicability and streamlined implementation. Unlike the laborious processes of developing and validating PCR probes for each individual disease gene, CombiMatrix utilizes a genome-wide set of single nucleotide polymorphisms as markers to “track” a gene with the mutation from parent to child. This enables the test to be used for virtually any single gene disorder and to replace the typical eight to 12 week waiting period for test development to under three weeks.

“Most patients pursuing this technology in our practice have been referred to us because they already have an affected child, or they have recently discovered that they are carriers of a genetic disease that they are at risk of transmitting to their future children,” explained Matthew C. Goering, PhD, Director of Clinical Embryology at the Center for Advanced Reproductive Medicine at the University of Kansas and Assistant Professor at the University of Kansas Department of Obstetrics and Gynecology Division of Reproductive Endocrinology and Infertility.

“In the last few years we have witnessed an exponential rise in the use of carrier screening for inherited genetic diseases among patients of reproductive age,” added Dr. Goering. “This growth in procreative genetic screening, along with improvements in the technology and success rates associated with IVF and embryo biopsy, have led to a significant increase in the demand for preimplantation genetic testing in our IVF practice. Genetic testing of this type is inherently challenging due to the astonishingly small size of the samples – typically just a few cells from each embryo.  Thus, as the demand for this new technology has risen, so has the need for high-quality, experienced, genetic diagnostic laboratories that offer the service.”  Dr. Goering is a member of CombiMatrix’ Scientific Advisory Board.

In 2015, CombiMatrix entered the infertility market with a disruptive, patient-centered approach to test pricing, including both a multi-cycle and per-embryo price structure for PGS. Based on the success of this model and customer adoption over the past year, CombiMatrix is now offering their PGD testing with the same flexible options.

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.

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 and include, but are not limited to, statements regarding projected results of operations and management's future business, operational and strategic plans, recruiting efforts and test menu expansion. 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 CombiPGD test; 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; 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.