CombiMatrix Launches Next Generation Sequencing for Pre-Implementation Genetic Screening

High sensitivity and specificity PGS testing by Next Generation Sequencing supports healthy pregnancies and builds on prenatal diagnostics portfolio

 

IRVINE, Calif., June 01, 2016 -- CombiMatrix Corporation (CBMX), a molecular diagnostics company specializing in DNA-based testing services for pre-implantation genetic diagnostics and screening, miscarriage analysis, prenatal and pediatric diagnostics, announces that it will begin accepting samples for pre-implantation genetic screening (PGS) by next generation sequencing (NGS) in mid-June. 

 

PGS is a test performed on embryos of couples undergoing an in vitro fertilization (IVF) procedure and is designed to examine embryos for chromosomal abnormalities prior to implantation. This procedure reduces the risk for miscarriage and abnormal pregnancies and increases the success rate of the implantation and of a normal pregnancy. 

The NGS technology now being adopted by CombiMatrix and made available for all PGS testing provides unparalleled accuracy and sensitivity in the detection of both whole chromosome and segmental aneuploidies. Comprehensive coverage of the entire genome achieves increased clarity and higher resolution of both chromosomal and sub-chromosomal alterations. The highly streamlined workflow also reduces turnaround time for reported test results.

 

“PGS testing provides valuable information for family planning decision making and supports healthy pregnancies," said Mark McDonough, President and Chief Executive Officer of CombiMatrix. “PGS testing by NGS adds another accretive assay to our IVF offering and complements our current reproductive health diagnostics portfolio. This will allow us to build on momentum in our miscarriage analysis and prenatal diagnostics testing businesses with our established customers. As with all of CombiMatrix’s tests, we will provide our signature high-touch service model for this test that includes the genetic counseling support that is critical for complicated cases.

 

“We estimate the U.S. market for PGS at approximately $75 million annually and growing as more physicians and families recognize the benefits of this information,” he added. “This new offering is expected to drive our PGS testing volume through new customer adoption and improve gross margins as procedure volumes increase. As the vast majority of PGS testing is self-paid, this testing will also support our high cash reimbursement rate, which is an important aspect of our business model. We look forward to leveraging our NGS capabilities to bring other value-added tests to market in the coming months and years.”

 

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 atwww.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: adoption and market acceptance of our next generation sequencing test offering, 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.

 

 

Company Contact:	Investor Relations Contact:
Mark McDonough	LHA
President & CEO, CombiMatrix Corporation	Jody Cain
(949) 753-0624	(310) 691-7100
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