CombiMatrix's Array for Pre-Implantation Genetic Screening Granted Conditional Approval From New York State Department of Health
With This Conditional Approval, CombiMatrix Now Markets All of Its Diagnostic Tests in New York State
IRVINE, Calif., Dec. 10, 2015 (GLOBE NEWSWIRE) -- CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics company specializing in DNA-based testing services for prenatal, miscarriage analysis and postnatal developmental disorders and pre-implantation genetic screening (PGS) services, today announced that its CombiPGS™ test for women undergoing in vitro fertilization (IVF) has received conditional approval from the New York State Department of Health. CombiPGS allows couples to screen embryo biopsy cells for chromosomal abnormalities prior to implantation of the embryo in order to maximize the chance of successful implantation and pregnancy progression and to decrease the likelihood of a miscarriage.
"The demand for our CombiPGS test across the country has been strong since our launch in early 2015. We are very excited to now offer this service in New York State, which ranks second only to California in the total number of IVF cycles performed nationally each year," said Mark McDonough, President and Chief Executive Officer of CombiMatrix. "California has been our top producing state for the adoption of CombiPGS and we are optimistic that we can replicate that success in New York. It is worth noting that CombiMatrix is the first national commercial diagnostic laboratory to offer PGS testing with per-embryo pricing, allowing patients to only pay for those embryos being tested.
"With CombiPGS, we are applying our industry-leading experience with microarray technology and our high-touch clinical support to what we believe is a lucrative cash-pay market that is estimated to be $75 million annually and growing," added McDonough. "As we have highlighted before, the reproductive endocrinologist/IVF physician is an important call point for us. We now offer our fastest growing product, the CombiSNP™ Array for Pregnancy Loss, CombiPGS, and our Parental Karyotyping tests to these clinics and are leveraging our established commercial infrastructure and expertise to grow these three product lines nationally.
"We believe our comprehensive portfolio of prenatal testing services available to physicians in the New York market enables us to maximize the efficiency of our sales force in this significant market. This past summer, we invested in two sales representatives in New York to capitalize on this opportunity. Over the past two years, we have been successful driving our test adoption in the New York market for miscarriage analysis, and we see a high potential for growth with CombiPGS," concluded McDonough.
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," "optimistic," "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: our ability to successfully market our CombiPGS and other diagnostic test offerings in the State of New York, to obtain final approval from the State of New York for our CombiPGS, 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.
CONTACT: Company Contact: Mark McDonough President & CEO, CombiMatrix Corporation (949) 753-0624 Investor Relations Contact: LHA Jody Cain (310) 691-7100 firstname.lastname@example.org