CombiMatrix Announces Commercial Launch of Microarray Testing for Stillbirth Analysis
Expands Into Underserved $40 Million Domestic Market With ACOG-Recommended Microarray Genetic Diagnostic Testing
IRVINE, Calif., Jan. 28, 2016 (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, announces the commercial launch of its SNP microarray genetic diagnostic testing for intrauterine fetal demise (IUFD), commonly known as stillbirth genetic testing.
"Our expansion into the underserved IUFD market is a logical extension of our current microarray genetic testing for miscarriage analysis," said Mark McDonough, President and Chief Executive Officer of CombiMatrix. "We estimate the annual U.S. market for IUFD is $40 million and growing as more women choose to have children later in life. Our consistent volume and revenue growth in our miscarriage product line since its introduction in the first quarter of 2013 gives us confidence in our commercial team's ability to capitalize on this expanded market opportunity. We will continue to leverage our established relationships with hospital systems, OB/GYNs, maternal fetal medicine specialists and pathology laboratories to support this market expansion. We also have the benefit of marketing tailwinds that include a
growing portfolio of payer contracts and attractive reimbursement rates as well as the American College of Obstetrician and Gynecologists' (ACOG) recommendation that microarray testing be used for IUFD.
"We are committed to providing women and their families with important information regarding the cause of fetal loss as well as the recurrence risk for further pregnancies," added Mr. McDonough. "Data show that approximately half of all first trimester miscarriages are due to a fetal chromosomal abnormality; however, conventional cytogenetic analysis, such as karyotyping and fluorescence in situ hybridization (FISH), often proves to be very disappointing to patients due to high failure rates, long turnaround times and limited detection capabilities from these traditional testing modalities. With microarray analysis, we have a
greater likelihood of providing results to women who have suffered a stillbirth in 10 to 12 days as opposed to the approximately three weeks required by karyotyping, which may not yield results. Microarray testing is clearly the best cytogenetic approach to IUFD analysis and CombiMatrix has built a reputation as one of the most experienced chromosomal microarray laboratories in the U.S., having performed more than 40,000 microarrays."
ACOG, in a Committee Opinion No. 581, December 2013, stated that when further cytogenetic analysis is desired in IUFD, microarray analysis on fetal tissue is recommended over karyotyping as it provides superior diagnostic power with results in more than 90% cases versus 60-80% with karyotyping. The Committee
Opinion also noted the ability of microarray analysis to detect a broader range of abnormalities with the added benefit of not requiring cell culture.
The use of microarray analysis over karyotyping is also supported by results from a clinical study conducted by the Stillbirth Collaborative Research Network. Following the analysis of samples from 532 stillbirths, the study authors concluded that microarray is more likely than karyotyping to provide a genetic diagnosis, primarily due to its success in detecting abnormalities without the need for live cells and in cases in which karyotyping results cannot be obtained. The study, "Karyotype Versus Microarray Testing for Genetic Anomalies after Stillbirth" Reddy, et al, was published in the New England Journal of Medicine (December 6, 2012).
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. 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 IUFD microarray 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 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.
President & CEO, CombiMatrix Corporation
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Source: CombiMatrix Corporation
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