CombiMatrix Announces Commercial Launch of Microarray Testing for Stillbirth Analysis
January 28 2016 - 6:00AM
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).
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. 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.
Company Contact:
Mark McDonough
President & CEO, CombiMatrix Corporation
(949) 753-0624
Investor Relations Contact:
LHA
Jody Cain
(310) 691-7100
jcain@lhai.com
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