New Data From Multi-Year Study of Pregnancy Loss Support Efficacy and Diagnostic Power of CombiMatrix’s Chromosomal Micro...
January 06 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 that
new data from a multi-year study support the efficacy of SNP-based
chromosomal microarray analysis (CMA) in detecting chromosomal
imbalances. Data from the study conducted by CombiMatrix will
be presented by Trilochan Sahoo, M.D., FACMG, the company’s Vice
President of Clinical Affairs and Director of Cytogenetics, at the
World Congress on Recurrent Pregnancy Loss in Cannes, France on
January 16, 2016.
“With successful analysis and results from more
than 90% of products of conception samples, our findings show that
CMA is the most effective diagnostic test for identifying
chromosomal abnormalities in these samples,” said Dr. Sahoo.
“CMA testing improves diagnostic sensitivity in both fresh and
formalin-fixed, paraffin-embedded (FFPE) samples compared with
analysis by karyotyping, which may fail to produce results in 20%
to 40% of cases.”
The study was conducted over a 44-month period
reviewing data from more than 8,000 products of conception samples
comprised of both fresh (76.4%) and FFPE (22.4%) samples. The
majority of samples (83%) were ascertained for recurrent pregnancy
loss and/or spontaneous abortion. Additionally, 81.6% of
samples were evaluated using a whole genome SNP-based CMA array and
the remainder by array-CGH (comparative genomic
hybridization). Highlights of the study include:
- Successful analysis of 91.1% of samples (92.4% of fresh and
86.4% of FFPE)
- Clinically significant abnormalities detected in 53.7% of
successfully analyzed samples, of which 95% were causative
“These impressive, large-scale study results
support our SNP-based CMA as a powerful platform to identify
aneuploidy, polyploidy, segmental genomic imbalances and maternal
cell contamination, and build on our expertise as a world leader in
miscarriage analysis,” said Mark McDonough, President and Chief
Executive Officer of CombiMatrix. “This is a rapidly growing market
opportunity for CombiMatrix with over one million women suffering
miscarriages in the United States annually. With increased
diagnostic sensitivity, CMA reduces the occurrence of false
negative results. Importantly, an enhanced understanding from using
CMA of the cause and recurrence risks of fetal loss helps patients
make better informed family planning decisions.”
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: 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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