CombiMatrix Study Published in Genetics in Medicine Establishes the Superior Diagnostic Value of Microarray Analysis over Kar...
June 24 2016 - 6:00AM
CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics
company specializing in DNA-based reproductive health and pediatric
testing services, announces the publication of data from a large
retrospective study demonstrating a high success rate and superior
diagnostic power of chromosomal microarray analysis for recurrent
pregnancy loss testing. The study was conducted by
CombiMatrix, a leading provider of microarray testing for
miscarriage analysis.
In the largest study of its kind involving
pregnancy loss, more than 8,000 consecutive products of conception
(POC) samples received by CombiMatrix over a 44-month period were
analyzed and results were successfully obtained for more than 90%
of the cases. This compares with reported success rates of between
60-80% for samples evaluated using the traditional testing method
of karyotyping. Importantly, clinically significant abnormalities
were identified in 53.7% of samples, 95% of which were considered
causative of the pregnancy loss. Results of the study are
featured in “Comprehensive genetic analysis of pregnancy loss by
chromosomal microarrays, outcome, benefits, and challenges,” (T.
Sahoo, et al) in the advanced online publication of peer-reviewed
Genetics in Medicine (2016) doi:10.1038/gim.2016.69.
“The market for miscarriage analysis has
increased dramatically over the past few years and we expect that
these outstanding clinical results will further drive demand and
payer reimbursement for the use of microarray analysis for this
testing,” said Mark McDonough, President and Chief Executive
Officer of CombiMatrix. “We are proud of our position as a
commercial and scientific leader in the estimated $300 million
annual U.S. market for miscarriage analysis testing. This is
the fastest growing segment of our business and is an important
contributor to our revenue growth and path to profitability.”
“Karyotyping has been the standard practice in
recurrent pregnancy loss testing, but has major drawbacks in terms
of high failure rates (20-40% cases), long turnaround times and a
high risk of maternal cell contamination during culture that can
significantly confound accurate results,” said study author
Trilochan Sahoo, M.D., FACMG, CombiMatrix’s Vice President of
Clinical Affairs and Director of Cytogenetics. “Our high success
rate with evaluating challenging POC samples includes both fresh
and formalin-fixed, paraffin-embedded (FFPE) samples, thus
providing significant advantages and options to clinicians and
providers. Further, the ability of single nucleotide
polymorphism (SNP)-based microarray analysis to identify
aneuploidy, polyploidy, whole-genome homozygosity, segmental
genomic imbalances and maternal cell contamination maximizes
sensitivity and decreases the number of false-negative
results.”
“The information provided by microarray analysis
performed by CombiMatrix has far surpassed our hospital’s
expectations and has allowed our clinicians to provide the answers
their patients seek,” said Mandolin Ziadie, MD, Pathologist at
Memorial Regional Hospital and CombiMatrix Scientific Advisor.
“Use of the test has resulted in improved patient care,
pregnancy planning and counseling. Most importantly, the data
makes a notable contribution to our current understanding of the
frequency and nature of both common and unusual genetic
abnormalities that lead to or contribute to pregnancy loss. I can
foresee this information as being an important guide for clinicians
and their patients, and as an important source of data for research
aimed at improving fertility and better understanding the causes of
recurrent pregnancy loss.”
“Recurrent pregnancy loss is an emotionally
charged problem and is incredibly painful for the victims who
suffer these losses,” added McDonough. “It is also a significant
medical dilemma, as an estimated 15-20% of all clinically
recognized pregnancies end in miscarriage. Providing accurate and
timely diagnoses could have positive impact on patient counseling
and management. We intend to continue driving scientific
advancement to help better refine our understanding of the factors
behind recurrent pregnancy loss. It is our passion and
objective to provide valuable information to families that will
support their planning.
“We believe the results of this study will
further educate the MFM/OB/RE physician community on the clinical
importance of miscarriage analysis testing. We are pleased to
report that the mounting data supporting use of microarray analysis
as the preferred technology for testing is being increasingly
recognized by health providers. So far in 2016, 15 insurance
providers, including Cigna Health Services and multiple plans in
the Blue Cross Blue Shield network, have revised their medical
policies to include microarray testing as medically necessary for
the evaluation of recurrent pregnancy loss.”
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 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: whether adoption and
market acceptance of our microarray test offerings for miscarriage
analysis will increase or whether third-party payors will expand
coverage for this test based on published studies or clinical data,
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 |
|
jcain@lhai.com |
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