Six Months After Publication of Key Studies, CombiMatrix Sees Growth in Prenatal Testing Adoption
18 Junio 2013 - 5:00AM
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics
company performing DNA-based testing services for developmental
disorders and cancer diagnostics, today announced that its volumes
of prenatal testing have shown a significant uptick since data from
two National Institutes of Health (NIH) studies showed the value of
chromosomal microarray analysis (CMA).
The larger study (published in conjunction with the National
Institute of Child Health and Human Development [NICHD]), which had
over 4,400 patients enrolled, was published in the New England
Journal of Medicine (NEMJ) in December 2012 and presented at the
annual meeting of the Society for Maternal-Fetal Medicine in
February, concluded that CMA identified additional clinically
significant genetic abnormalities compared to traditional
karyotyping when testing prenatal samples. CombiMatrix is the only
publicly-traded company that specializes in CMA.
"The NICHD study clearly demonstrated the superiority of
microarrays over traditional karyotyping," said Jim Goldberg, MD of
San Francisco Perinatal Associates. "Due to the strength of
the data in that study, we now counsel patients on the availability
of microarray testing and offer this option to them as a first tier
test." Dr. Goldberg reiterated, "The clinical utility of
microarrays are their ability to detect chromosomal copy number
abnormalities that are missed by traditional karyotyping. The
accuracy of microarray, coupled with the test's fast
turn-around-time, helps reduce patients' anxiety by providing
comprehensive results as we move toward this new standard of
care."
Some clinicians have been slow to adopt microarray testing
because of concerns about variants of uncertain significance
(VOUS). Dr. Goldberg emphasizes, "These types of findings are a
routine part of prenatal diagnosis as a whole. Microarray testing
identifies clinically significant chromosomal abnormalities that
have gone undetected by karyotyping. As we learn more about
these undetected chromosomal copy number changes, clinicians will
become more comfortable explaining their significance to
patients."
At CombiMatrix, volumes of testing for both miscarriage
management and prenatal genetic testing have grown rapidly, as
previously reported in the Company's first quarter 2013 earnings
release.
"We believe that the very clear data published in the NEJM on
both stillbirths and on invasive procedures highlight the value of
CMA and is driving the uptick in our prenatal testing volumes,"
CombiMatrix President and CEO Mark McDonough said. "The data has
generated momentum that tells us, first, we made the correct
decision when we decided to make a strategic shift to focus on the
developmental markets where CMA is becoming the standard of care.
But second, it also shows that we continue to take market share
from our competitors. We are excited and well positioned to help
drive the conversion from karyotyping to microarrays over the next
several quarters."
About CombiMatrix Corporation
CombiMatrix Corporation, through its wholly owned subsidiary,
CombiMatrix Molecular Diagnostics, Inc. (CMDX), is a molecular
diagnostics laboratory which offers DNA-based testing services to
the prenatal, pediatric and oncology markets. The Company
performs genetic testing utilizing Microarray, FISH, PCR and G-Band
Chromosome Analysis. CMDX offers prenatal and pediatric
testing services for the detection of abnormalities of genes at the
DNA level beyond what can be identified through traditional
technologies. CMDX was also the first commercial clinical
laboratory in the United States to make comprehensive DNA-based
genomic analysis of solid tumors, including breast, colon, lung,
prostate and brain tumors, available to oncology patients and
medical professionals. Additional information about CMDX is
available at www.cmdiagnostics.com or by calling
1-800-710-0624.
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," "objective," similar
expressions, and variations or negatives of these words and
include, but are not limited to, statements regarding the
advantages and efficacy of CMA over standard
karyotyping. 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: market
acceptance of CMA as a preferred method over karyotyping; the rate
of transition to CMA from karyotyping; our ability to successfully
expand the base of our customers and strategic partners, add to the
menu of our diagnostic tests in both of our primary markets,
develop and introduce new tests and related reports, optimize the
reimbursements received for our testing services, and increase
operating margins by improving overall productivity and expanding
sales volumes; our ability to successfully accelerate sales, allow
access to samples earlier in the testing continuum, steadily
increase the size of our customer rosters in both developmental
medicine and oncology; our ability to attract and retain a
qualified sales force; rapid technological change in our markets;
changes in demand for our future products; 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
Tel (949) 753-0624
Media Contact:
Len Hall
VP, Media Relations
Allen & Caron
Tel (949) 474-4300
len@allencaron.com
Investor Relations Contact:
John Baldissera
BPC Financial Marketing
Tel (800) 368-1217
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