CombiMatrix's Pediatric Development Disorders Analysis Test Granted Conditional Approval From New York State Department of He...
July 15 2014 - 7:00AM
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics
company performing DNA-based testing services for developmental
disorders and cancer diagnostics, today announced that its
chromosomal microarray analysis (CMA) test to identify development
disorders in pediatric patients, the CombiSNP™ Array for Pediatric
Analysis, has received conditional approval from the New York
Department of Health for testing on patient samples. In 2013, the
New York Department of Health granted CombiMatrix approval to
market its CombiSNP™ CMA test for miscarriage analysis.
CMA testing for pediatric development disorders, such as the
company's CombiSNP™ CMA test, is recommended by the American
College of Medical Genetics for individuals with developmental
delays, birth defects, physical deformities or autism or autism
spectrum disorder. Such tests enable parents and physicians to
determine whether the child's abnormality is caused by a genetic
defect. If so, the condition can be addressed in a number of ways
including watching for health conditions associated with the
abnormality, providing eligibility for services such as speech or
physical therapy and to evaluate the risk to future
pregnancies.
"Gaining the conditional license enables us to market and sell
the CombiSNP™ Array throughout New York State for pediatric
development disorders," said Mark McDonough, chief executive
officer of CombiMatrix. "We have focused our market development
activities on our miscarriage analysis test over the past year and
now we plan to expand our activity to address pediatric disorders.
Since last year, we have been selling directly to customers as well
as through distribution partnerships. In the meantime, we look
forward to working with the New York Department of Health to obtain
full approval for this important test to assist patients and their
physicians."
Under conditional approval, CombiMatrix will be able to market
the test in New York while the test is under Clinical Laboratory
Reference System review. Upon completion of the review, either the
test will receive full marketing approval or additional information
will be required in order to achieve final approval.
About CombiMatrix Corporation
CombiMatrix Corporation provides valuable molecular diagnostic
solutions and comprehensive clinical support for the highest
quality of care – specializing in miscarriage analysis, prenatal
and pediatric healthcare. CombiMatrix offers comprehensive testing
services for the detection of abnormalities of genes at the DNA
level beyond what can be identified through traditional
technologies. The Company performs genetic testing utilizing
microarray, FISH, PCR and G-Band chromosome analyses. Additional
information about CombiMatrix is available at www.combimatrix.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. 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: obtaining full approval from the NYDOH to sell pediatric
developmental disorders tests in New York State; 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
Investor Relations Contact:
Robert Flamm, Ph.D.
Russo Partners LLC
Tel (212) 845-4266
robert.flamm@russopartnersllc.com
Media Contact:
David Schull or Lena Evans
Russo Partners LLC
Allen & Caron
Tel (212) 845-4271
david.schull@russopartnersllc.com
lena.evans@russopartnersllc.com
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