CombiMatrix's SNP-Based Miscarriage Analysis Test Granted Conditional Approval From New York State Department of Health
July 31 2014 - 8:00AM
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics
company performing DNA-based testing services for developmental
disorders and cancer diagnostics, today announced that its
SNP-based chromosomal microarray analysis (CMA) test for
miscarriage analysis, the CombiSNP™ Array for Pregnancy Loss, or
products of conception, has received conditional approval from the
New York Department of Health (NYDOH). This approval is for testing
on fresh and formalin fixed paraffin embedded (FFPE) patient
samples. Last year, the Company's CMA miscarriage analysis test for
fresh tissue was conditionally-approved by NYDOH.
Over one-half of all first trimester pregnancy losses are due to
chromosomal abnormalities. Older technologies, such as Karyotyping,
are subject to frequent cell culture failure, but microarray
testing is DNA-based, and does not require cell culturing. Unlike
older microarray methodologies, the CombiSNP™ array can identify
triploidy and molar pregnancies as well. In addition, the CombiSNP™
Array for Pregnancy Loss can use FFPE samples so the analysis can
be performed if no fresh tissue is available.
"The availability of this SNP-based CMA test provides New York
physicians the flexibility to either use fresh tissue or stored
FFPE tissue when fresh tissue is not available," said Mark
McDonough, chief executive officer of CombiMatrix. "In addition,
this conditional license is the second this month, following
conditional approval to market our CombiSNP™ CMA test for pediatric
analysis, and the third since last year that we have received from
the New York Department of Health. This approval enables
CombiMatrix to market both of our CMA miscarriage analysis tests in
New York state. We view these conditional approvals as validation
of our regulatory and clinical capabilities to bring new test
solutions to our customers."
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 SNP-based
miscarriage analysis 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
Tel (212) 845-4271
david.schull@russopartnersllc.com
lena.evans@russopartnersllc.com
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