CombiMatrix's Array for Pre-Implantation Genetic Screening Granted Conditional Approval From New York State Department of Hea...
10 December 2015 - 10:00PM
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, today announced
that its CombiPGS™ test for women undergoing in vitro fertilization
(IVF) has received conditional approval from the New York State
Department of Health. CombiPGS allows couples to screen embryo
biopsy cells for chromosomal abnormalities prior to implantation of
the embryo in order to maximize the chance of successful
implantation and pregnancy progression and to decrease the
likelihood of a miscarriage.
"The demand for our CombiPGS test across the country has been
strong since our launch in early 2015. We are very excited to now
offer this service in New York State, which ranks second only to
California in the total number of IVF cycles performed nationally
each year," said Mark McDonough, President and Chief Executive
Officer of CombiMatrix. "California has been our top producing
state for the adoption of CombiPGS and we are optimistic that we
can replicate that success in New York. It is worth noting that
CombiMatrix is the first national commercial diagnostic laboratory
to offer PGS testing with per-embryo pricing, allowing patients to
only pay for those embryos being tested.
"With CombiPGS, we are applying our industry-leading experience
with microarray technology and our high-touch clinical support to
what we believe is a lucrative cash-pay market that is estimated to
be $75 million annually and growing," added McDonough. "As we have
highlighted before, the reproductive endocrinologist/IVF physician
is an important call point for us. We now offer our fastest growing
product, the CombiSNP™ Array for Pregnancy Loss, CombiPGS, and our
Parental Karyotyping tests to these clinics and are leveraging our
established commercial infrastructure and expertise to grow these
three product lines nationally.
"We believe our comprehensive portfolio of prenatal testing
services available to physicians in the New York market enables us
to maximize the efficiency of our sales force in this significant
market. This past summer, we invested in two sales representatives
in New York to capitalize on this opportunity. Over the past two
years, we have been successful driving our test adoption in the New
York market for miscarriage analysis, and we see a high potential
for growth with CombiPGS," concluded McDonough.
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,"
"optimistic," "continue," "ongoing," similar expressions, and
variations or negatives of these words and include, but are not
limited to, statements regarding projected results of operations
and management's future business, operational and strategic plans,
recruiting efforts and test menu expansion. 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
successfully market our CombiPGS and other diagnostic test
offerings in the State of New York, to obtain final approval from
the State of New York for our CombiPGS, to successfully expand the
base of our customers and strategic partners, 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; 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
(949) 753-0624
Investor Relations Contact:
LHA
Jody Cain
(310) 691-7100
jcain@lhai.com
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