CombiMatrix’s Pre-Implantation Genetic Screening by Next Generation Sequencing Granted Conditional Approval from New York S...
29 November 2016 - 10:00PM
CombiMatrix Corporation (NASDAQ:CBMX), a family health molecular
diagnostics company specializing in DNA-based reproductive health
and pediatric testing services, announces that its pre-implantation
genetic screening (PGS) by next generation sequencing (NGS) test
has received conditional approval from the New York State
Department of Health. The CombiPGS™ test is for women
undergoing in vitro fertilization (IVF) and screens embryo biopsy
cells for chromosomal abnormalities prior to implantation of the
embryo. The test assists in maximizing the chance of
successful implantation and pregnancy progression, while decreasing
the likelihood of miscarriage.
“We launched CombiPGS using NGS technology in
June of this year as NGS allows for unequaled accuracy and
sensitivity in the detection of whole chromosome and segmental
aneuploidies, which is crucial in providing the highest quality
results for this test,” said Mark McDonough, President and Chief
Executive Officer of CombiMatrix. “CombiPGS by NGS is an
important upgrade to our portfolio of reproductive health tests and
we are pleased by the strong reception it has received from
reproductive endocrinologist and IVF physicians who are key call
points for this test.
“We are now marketing CombiPGS by NGS in New
York State, which ranks second in the total number of IVF cycles
performed nationally each year. With this approval, physicians and
their patients across the U.S. can access our full portfolio of
reproductive health tests and capitalize on our industry-leading
experience and our high-touch clinical support. For
CombiMatrix, this is a promising cash-pay market that we estimate
to be approximately $125 million annually in the U.S. and
growing. We expect CombiPGS will be an important contributor
to revenue as we target cash flow breakeven by the fourth quarter
of 2017."
About CombiMatrix
Corporation
CombiMatrix Corporation provides best-in-class
molecular diagnostic solutions and comprehensive clinical support
to foster the highest quality in patient care. CombiMatrix
specializes in pre-implantation genetic diagnostics and screening,
prenatal diagnosis, miscarriage analysis and pediatric
developmental disorders, offering DNA-based testing for the
detection of genetic abnormalities beyond what can be identified
through traditional methodologies. Our testing focuses on advanced
technologies, including single nucleotide polymorphism (“SNP”)
chromosomal microarray analysis (“CMA”), next generation sequencing
(“NGS”), fluorescent in situ hybridization (“FISH”) and high
resolution karyotyping. 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,"
“approximtates,” "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 and include, but are not
limited to, statements regarding projected results of operations,
including projected cash flow-positive operating results,
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: market acceptance of our
NGS tests in the State of New York and elsewhere, our estimates of
total market sizes for the tests that we offer; our ability to grow
revenue and improve gross margin; delays in achieving cash
flow-positive operating results; the risk that test volumes and
reimbursements level off or decline; the risk that payors decide to
not cover our tests or to reduce the amounts they are willing to
pay for our tests; the risk that we will not be able to grow our
business as quickly as we need to; the inability to raise capital;
the loss of members of our sales force; our ability to successfully
expand the base of our customers, 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 all of
our genetic testing markets; our ability to attract and retain
a qualified sales force in wider geographies; our ability to ramp
production from our sales; 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.
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Investor Contact: |
Mark McDonough |
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LHA |
President & CEO, CombiMatrix Corporation |
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Jody Cain |
(949) 753-0624 |
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(310) 691-7100 |
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jcain@lhai.com |
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