CombiMatrix Launches Preimplantation Genetic Diagnostic Testing for Single Gene Disorders and Chromosomal Translocations
April 05 2016 - 6:00AM
CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics
company specializing in DNA-based testing services for prenatal and
postnatal developmental disorders and pre-implantation genetic
screening services, announces the launch of CombiPGD™ -
Preimplantation Genetic Diagnosis (PGD) for single gene disorders
and chromosomal translocations. CombiPGD is a test performed
prior to embryo implantation to help identify genetic defects
created through in vitro fertilization to prevent certain diseases
or disorders from being passed on to the child.
Assisted reproductive technology is typically
associated with infertility. However, some fertile couples whose
children are at risk for a specific genetic disease or hereditary
chromosomal abnormality choose to undergo in vitro fertilization in
order to perform PGD. CombiMatrix already offers CombiPGS™, which
is a test that may help decrease the rate of implantation failure
and miscarriage by allowing physicians to identify and transfer
chromosomally normal embryos.
“We are pleased to launch another incremental
revenue-producing test in the IVF market that meets a critical
clinical need. The CombiPGD test rounds out our IVF test offering,
where we also offer PGS testing, parental karyotyping and
miscarriage analysis testing,” said Mark McDonough, President and
Chief Executive Officer of CombiMatrix. “CombiPGD allows couples
who are at significant risk of having a child with a serious
disorder the opportunity to gain important information about their
embryos before implantation with the goal of implanting only those
embryos without the disease of concern.”
A number of different technologies are currently
being used for both PGD and PGS. In contrast to some of the older
approaches to PGD testing, the two major benefits of the CombiPGD
approach are its broad applicability and streamlined
implementation. Unlike the laborious processes of developing and
validating PCR probes for each individual disease gene, CombiMatrix
utilizes a genome-wide set of single nucleotide polymorphisms as
markers to “track” a gene with the mutation from parent to child.
This enables the test to be used for virtually any single gene
disorder and to replace the typical eight to 12 week waiting period
for test development to under three weeks.
“Most patients pursuing this technology in our
practice have been referred to us because they already have an
affected child, or they have recently discovered that they are
carriers of a genetic disease that they are at risk of transmitting
to their future children,” explained Matthew C. Goering, PhD,
Director of Clinical Embryology at the Center for Advanced
Reproductive Medicine at the University of Kansas and Assistant
Professor at the University of Kansas Department of Obstetrics and
Gynecology Division of Reproductive Endocrinology and
Infertility.
“In the last few years we have witnessed an
exponential rise in the use of carrier screening for inherited
genetic diseases among patients of reproductive age,” added Dr.
Goering. “This growth in procreative genetic screening, along with
improvements in the technology and success rates associated with
IVF and embryo biopsy, have led to a significant increase in the
demand for preimplantation genetic testing in our IVF
practice. Genetic testing of this type is inherently
challenging due to the astonishingly small size of the samples –
typically just a few cells from each embryo. Thus, as the
demand for this new technology has risen, so has the need for
high-quality, experienced, genetic diagnostic laboratories that
offer the service.” Dr. Goering is a member of CombiMatrix’
Scientific Advisory Board.
In 2015, CombiMatrix entered the infertility
market with a disruptive, patient-centered approach to test
pricing, including both a multi-cycle and per-embryo price
structure for PGS. Based on the success of this model and customer
adoption over the past year, CombiMatrix is now offering their PGD
testing with the same flexible options.
About CombiMatrix
CorporationCombiMatrix 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," "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: market acceptance of our
CombiPGD test; our ability 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; the outcome of pending
litigation; 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.
Company Contact: |
|
Investor Relations Contact: |
Mark McDonough |
|
LHA |
President & CEO, CombiMatrix
Corporation |
|
Jody Cain |
(949) 753-0624 |
|
(310) 691-7100 |
|
|
jcain@lhai.com |
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