ACOG and SMFM Update Practice Bulletins Recommending Prenatal Genetic Assessment for All Pregnant Women Regardless of Age or ...
23 Marzo 2016 - 4:00AM
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 that the American College of
Obstetricians and Gynecologists (ACOG) and the Society for
Maternal-Fetal Medicine (SMFM) recently updated their practice
bulletins recommending that all pregnant women regardless of age or
other risk factors be offered prenatal assessment for aneuploidy
and other genetic disorders. The updated information for
prenatal testing was issued in Practice Bulletins “Prenatal
Diagnostic Testing for Genetic Disorders” (Number 162, May 2016)
and “Screening or Fetal Aneuploidy (Number 163, May 2016).
Among the updates, ACOG and SMFM significantly
lowered the procedure-related risk of pregnancy loss for chorionic
villous sampling (CVS) to 1 in 455 and for amniocentesis to 1 in
900, based on recent meta-analysis of available data. These revised
risk assessments are expected to substantially diminish patient
concerns and increased acceptance of prenatal invasive testing for
any risk or age category. The new guidelines also recommend
that chromosomal microarray analysis should be the primary test for
invasive prenatal assessment, as well as for fetal death and
stillbirth analysis, due its ability to detect abnormalities that
may be missed by other diagnostic methods.
Additional key points in the practice bulletin
guidelines include the value of providing pregnant women with
pre-test education and post-test counseling, as well as the
necessity to conduct confirmatory testing following positive
screening for genetic abnormalities, and a recommendation against
the use of prenatal screening in detecting microdeletions due to
the limited validation data. The bulletins also reinforce
ACOG and SMFM’s prior position that due to the potential for
false-positive results, screening tests for aneuploidies such as
Down syndrome are not a substitute for diagnostic testing.
“ACOG and SMFM are taking important steps with
these updated practice bulletins to provide a path by which
physicians and their patients can make better informed decisions
about pregnancies,” said CombiMatrix President and Chief Executive
Officer, Mark McDonough. “The new analysis indicates that CVS
and amniocentesis are far less risky to pregnancy loss than
previously believed by these associations as well as within the
diagnostic industry. Importantly, the bulletins reemphasize
the necessity for confirmatory diagnostic testing as a reflex when
screening tests indicate positive results for fetal genetic
abnormalities and further points to chromosomal microarray
analysis, which is offered by CombiMatrix, as the recommended
test. We feel the recent changes to the ACOG Bulletin will
help patients and physicians to be better educated on the reduced
risk of miscarriage from invasive procedures, thus potentially
leading to increased ordering of more comprehensive diagnostic
testing.
“We commend ACOG and SMFM for recognizing the
value of providing prenatal genetic counseling to physicians and
their patients,” McDonough added. “I’m very proud of our
high-touch focus at CombiMatrix and in the quality of our tests,
our technological capabilities and our genetic counselors that
enable us to provide vital information in a compassionate way to
the physicians and patients we service.”
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 prenatal diagnostics, miscarriage analysis for
recurrent pregnancy loss, pediatric genetics and pre-implantation
genetic screening, 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. 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: whether revised ACOG and
SMFM guidelines will lead to a greater number of invasive
diagnostic tests ordered; 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; 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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