New England Journal of Medicine Article Supports Importance of Follow-up Diagnostic Testing Following Positive Noninvasive Pr...
April 10 2015 - 8:00AM
CombiMatrix Corporation (Nasdaq:CBMX), a molecular diagnostics
company specializing in DNA-based diagnostic services for prenatal,
postnatal, and pre-implantation genetic testing today announced
that an article and a letter to the editor published online on
April 1, 2015 in the New England Journal of Medicine support the
need for follow-up confirmatory diagnostic testing following a
positive noninvasive prenatal screening test (NIPT) result.
In a prospective, multicenter study of 15,841 women, Norton et
al., (April 1, 2015 DOI: doi/pdf/10.1056/NEJMoa1407349) found that
despite NIPT's high sensitivity and specificity compared to
standard screening, the positive predictive value (i.e. the chance
that a positive result accurately identifies an affected pregnancy)
of NIPT is limited, making it essential to follow up a positive
NIPT result with confirmatory prenatal diagnostic testing. In a
letter to the editor in the same issue, Cheung, Patel, and Leung
(April 1, 2015DOI: 10.1056/NEJMc1412222) discussed some of the
biological causes of the inherent limitations of NIPT and recommend
that such assays be referred to only as "DNA-based noninvasive
prenatal screening" to emphasize the screening nature of the
testing.
"Noninvasive prenatal testing is an excellent tool to screen for
chromosomal abnormalities in a developing fetus," said Mark
McDonough, President and Chief Executive Officer of CombiMatrix.
"That said, these tests are screening tests and it is very
important that positive results be confirmed by invasive prenatal
diagnostic testing so that the most informed clinical decision can
be made by the patient and her physician. In our own experience as
a provider of prenatal diagnostic testing services, we have
witnessed many cases in which our diagnostic tests do not confirm
the abnormality suspected by NIPT, thereby circumventing decisions
that may have been made based on a screening test alone. We believe
this is why, after evaluating numerous studies, the American
College of Obstetricians and Gynecologists (ACOG) has issued a
Committee Opinion advising that invasive prenatal diagnostic
testing be performed to confirm any positive NIPT results."
About CombiMatrix Corporation
CombiMatrix Corporation provides valuable molecular diagnostic
solutions and comprehensive clinical support for the highest
quality of care – specializing in pre-implantation genetic
screening, 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: market acceptance of our
mircroarray diagnostic tests to confirm positive NIPT results; 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, steadily increase the size of our
customer rosters; our ability to attract and retain a qualified
sales force; 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 Contact:
Robert Flamm, Ph.D.
Russo Partners, LLC
(212) 845-4226
robert.flamm@russopartnersllc.com
Media Contact:
David Schull or Lena Evans
Russo Partners LLC
(212) 845-4271
david.schull@russopartnersllc.com
lena.evans@russopartnersllc.com
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