CombiMatrix Comments on Revised Reimbursement Policies for Recurrent Pregnancy Loss
February 11 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, observed recent revisions in medical policies
to include reimbursement for recurrent pregnancy loss by two health
plans in the Blue Cross Blue Shield (BCBS) system. CombiMatrix
President and Chief Executive Officer Mark McDonough commented as
follows:
“A growing accumulation of published data
supports the use of chromosomal microarray testing to address the
high prevalence and emotionally charged issue of women suffering
multiple miscarriages. We believe that policy revisions by
certain providers show the healthcare community’s growing
recognition of the importance of helping women and their families
understand the reasons behind recurrent pregnancy loss. CombiMatrix
is focused on this growth market by offering a chromosomal
microarray test for miscarriage analysis that offers competitive
advantages to older technologies like karyotyping. We make
available our Genetic Counseling team to providers as well in order
to assist physicians and families in decision making. We view
policy changes such as these as having the potential for a positive
impact on our business and we believe more plans will adopt similar
coverage policies based on the supporting data.”
The health plans in the BCBS system that
recently announced revisions to include recurrent pregnancy loss
are:
BCBS of North Dakota:
Chromosomal microarray analysis of fetal tissue may
be considered medically necessary for the evaluation of pregnancy
loss in patients with indications for genetic analysis of the
embryo or fetus as follows:
- In cases of pregnancy loss at 20 weeks of gestation or earlier
when there is a maternal history of recurrent miscarriage (defined
as a history of 2 or more failed pregnancies); or
- In all cases of pregnancy loss after 20 weeks of
gestation.
BCBS of North Dakota Corporate Medical Policy: “Chromosomal
Microarray Analysis for the Evaluation of Pregnancy Loss”
https://bb.thor.org/BulletinBoard/ViewFile.aspx?param=BulletinsBlue_Cross_Blue_Shield_ND_Medical_PolicyChromosomal_Microarray_Analysis_for_the_Evaluation_of_Pregnancy_Loss.htm
BCBS of South Carolina: Chromosomal microarray
analysis of fetal tissue may be considered MEDICALLY
NECESSARY for the evaluation of pregnancy loss in patients
with indications for genetic analysis of the embryo or fetus (see
Policy Guidelines - CAM 204122, “Chromosomal Microarray
Analysis”).Policy Guidelines: Genetic
testing may be indicated (if desired by parents):
- In cases of pregnancy loss at 20 weeks of gestation or earlier
when there is a maternal history of recurrent miscarriage (defined
as a history of 2 or more failed pregnancies); or
- In all cases of pregnancy loss after 20 weeks of gestation
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 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: whether or not changes in
coverage policies by various third-party providers will positively
impact our future operations; whether or not other third-party
providers will adopt similar coverage policies; 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: Mark
McDonoughPresident & CEO, CombiMatrix Corporation(949)
753-0624
Investor Relations Contact:LHA Jody Cain (310)
691-7100 jcain@lhai.com
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