CombiMatrix Comments on Additional Medical Policy Revisions to Reimburse for Recurrent Pregnancy Loss Testing
May 10 2016 - 6:00AM
CombiMatrix Corporation (NASDAQ:CBMX), a molecular diagnostics
company specializing in DNA-based testing services for
pre-implantation genetic diagnostics and screening, miscarriage
analysis, prenatal and pediatric diagnostics, noted that within the
past two weeks the following managed care companies have revised
their medical policies for genetic testing of fetal tissue as
medically necessary for the evaluation of pregnancy loss in
patients in specific cases. The revised medical policies state:
“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.”
As of May 1, 2016, the following plans have also
revised their policies:
- Blue Shield of California
- Blue Cross Blue Shield of Florida
- Horizon Blue Cross Blue Shield of New Jersey
- BlueShield of Northeastern New York
- Blue Cross Blue Shield of Massachusetts
- Blue Cross Blue Shield of Kansas City
The revised medical policy guidelines for these
health plans to reimburse for diagnostic testing for miscarriage or
intrauterine fetal demise (IUFD) where genetic analysis of the
embryo, fetus or stillborn infant is indicated are based on
guidelines from several reproductive health organizations,
including the American Society for Reproductive Medicine (ASRM,
2013; ASRM, 2012), the National Society of Genetic Counselors
(Laurino, 2005) and the American College of Obstetrics and
Gynecology (ACOG, 2009).
“We believe that the continuing stream of health
plans reversing their medical policy decisions in favor of
reimbursing for recurrent pregnancy loss testing is a positive step
for women and their families in the decision-making process about
pregnancy. It is also a positive change for CombiMatrix, as
miscarriage analysis testing is the fastest growing segment of our
business,” said Mark McDonough, President and Chief Executive
Officer of CombiMatrix.
“California is our second largest market, so we
are very pleased to see that a policy there has been revised, as
well as policies for health plans in five additional states,” added
Mr. McDonough. “We now know that 13 health plans just this year
have reversed their prior decisions in favor of reimbursement for
recurrent pregnancy loss testing. In addition to revised guidelines
by several leading reproductive health organizations, we attribute
this trend to the growing body of clinical evidence in support of
miscarriage analysis testing.”
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 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. 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: adoption and market
acceptance of our IUFD microarray test offering, our ability to 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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