CombiMatrix Comments on Revised Reimbursement Policies for Recurrent Pregnancy Loss

Feb. 11, 2016 6:00 am

IRVINE, Calif., Feb. 11, 2016 (GLOBE NEWSWIRE) -- 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”\Blue_Cross_Blue_Shield_ND_Medical_Policy\Chromosomal_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 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 McDonough
President & CEO, CombiMatrix Corporation
(949) 753-0624

Investor Relations Contact:
Jody Cain
(310) 691-7100

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February 11, 2016 - 6:00 AM EST

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