New Data From Multi-Year Study of Pregnancy Loss Support Efficacy and Diagnostic Power of CombiMatrix's Chromosomal Microarray Analysis

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CombiMatrix Corporation
CBMX
, a molecular diagnostics company specializing in DNA-based testing services for prenatal, miscarriage analysis and postnatal developmental disorders and pre-implantation genetic screening (PGS) services, announces that new data from a multi-year study support the efficacy of SNP-based chromosomal microarray analysis (CMA) in detecting chromosomal imbalances. Data from the study conducted by CombiMatrix will be presented by Trilochan Sahoo, M.D., FACMG, the company's Vice President of Clinical Affairs and Director of Cytogenetics, at the World Congress on Recurrent Pregnancy Loss in Cannes, France on January 16, 2016. "With successful analysis and results from more than 90% of products of conception samples, our findings show that CMA is the most effective diagnostic test for identifying chromosomal abnormalities in these samples," said Dr. Sahoo. "CMA testing improves diagnostic sensitivity in both fresh and formalin-fixed, paraffin-embedded (FFPE) samples compared with analysis by karyotyping, which may fail to produce results in 20% to 40% of cases." The study was conducted over a 44-month period reviewing data from more than 8,000 products of conception samples comprised of both fresh (76.4%) and FFPE (22.4%) samples. The majority of samples (83%) were ascertained for recurrent pregnancy loss and/or spontaneous abortion. Additionally, 81.6% of samples were evaluated using a whole genome SNP-based CMA array and the remainder by array-CGH (comparative genomic hybridization). Highlights of the study include: Successful analysis of 91.1% of samples (92.4% of fresh and 86.4% of FFPE) Clinically significant abnormalities detected in 53.7% of successfully analyzed samples, of which 95% were causative "These impressive, large-scale study results support our SNP-based CMA as a powerful platform to identify aneuploidy, polyploidy, segmental genomic imbalances and maternal cell contamination, and build on our expertise as a world leader in miscarriage analysis," said Mark McDonough, President and Chief Executive Officer of CombiMatrix. "This is a rapidly growing market opportunity for CombiMatrix with over one million women suffering miscarriages in the United States annually. With increased diagnostic sensitivity, CMA reduces the occurrence of false negative results. Importantly, an enhanced understanding from using CMA of the cause and recurrence risks of fetal loss helps patients make better informed family planning decisions."
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