BOSTON, Nov. 1, 2012 /PRNewswire/ -- Cartagenia, the world leader in providing genetic labs and clinicians software-based workflow support for variant assessment, lab reporting, and integration of diagnostic knowledge-bases, announced today that it has signed a license agreement for the Cartagenia BENCHlab CNV platform with CombiMatrix Corporation (Nasdaq: CBMX), a molecular diagnostics company.
Irvine, CA-based CombiMatrix is a CLIA-certified and CAP-accredited, publicly-owned commercial clinical laboratory offering DNA-based genomic testing services in the areas of prenatal and pediatric developmental disorders and oncology. CombiMatrix has established itself as an industry leader in microarray-based clinical testing via a core team of microarray-pioneering physicians, scientists and technicians and has a strong commitment to both client and patient-focused service.
BENCH will be used for the analysis, interpretation and reporting of microarray results in routine postnatal and prenatal settings. The flexible nature of the BENCH platform will allow it to be tailored to CombiMatrix's variant assessment and reporting workflow, significantly accelerating the interpretation and reporting process without disrupting the established operating procedures. Additionally, BENCH's architecture will allow integration and communication with existing IT systems at CombiMatrix.
Richard D. Hockett, Jr., M.D.,Chief Medical Officer at CombiMatrix remarked, "With our lab operations and test volumes growing, it made perfect sense to select the Cartagenia BENCH platform at this time. We already perform hundreds of microarray analyses per month and having recently expanded testing for the prenatal marketplace, that number will grow even more. The automation provided by BENCHlab CNV gives us the ability to grow our array throughput while providing significant savings in both analysis and interpretation time and staffing. Another deciding factor was that Cartagenia clearly positions its solutions for clinical use in contrast to other software packages."
"We are pleased and excited to be working with CombiMatrix," said Drew Arnold, Cartagenia's VP of Sales, North America. "Its selection of the BENCH platform is a strong validation of our approach and indicative of the efficiencies that BENCH can bring to diagnostic laboratories."
Cartagenia successfully went through the process of implementing an ISO-certified quality management system and has registered the BENCH platform for variant interpretation and reporting as a Class 1 Medical Device with the FDA.
"We want to provide a 'clinical grade' tool set to our customer and help labs building a reliable infrastructure for clinical use of high-throughput genomic technologies," Arnold added.
Cartagenia supplies diagnostic software, database systems, and related services to genetic labs and clinicians, enabling them to perform clinically relevant genetic analyses quickly and efficiently, and offer patients and careers high-quality genetic interpretation and counseling.
The Cartagenia BENCH platform is built in collaboration with genetics labs and clinical experts involved in routine medical practice. Because of this, BENCHlab CNV addresses the specific needs of genetic diagnostic labs and clinicians.
Cartagenia BENCHlab CNV is built using a certified ISO13485 Quality Management System and is marketed as an FDA regulated Class I Medical Device in the United States and as a Class I Medical Device in Europe in conformity with the essential requirements and provisions of the Council Directive 93/42/EEC concerning medical devices, and with the relevant harmonized standards EN ISO62304.
About CombiMatrix Corporation
CombiMatrix Corporation, through its wholly owned subsidiary, CombiMatrix Molecular Diagnostics, Inc. (CMDX), is a molecular diagnostics laboratory that offers DNA-based testing services to the prenatal, pediatric and oncology markets. The Company performs genetic testing utilizing Microarray, FISH, PCR and G-Band Chromosome Analysis. CMDX offers prenatal and pediatric testing services for the detection of abnormalities of genes at the DNA level beyond what can be identified through traditional technologies. CMDX was also the first commercial clinical laboratory in the United States to make comprehensive DNA-based genomic analysis of solid tumors, including breast, colon, lung, prostate and brain tumors, available to oncology patients and medical professionals. Additional information about CMDX is available at www.cmdiagnostics.com or by calling 1-800-710-0624.