Cartagenia Receives Canadian Medical Establishment License Company's Bench Suite of Genetics Information Management Solutions Now a Medical Device for Canadian Market
BOSTON and LEUVEN, Belgium, March 18, 2014 /PRNewswire/ -- Cartagenia, the world leader in software-based workflow support for variant assessment, lab reporting, and integration of diagnostic knowledge-bases, today announced that it has received a Canadian medical establishment license for its Cartagenia Bench platform. Cartagenia Bench is a cloud-based platform that allows genetics labs and clinicians to analyze, interpret, report and share genomic variants in routine clinical diagnostics.
Cartagenia CEO Herman Verrelst noted that this new license is testament to Cartagenia's commitment to the Bench platform being fit for clinical use - moreover, the platform in turn supports labs in meeting their regulatory and accreditation requirements, so they can maximally focus on their core business.
"We take great care in ensuring that our software is compliant and accredited, because it takes away the worry for our customer labs and clinics and helps them focus on their core responsibilities – dealing with increasing test volumes while maintaining high quality genetic testing and lab reports, and keep turnaround times fast," Verrelst said. "As a company, we strongly believe that solutions used in a clinical diagnostic setting should be available on the market as a Medical Device. Our customer labs and clinical geneticists need diagnostic-grade solutions for lab interpretation and reporting workflow automation. Our products provide a best-of-breed resource allowing clinical labs to fulfill their regulatory requirements as well as markedly improve their turnaround times for analysis and reports. For Cartagenia, this new approval opens up the important and growing Canadian market for Bench and we look forward to working closely with clinicians throughout North America."
Registration of its software as a Medical Device is part of Cartagenia's focus on supporting labs in clinical diagnostics, where accreditation, regulatory compliance and data protection are essential. Cartagenia has taken the necessary effort to comply with the Canadian PHIPA/PIPEDA regulations and its solutions comply with the United States HIPAA regulations. The Cartagenia Bench platform is CE marked, registered with the FDA as an exempt 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 built under a certified ISO 13485 Medical Device Quality Management System.
Cartagenia enables genetic labs to perform clinically relevant analyses quickly and efficiently. Cartagenia's solutions are rich in features, easy to use, secure, and work with diverse knowledge sources to integrate the interpretation of genomic variation in routine diagnostics. We are cloud-based and scalable, and integrated into the global genetics diagnostics ecosystem. We are a collaborative platform, built not only to collect, sort, and secure the rush of data, but to listen and help you analyze it quickly, efficiently, effectively, intelligently.
The Cartagenia Bench platform is built in collaboration with genetics labs and clinical experts involved in routine medical practice. Because of this, Bench Lab NGS addresses the specific needs of genetic diagnostic labs and clinicians.
Cartagenia Bench Lab is built using a certified ISO13485 Quality Management System and is registered with the FDA as an exempt 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.