GeneDx Growing Array CGH Testing Volumes to 100,000 Tests a Year; Relies on Cartagenia Bench Lab CNV Platform for Automated Variant Assessment and Reporting

BOSTON and LEUVEN, Belgium and GAITHERSBURG, Md., Oct. 20, 2014 /PRNewswire/ -- GeneDx, leading clinical genetic testing provider for rare hereditary disorders, and Cartagenia, leader in providing genetic labs and clinicians with software-based workflow support for variant assessment, lab reporting, and integration of diagnostic knowledge-bases, jointly announced today that GeneDx has grown its diagnostic array test volumes over the past year to an average of 4,000 tests per month, hereby relying on Cartagenia's Bench Lab CNV platform. GeneDx anticipates a similar increase in volume over the coming 12 months.

GeneDx and Cartagenia have been collaborating since 2010 with a continued focus on automation and standardization of the routine diagnostic testing workflow.

Dean Gaalaas, GeneDx COO, states, "With volumes ramping up, we wanted to avoid manually investigating genomic variants as much as possible. Cartagenia Bench allowed us to build and validate variant assessment pipelines in line with our Standard Operating Procedures on how we assess variants and report on them. This really has saved a lot of time in a routine setting. Automation, standardization and integration have really allowed us to grow to these volumes – and have given us a sound basis to scale further while maintaining best quality of service to our customers."

Steven Van Vooren, scientific founder at Cartagenia, says: "Building a robust clinical data analysis and reporting pipeline only works if information flows seamlessly between the different systems involved, end to end. This encompasses running the assay, capturing the results, managing the interpretation workflow, sign-off, all the way to generating the final report which is then integrated into the internal LIMS and reporting systems. A first essential requirement was a successful automation of both variant assessment protocols and lab report generation. Secondly, GeneDx and Cartagenia have worked to directly integrate Bench with the lab's information management systems using Bench Connector, which is not just a time-saver – the direct communication between the different IT systems also avoids human error."

Drew Arnold, VP of Sales and Business Development in North America, said the marked success of the Bench platform at GeneDx underscores a true need for clinical-grade tools for automation of both lab variant assessment and reporting in the rapidly growing genetic diagnostics market.

"It is very rewarding to see the successful growth at one of our marquee customers here in the US," Arnold said. "We believe GeneDx is representative of the strong drive towards professionalisation and scaling in the diagnostic testing market – and we are keen to continue to work with them to grow their business further."

About Cartagenia

Cartagenia supplies diagnostic support 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 carers high-quality genetic interpretation and counselling.

Cartagenia Bench Lab allows automation of variant assessment protocols and lab report generation for structural and molecular variant assays such as Arrays, Sanger and Next Generation Sequencing. It supports communication with referring physicians, allows labs and clinicians to put variants in their clinical context, and supports confident data sharing.

The Cartagenia Bench platform is built in collaboration with genetics labs and clinical experts involved in routine medical  practice. Because of this, Bench Lab addresses the specific needs of genetic diagnostic labs and clinicians.

Cartagenia Bench 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.

www.cartagenia.com

Contact:

CARTAGENIA
Herman Verrelst
CEO Cartagenia
Technologielaan 3
3001 Leuven
T : +32 16 40 40 66
E : [email protected]
www.cartagenia.com

Allen & Caron
Len Hall
VP Media Relations
T : 1 949 474 4300
E : [email protected]
www.allencaron.com

SOURCE Cartagenia