EZValidation™ Online Tool Helps Validate Clinical Molecular Assays

The new EZValidation Online Tool, helps clinical laboratories standardize their verification and validation requirements and eases adoption of new molecular tests for labs in the United States and Europe.

Life Technologies' EZValidation Online Tool is a web-based program designed to assist laboratories in identifying molecular assay verification or validation requirements to comply with CLIA accreditation requirements in the U.S. and meet ISO standards in Europe. Compliance with CLIA requirements is necessary for any laboratory that reports patient results for clinical purposes in the United States.

Specifically, the program helps laboratories identify verification and validation steps required to implement new molecular tests. The performance and accuracy of molecular tests is enhanced through the use of well-characterized quality control materials.

The EZValidation Online Tool, which may be configured to work with Life Technologies' AcroMetrix quality control materials, helps labs establish an easy-to-use workflow from protocol development through the final report generation. The tool provides a simplified path for adopting new molecular assays through ISO 15189, CLIA, CAP (College of American Pathologists) and New York State guidelines. The online tool is also updateable for new guidelines and tests as they are developed.

'EZValidation's Online Tool will help clinical labs maintain their compliance and adopt new molecular tests to foster the accuracy, reliability and timeliness of patients' results,' said Kimberlee Caple, Head of Molecular Medicine Products at Life Technologies. 'The clinical laboratory market is the front line for the adoption of molecular medicine in healthcare, and EZValidation helps those facilities incorporate molecular assays more efficiently, accurately and effectively.'