Online Tool Helps Validate Clinical Molecular Assays

A new online tool helps clinical laboratories standardize their verification and validation requirements and eases adoption of new molecular tests.

The web-based program is designed to assist laboratories in identifying molecular assay verification or validation requirements to comply with clinical laboratory improvement amendments (CLIA) accreditation requirements in the United States and meet International Standards Organization (ISO) standards in Europe. Compliance with CLIA requirements is necessary for any laboratory that reports patient results for clinical purposes in the United States.

The EZValidation Online Tool, which was launched by Life Technologies' (Carlsbad, CA, USA) and configured to work with the company's 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, College of American Pathologists (CAP) and New York State guidelines. The online tool is also updateable for new guidelines and tests as they are developed.

Kimberlee Caple, head of Molecular Medicine Products at Life Technologies said, "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." She added, "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."

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