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LabRoots, Inc.


October 2019

Webinar: Ditch the Excel spreadsheets and manage your molecular workflows entirely in your LIMS

October 2 @ 2:00 pm - 3:00 pm EDT

"Ditch the Excel spreadsheets and manage your molecular workflows entirely in your LIMS. Achieve configuration of molecular workflows, with an integrated solution for inventory control of test reagents and QCs, as well as biorepository management for your samples and plates processed through your workflows, maintaining the genealogy of your samples. Join us in this session to learn more about the Workflow Engine solution that can support managing complex molecular workflows such as NGS."

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Webinar: Analytical and Clinical Validation Requirements for Next Generation Sequencing Laboratory-Developed Tests

October 17 @ 1:00 pm - 2:00 pm EDT

"Next generation sequencing (NGS) has revolutionized molecular diagnostic testing. It is important to note that, as with many molecular diagnostic tests currently in clinical use, there are very few FDA-approved or FDA-cleared NGS assays, and thus analytical and clinical assay validation of laboratory-developed tests (LDTs) is essential to the application of NGS technology for clinical diagnostic testing. Both analytical and clinical performance parameters must be established for NGS-based LDTs. Analytical performance parameters include accuracy, precision, reportable range, and reference interval, as well as analytical sensitivity, analytical specificity, and any other parameter that is considered important to assure the analytical performance of a particular test (e.g., specimen stability, carryover). The clinical validity and clinical utility of the testing must also be considered. The College of American Pathologists (CAPs) Molecular Pathology Checklist requirements, universally recognized as providing best-in-class standards for clinical laboratory testing, address the analytical and clinical validation of NGS-based LDTs."

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