Demystifying the Development and Implementation of Molecular Tests in a Clinical Laboratory

Understanding Laboratory Developed Tests

Many laboratories around the world have adopted expanded diagnostic testing capabilities to address the coronavirus pandemic and are now seeking ways to expand testing with additional workflows for infectious disease syndromic panels, pharmacogenomic analysis, oncology testing, and more.

Historically, developing a molecular test within a clinical laboratory has been perceived as a complicated and laborious process. In this webinar, we aim to dispel common misconceptions of laboratory-developed tests by providing a comprehensive overview of what it takes for a clinical laboratory to bring an in-house molecular test to market.

Learning Objectives

This webinar will help you:

• Describe different types of laboratory developed tests
• Identify differences between laboratory developed tests and IVD tests
• List the benefits of running a laboratory developed test
• Explain how laboratory developed tests are designed and regulated in the U.S.

Watch on Demand       Download Slides (PDF, 1.4MB)

For research use only. Not for diagnostic procedures.

This webinar is produced by Whitehat Communications, a provider of continuing education programs in clinical laboratory sciences that has been approved by the ASCLS P.A.C.E.™ Program. One P.A.C.E. credit hour will be provided for this complimentary, basic-level program.

Mara G. Aspinall, Managing Director, Health Catalysts Group and Professor of Practice, Biomedical Diagnostics, Arizona State University

Mara Aspinall is a healthcare industry leader and pioneer committed to active civic involvement. She is managing director of the Health Catalysts Group, a consulting firm for healthcare information technology and diagnostics that publishes the popular Health Catalysts Diagnostics Year in Review. She is also managing director and co-founder of BlueStone Venture Partners. Aspinall is a member of the board of directors of Abcam plc, Allscripts, Castle Biosciences, OraSure, and Blue Cross Blue Shield of Arizona. In addition, she advises The Rockefeller Foundation on COVID-19 diagnostics and is co-author of the foundation’s national reports on COVID testing education and policy recommendations.