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Explore the benefits and challenges of bringing an in-house molecular test to market, with real-world examples

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 series, we aim to dispel common misconceptions of laboratory developed tests (LDTs) by inviting industry experts to share about the advantages, design and implementation process, and establishment of LDTs in clinical laboratories. Learn about how the flexibility of in-house molecular-based tests can help a clinical laboratory impact patient outcome and remain competitive.

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The Simple, Sensible, Salient & Still Spell-Binding Seven Questions about Laboratory Developed Tests

Abstract

In this webinar, Mara G. Aspinall provides a comprehensive overview of the advantages and implementation process of in-vitro diagnostic tests like LDTs and IVDs and describes how these tests are regulated in the US.

Learning objectives:

Describe different types of in-vitro diagnostic tests
Identify differences between laboratory developed tests (LDT) and in-vitro diagnostic (IVD) tests
List the benefits of running LDTs and IVDs
Explain how laboratory developed tests are designed and regulated in the US

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

Challenges of Establishing Laboratory-Developed Tests

Abstract

In this webinar, Dr. Vijay Singh, Director of Molecular Diagnostics at HealthTrackRx, shares his experience of bringing an in-house molecular test to market. He discusses the advantages, challenges, and considerations he encounters when designing and implementing molecular tests at his laboratory.

Learning objectives:

Describe advantages of implementing a laboratory-developed test
List decision criteria for assay design and target selection
Recall analytical and clinical validation considerations

Dr. Vijay Singh
Director of Molecular Diagnostics, HealthTrackRx

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I am interested in the following molecular solution(s) (check all that apply):*

Respiratory pathogen detection

Urinary tract pathogen detection

Vaginal microbiota pathogen detection

COVID-19 testing

Pharmacogenomics

Oncology

I am interested in bringing new/additional molecular test(s) to my lab in the next 6–12 months:*

Yes