Educational Resources for Laboratories Implementing Molecular Diagnostic Tests

How do labs implement molecular tests to meet complex clinical needs?

Laboratory developed tests (LDTs) and In Vitro Diagnostics (IVDs) are both in vitro diagnostic tests using body fluids (such as blood or urine) or cells/tissues (e.g., pap smear, biopsy) to detect or quantify levels of a desired biomarker. As LDTs and IVDs are both used to diagnose health conditions, it is crucial to understand the differences and advantages.

Differences between IVD tests and LDTs

In vitro diagnostic test	Laboratory developed test
Developed for sale to diagnostic laboratories, health clinics, or consumers Standardized instrument qualification procedures and training required Must be pre-validated with a data analysis and bioinformatics report Must be clinically validated	Developed by individual laboratories; not transferred, licensed, or sold Instrument qualification and training requirements established by individual laboratories Often developed in-house by necessity—no standard assay available Must be clinically verified and can be implemented quickly for emergency use*

*Must comply with the Clinical Laboratory Improvement Amendments (CLIA) of the U.S. Centers for Medicare and Medicaid Services.

Advantages of IVD and laboratory-developed testing in the lab

Quality system—Tests subject to number of requirements (design controls, manufacturing controls, and handling complaints)
Clinical validity—Helps ensure test detects or measures specified target analyte, or that it is useful for determining presence/absence of clinical condition or predisposition, prior to marketing
Technical support from supplier—To troubleshoot and replace faulty products
Broad distribution—Many laboratories utilizing the test provide data that can increase (or possibly decrease) confidence in the test. Laboratories performing the same IVD test can report proficiency results to confirm the accuracy of the test.
Simplified inventory control—Only order manufactured tests for anticipated use, which reduces the amount of documentation required. Requires less time and effort to maintain in-house IVD inventories.

Rapid adaptation—LDTs can be developed and modified relatively quickly to respond to market needs
Control over content—Laboratories can select specific and relevant targets
Lower cost per test—Technological advances and the availability of off-the-shelf bulk reagents have made complex analyses faster and more affordable
Laboratory qualification—The laboratory quality management system (QMS) covers all tests, including LDTs, which is not the case for IVD kit production
Consolidation into a single test—Testing for multiple analytes provides more data per sample and may enable faster diagnosis

Help keep your lab current and innovative with molecular testing

Skillful technicians work with samples, pipettes, and test tubes in the lab

Demystify molecular test development and implementation

As COVID-19 testing needs wane, laboratories need to consider what they can offer next.

Read blog › | 5 min read

7 spell-binding questions about laboratory developed tests

In this webinar, Professor Mara Aspinall brings a fresh perspective on the reasons to develop an LDT or purchase an IVD. She lays out a clear path for LDT implementation.

Watch webinar › | 52 min view

An introduction to diagnostic testing in laboratories

In this paper, we describe different diagnostic assays and explain why they are important for clinical laboratories. Learn about the advantages of IVDs and LDTs, and read about real-world examples.

Read now › | 21 min read

Test implementation in action

See what others are saying about molecular testing.

Challenges of establishing laboratory developed tests

Dr. Vijay Singh dispels common misconceptions about laboratory developed tests and shares his strategy for implementing LDTs in the lab.

Read blog › | 4 min read

Watch webinar › | 38 min view

Are you ready to take the next step to implement a molecular test in your lab?

If you’re new to molecular test implementation, then we recommend you start with Introduction to Diagnostic Testing in Clinical Labs.

7 things to know before establishing an LDT

How are LDTs implemented? Seven questions must be answered at each stage of the process. Read the 7 steps here.

Read blog › | 4 min read

LDT and IVD reimbursement in the U.S. explained

Having a basic understanding of coverage and reimbursement concepts will help you make informed and confident decisions when planning your strategy.

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How does the FDA distinguish between IVDs and LDTs? And other essential questions answered.

Navigating regulatory guidance for clinical laboratories

FDA regulation of IVDs and LDTs has fueled an ongoing, two-decade debate. IVD tests manufactured for use in multiple laboratories, including clinical assays...

Read blog › | 4 min read