Laboratory Developed Tests: Issues and Anticipated Regulations

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On July 31, 2014 the FDA notified Congress of the Agency’s intent to issue a draft oversight framework for Laboratory Developed Tests (LDTs) based on risk on patients.

This is a change from the current framework where regulatory oversight is determined based on whether the LDT is made by a conventional manufacturer or a single laboratory. FDA released the draft guidances describing the regulatory oversight for LDTs, which uses a risk-based approach and will be implemented over the course of multiple years.

The agency intends to enforce device registration and listing with the FDA for most LDTs. In addition, the agency will require the LDT manufacturers to submit adverse event reports to enable better post-market surveillance monitoring. For high and moderate-risk LDTs, the FDA intends to have pre-market review and will enforce the quality system regulation, which affects design controls and the manufacturing of LDTs.

Under the draft framework, the FDA will continue to exercise enforcement discretion for low-risk LDTs and LDTs for rare diseases and unmet needs. Laboratories and hospital systems that rely on the use of LDTs in their clinical practice should be familiarized with the FDAs proposed LDT regulations. The anticipated regulations are an overhaul of the current landscape, but will mostly promote safe and effective use of all in vitro diagnostic devices.

What is a Laboratory Developed Test?

An LDT is an in vitro diagnostic product (IVD) that is designed, manufactured, and used within a single laboratory. To create the LDT, laboratories use reagents and analyte specific reagents combined with general laboratory instruments to develop test protocols, which are then verified and validated to provide a clinical diagnostic result.

 

LDTs were originally very different from IVDs; they were initially used to diagnose rare diseases or used for local patient populations. LDTs should only be manufactured using components that are legally marketed for clinical use, but that is not always the case in all laboratories.

Additionally, LDTs should be completely designed and manufactured in the laboratory that is using the test system; however, this has not been the case due to the influx of technology and the complexity of hospitals and laboratory networks. The advancements in technology and software have enabled the creation of new tests using algorithms and complex procedures, but this development brings added risks and concerns from FDA.

FDA understands that LDTs are important to the development of personalized medicine, but has to balance this with the need to ensure that diagnostics are accurate for the protection of patients and health care providers.

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Topics: Process