Diagnostics Reform and Harmonization of Clinical Laboratory Testing

Area of Science:

• Clinical diagnostics
• Regulatory science
• Laboratory medicine

Background:

• The United States is experiencing rapid developments in diagnostics reform legislation.
• Stakeholders including patients, practitioners, laboratories, manufacturers, and regulators are actively debating the future regulatory framework for clinical laboratory testing.
• Standardization of clinical laboratory tests is a central issue in these reform discussions.

Purpose of the Study:

• To highlight the importance of clinical laboratory test standardization within the context of ongoing diagnostics reform.
• To compare the nature and regulation of laboratory-developed tests (LDTs) and in vitro diagnostic (IVD) kits.
• To review evidence supporting the standardization of LDTs and their concordance with IVD kits.

Main Methods:

• Review of current legislative and regulatory landscapes for diagnostics in the US.
• Definition and comparison of laboratory-developed tests and in vitro diagnostic kits.
• Analysis of published interlaboratory comparisons for LDTs and comparisons between LDTs and IVD kits.
• Examination of ongoing standardization projects and regulatory agency feedback.

Main Results:

• Laboratory-developed tests are performed in specific labs by experts, while in vitro diagnostic kits are designed for broader use.
• Both LDTs (regulated by Clinical Laboratory Improvement Amendments) and IVD kits (regulated by the US Food and Drug Administration) are stringently controlled.
• Published studies show high reproducibility for LDTs and high concordance between LDTs and IVD kits.

Conclusions:

• Clinical laboratory test standardization is a vital component of diagnostics reform.
• Evidence suggests that LDTs are reproducible and comparable to IVD kits, supporting standardization initiatives.
• The US Food and Drug Administration recognizes the need for standardization and is seeking input on facilitating it.