DNA microarrays in the clinic: how soon, how extensively?

Area of Science:

• Molecular Biology
• Genomics
• Clinical Diagnostics

Background:

• DNA microarrays are prevalent in research but underutilized in clinical settings.
• Clinical tests have stringent requirements differing from research tools, demanding proven utility.
• A distinction exists between genomic diagnostics (mutation detection) and expression profiling (prognosis/prediction).

Purpose of the Study:

• To analyze the reasons for slow clinical adoption of DNA microarrays.
• To differentiate between established genomic array diagnostics and those requiring further clinical validation.
• To project the future role of DNA arrays in clinical diagnostics.

Main Methods:

• Review of current DNA microarray applications in research versus clinical practice.
• Analysis of the distinct requirements for clinical diagnostic tests versus research tools.
• Categorization of DNA array tests into genomic and expression profiling types.

Main Results:

• Genomic array diagnostics, focused on mutations, deletions, or duplications, have established clinical evidence.
• Expression profiling tests for prognosis or prediction require rigorous proof of clinical correlation.
• Currently, most clinical array diagnostics are of the genomic type.

Conclusions:

• Clinical utility and distinct testing requirements hinder widespread DNA microarray adoption.
• Genomic array diagnostics are currently favored in clinical practice due to established evidence.
• Advancements in technology and increased parameter measurement will likely expand the diagnostic role of DNA arrays.