Innovative Tumor Tissue Dissection Tool for Molecular Oncology Diagnostics

Area of Science:

• Oncology
• Molecular Pathology
• Laboratory Automation

Background:

• Formalin-fixed, paraffin-embedded (FFPE) tissues are crucial for tumor molecular profiling.
• Accurate tissue dissection is essential for reliable downstream assay results.
• Manual dissection can be labor-intensive and variable.

Purpose of the Study:

• To evaluate the performance of the automated AVENIO Millisect System for tissue dissection.
• To compare the automated system against manual dissection methods.
• To assess compatibility with various extraction methods and downstream analyses.

Main Methods:

• Comparison of automated (AVENIO Millisect) and manual tissue dissection.
• Evaluation across different FFPE section thicknesses (5- and 10-μm).
• Assessment at varying tumor content levels (5-10% and >50%).
• Analysis of nucleic acid and protein yields.
• Downstream analysis including EGFR mutation testing (PCR) and next-generation sequencing (NGS).

Main Results:

• The Millisect System yielded statistically significantly higher amounts of nucleic acids and protein compared to manual dissection (P=0.00524).
• Downstream EGFR mutation testing by PCR showed highly concordant results between methods.
• NGS analysis revealed significantly higher allelic frequencies with Millisect-dissected tissue, demonstrating noninferiority.

Conclusions:

• The AVENIO Millisect System offers a viable, automated alternative to manual labor for FFPE tumor tissue dissection.
• This system can support the automation of clinical molecular laboratory workflows, especially for high-volume testing.
• Validated use of the Millisect System can improve reproducibility and data quality in molecular diagnostics.