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J Mol Diagn. 2021 Apr;23(4):399-406. doi: 10.1016/j.jmoldx.2021.01.006. Epub 2021 Jan 23.

Innovative Tumor Tissue Dissection Tool for Molecular Oncology Diagnostics.

The Journal of molecular diagnostics : JMD

Manana Javey, Christina Reinsch, Mirjam Feldkamp, Sandra Siemann, Anja Blüher, Corinna Woestmann, Lingling Cai, Ian Tran, Theresa May, Charles Havnar, Amy A Lo, Bernd Hinzmann, Gabrielle Heilek, John F Palma

Affiliations

  1. Roche Sequencing Solutions, Pleasanton, California. Electronic address: [email protected].
  2. Signature Diagnostics, Potsdam, Germany.
  3. Roche Sequencing Solutions, Pleasanton, California.
  4. Genentech Inc., South San Francisco, California.
  5. Roche Sequencing Solutions, Pleasanton, California. Electronic address: [email protected].

PMID: 33497835 DOI: 10.1016/j.jmoldx.2021.01.006

Abstract

Formalin-fixed, paraffin-embedded (FFPE) tissue is the most commonly used material for tumor molecular profiling, therapy selection, and prognostication. Tumor tissue enrichment by tissue dissection is highly recommended to generate quality data reproducibly for use in downstream assays, such as real-time PCR and next-generation sequencing. The aim of this study was to evaluate the performance of the automated tissue dissection tool AVENIO Millisect System compared with a manual dissection method using 18 FFPE tissue specimens. The study assessed performance of these two methods with paraffinized and deparaffinized sections at 5- and 10-μm thickness as well as at low (5% to 10%) and high (>50%) tumor content. In addition, compatibility with various nucleic acid and protein extraction methods was assessed. Overall, dissection by Millisect resulted in statistically significantly higher yields of nucleic acids and protein compared with manual dissection (P = 0.00524). In downstream analysis on a statistically nonpowered sample set, EGFR mutation testing by PCR led to highly concordant results, and next-generation sequencing testing yielded significantly higher allelic frequencies when tissue was dissected by Millisect compared with manual scraping, demonstrating noninferiority of the automated method. In summary, the AVENIO Millisect System may replace manual labor and support automation of FFPE tumor tissue workflows in clinical molecular laboratories with high testing volumes with adequate validation.

Copyright © 2021 Association for Molecular Pathology and American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.

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