National Cancer Institute Biospecimen Evidence-Based Practices: Harmonizing Procedures for Nucleic Acid Extraction from Formalin-Fixed, Paraffin-Embedded Tissue

Sarah R. Greytak, Kelly B. Engel, Erik Zmuda, Esmeralda Casas-Silva, Ping Guan, Katherine A. Hoadley,
Andrew J. Mungall, David A. Wheeler, Harsha V. Doddapaneni and Helen M. Moore.

Biopreservation and Biobanking. Volume 16, Number 4, 2018. June 2018; doi: 10.1089/bio.2018.0046. [Epub ahead of print]


Variable and suboptimal biospecimen handling practices have been identified as impediments to biomarker discovery,1,2 including predictive biomarkers for oncology, indicating a clear and present need for evidence-based, standardized practices.To facilitate the implementation of evidence-based practices in biospecimen handling, BBRB has developed a document series termed Biospecimen Evidence-Based Practices (BEBP), which contains step-by-step procedural guidelines derived from peer-reviewed primary research articles and expert experience.4 The aim of the BEBP series is to promote a practical level of standardization and improve overall biospecimen quality and data reproducibility by specifying both optimal methods and suitable alternatives, while merging published evidence with practical knowledge of experts in the field. The intent of the BEBP is not to serve as a SOP, but to facilitate the development of evidence-based SOPs by individual laboratories. The present BEBP focuses on nucleic acid extraction from formalin-fixed, paraffin-embedded (FFPE) tissue biospecimens (see Supplementary Data; Supplementary Data are available online at Such biospecimens are being increasingly utilized in genomic research, and it has become clear over the past decade that variable and suboptimal FFPE biospecimen collection and processing practices can alter the quantity and/or quality of extracted DNA and RNA.


The authors thank Dr. Fay Betsou (IBBL, Luxembourg), Dr. Jakob Hedegaard (MOMA, Denmark), Dr. William Mathieson (IBBL, Luxembourg), and Dr. Geraldine Thomas (Imperial College, England) for their participation on the expert panel and their insightful recommendations. This work was funded by the National Cancer Institute’s Biorepositories and Biospecimen Research Branch.