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Cancer 'moonshot' won't take off without authenticated cells.

Irreproducible research and efforts to combat this complex, global and multi-billion dollar problem were top stories in several 2015 retrospectives, including Science News and Nature. And with President Obama's State of the Union announcement of the cancer "moonshot," the importance of research reproducibility will now be put under an even higher resolution microscope. Although preclinical irreproducibility can arise in multiple areas of the research and publication process, I would like to focus on issues specific to immortalized cell lines, which have been workhorses in the lab for decades. Accurate documentation of tissue of origin and species are critical to ensure the quality, reproducibility and translation of data generated from cell-based studies. Yet a far too common and ultimately avoidable cause of irreproducible biomedical research is the widespread use of misidentified (including intraspecies and interspecies cross-contamination) or mislabeled cell lines. Estimates vary, but the most frequently cited range is that from 18 to 36% of cancer cell lines are cross-contaminated or mislabeled.

Correct identification of the origin of a cell line--authentication--can be determined by comparing the genetic signature (DNA profiling or fingerprinting) with established databases to confirm identity. Biologists should be aware of both the problem and the solution--an accredited standard for authentication based on short-tandem repeat (STR) profiling. Surprisingly, however, there is little evidence that authentication is routinely performed in the lab--particularly among academic researchers. Many scientists remain unaware or unconvinced of the need to obtain, establish and carefully maintain cell cultures, and do not authenticate their cell lines often enough or at all. A survey of almost 450 life science researchers recently conducted by the Global Biological Standards Institute (www.gbsi.org/publication/ cell-culture-survey), found that the majority (52%) of respondents never perform authentication or other species-related QC tests on cell lines used in their experiments. Moreover, 74% never use the accepted standard--STR profiling--a percentage that varied little between academia, industry, government and non-profit researchers. The top three reported barriers to performing cell line authentication were cost (61%), time (53%) and delays in research (35%).

So, despite the availability of practical, cheap (as little as $100 per sample) and effective cell authentication tests, new reports of misidentified or contaminated cell lines still appear in the scientific literature with alarming frequency. Clearly, the "de facto honor system" that assumes other researchers have used proper cell culture practices and authenticated their cell lines together with a "not in my lab" presumption is not working. This dysfunctional culture persists despite multiple calls for, and limited adoption of, expanded use of authentication in recent years. For example, an increasing number of journals encourage but do not require authentication as a condition for manuscript submission or publication. While recent NIH initiatives to improve the reproducibility of funded research have recognized the importance of establishing best practice guidelines and validating key biological resources such as cell lines, they do not yet require authentication as a condition for funding. What more can and should be done?

We believe that fixing the problem will demand a systematic, incremental approach with commitment by all stakeholders--from researchers to funders to publishers--that embraces the importance of targeted training and education. To that end, GBSI is leading a multi-partner Cell Authentication Alliance of committed stakeholders as well as an advocacy campaign to build awareness among life science researchers regarding the importance of cell authentication and to actively change the current culture of laboratory practices and policies. With funding support from NIH and Susan G. Komen, we are also developing a freely available and exportable "active learning" training module that will feature highly interactive training units and include how to videos.

As a result of targeted training, effective policies, and the use of standards and best practices in cell-based biomedical research, a cascade of positive results can be expected, including: knowledge of why and how to perform cell authentication will improve; cell line misidentification will decrease; data reproducibility will increase; scarce research dollars will be used more efficiently; and ultimately and most importantly--translation time from bench to clinic to bedside will diminish. In order for the President's Cancer Moonshot initiative and other ambitious efforts to succeed, the work needs to start in the trenches, or in this case, under the tissue culture hood.

Editor's Note: We invite you to submit your personal commentaries to Last Word on topics that impact your work and affect the overall industry. Share your thoughts and opinions on issues within the profession that need to be addressed. Please send your commentaries and suggested topics to Michelle Taylor, Editor-in-Chief, at michelle.taylor@advantagemedia.com.

Leonard Freedman

President

Global Biological Standards Institute (GBSI)

www.gbsi.org
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Title Annotation:Last Word
Author:Freedman, Leonard
Publication:Laboratory Equipment
Date:Feb 1, 2016
Words:767
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