PD-L1 assay comparability study published

Staburo supported the evaluation of the first multicentric analytical comparability study of PD-L1 expression in urothelial bladder cancer using four clinically developed immunohistochemistry assays. Statistical analyses included the investigation of inter-assay differences using ANOVA and intra-class correlations and the concordance for clinically relevant cut-offs based on Fleiss‘ kappa.

The results suggest that all four currently clinically relevant assays are analytically similar for the evaluation of PD-L1-stained immune cells and three (SP263, 22C3, and 28-8) for PD-L1-stained tumor cells.

The paper, which was recently published in Virchows Archiv, can be downloaded here (Staburo’s Statistics contribution is mentioned in the Acknowledgments): https://rd.springer.com/article/10.1007%2Fs00428-019-02610-z

R Shiny App for Standardized Detection of Outliers in Bioassay Development

The availability of reliable and sensitive assays is an important building block in the production and quality control of biological products. In the development of such assays, unusual or erroneous measurement results need to be detected, but adjudication by human operators is often inconsistent or prone to bias.

To help overcome this challenge, a Shiny app for the statistical detection of such outliers is being developed at Staburo: the Optimal Tool for Tracking of Outliers (OTTO). Close collaboration with the end users throughout the development process ensures that the statistical outlier detection results are in good agreement with subject matter expert evaluations. In particular, a mixed method approach was chosen which significantly reduced false outlier detection rates, compared to conventional statistical methods.

Thanks to the capabilities of the R Shiny technology, the user interface is intuitive and well suited for everyday use in the lab. Features of the app include application of outlier tests, automatic curve refitting after removal of outliers, and report generation for documentation purposes.

New employee @ Staburo

We are very happy to welcome Dr. Yesilda Balavarca in our team. Yesilda joins Staburo with her work experience from Deutsches Krebsforschungszentrum (DKFZ) Heidelberg and her excellent education background from University of Hasselt and University of Göttingen. She supports our clients in the areas of biostatistics and statistical programming as a Senior Biostatistician. We are looking forward to a great collaboration!