Although it is an important biomarker in oncology (mostly in breast and prostate), Ki-67 immunohistochemistry (IHC) analysis has yet to be standardized. Working groups have provided guidelines for Ki-67 scoring in different cancer types to limit pathologist’s variability.

Digital analysis solutions to assist scoring with image analysis or artificial intelligence (AI) have recently emerged in the evaluation of Ki-67 as rapid and robust solutions. In this context, we compared the results of Ki-67 scoring performed with Aiforia Platform ® (AI platform) and Halo ® (image analysis supervised software) against three independent pathologists on various solid tumors.

Discover more about this in the case study.

Explore the intersection of high-parameter spectral flow cytometry and global clinical trials through our meticulous process at Cerba Research, Ghent, Belgium, and Cytek Biosciences, California, USA. We delve into instrument standardization’s critical role for transparent results across labs and introduce innovative methods for implementing and standardizing Cytek® Aurora Instruments.

Witness our multi-step process, evaluating optical alignment, system resolution, laser and detector stability, and analytical validation. Our in-house workflow ensures precision, with deviations well within acceptance criteria. Discover the effectiveness of SpectraComp® beads for spectral unmixing, reducing errors and optimizing workflow.

Join us as we demonstrate instrument comparability and consistent performance, propelling forward the standardization of Cytek® Aurora Instruments for reliable insights in global clinical trials.

Explore our validated 14-color assay, a breakthrough in immune monitoring for hematological malignancies and cell & gene therapy trials. Using spectral flow cytometry, our method offers in-depth characterization of T cells, B cells, NK cells, and monocytes, crucial for global clinical trials.

The assay’s precision, demonstrated through repeatability, reproducibility, and inter-operator variability, ensures reliable data interpretation. Notably, viability dye titration and sample stability evaluations enhance the assay’s robustness.

Our commitment to advancing drug development is exemplified through this cutting-edge flow cytometry assay, providing a comprehensive and reliable tool for monitoring immune cells in peripheral whole blood across diverse clinical settings.

In our efforts to validate the efficacy of this software module in standardizing flow cytometry assays, we undertook a comprehensive evaluation. This involved assessing the Median Fluorescence Intensity (MFI) both between different instruments and within the same instrument over time. For this purpose, we utilized two distinct types of calibration particles: BD® Cytometer Setup and Tracking (CS&T) beads, provided by BD Biosciences, and SPHERO™ Ultra Rainbow calibration particles, from Spherotech.

The focus on maintaining consistent performance in flow cytometry, through the use of advanced software and calibration methods, is crucial in ensuring the reliability and accuracy of results obtained from these sophisticated instruments. This is especially significant in the context of global clinical trials, where standardization across different settings is key to obtaining universally applicable and credible data.