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.

For the detection and monitoring of CAR T cells in patients, two main techniques are employed: PCR and flow cytometry. Flow cytometry, however, stands out for its ability to determine the phenotype of CAR T cells. This feature of flow cytometry is vital for assessing the expansion and persistence of CAR T cells in patients, aligning with the FDA’s draft guidance recommendations. The role of flow cytometry extends beyond detection to playing a pivotal role in monitoring CAR T cells during clinical trials. It enables investigators to gain deeper insights into the behavior of CAR T cells post-infusion and their interaction with the patient’s endogenous immune system. Understanding these dynamics is crucial for evaluating the efficacy and safety of CAR T cell therapies.

In summary, flow cytometry is not just a tool for detection; it is a critical component in the advancement and monitoring of CAR T cell therapies, offering invaluable insights into the therapeutic potential and interaction of these engineered cells within the patient’s immune system.

In this poster, first presented at ESCCA 2023, discover how Cerba Research has implemented both autologous and allogenic CAR T assays.

Addressing a significant gap in the market, this collaboration aimed to overcome the limitations posed by the scarcity of Ki-67 expressing cells in standard biological samples. The synergy between Cerba Research’s expertise in clinical trial services and Slingshot Biosciences’ cutting-edge technology led to the creation of a custom-made Ki-67 cell mimic.

This solution not only met but exceeded the expectations in assay validation, showcasing a leap forward in flow cytometry techniques. This case study highlights the transformative impact of this project, marking a milestone in assay validation and flow cytometry applications in clinical research.

The ability of developing high-parameter assays allows for a deeper characterization of patients’ immune subsets with limited sample availability. Spectral flow cytometry is used to assess high-parameter immune profiling in global clinical trials. To date, there are no specific guidelines for Performance Qualification (PQ) of spectral flow cytometers. Here, we describe an in-house developed workflow for performing PQ of a Cytek® Aurora instrument in a clinical laboratory.