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Case Study – Evaluation Of Precision Of Quantitative Measurement Procedures: Support For CE IVD Marking For An Immunoassay Instrument

The concept of analytical performance includes different parameters that must be considered in the context of ensuring the quality, safety, and efficacy of an IVD device before placing it on the market. One of these parameters is precision (repeatability and reproducibility) which is summarized as the agreement between different independent measurement results of a sample in a series of measurements or between different series of measurements. Our customer sought our expertise to meet predetermined accuracy requirements on 26 parameters in the areas of bacterial infectious diseases, prenatal screening, oncology, and endocrinology to obtain CE marking for this instrument.

Discover the whole story in the case study below

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Poster – Novel Image Analysis And IHC Advances For NASH

Global prevalence of non-alcoholic fatty liver disease (NAFLD) is 25.24% in 2016, a percentage that has rapidly increased over the past decade.

There exist two types of NAFLD, non-alcoholic fatty liver (NAFL) and non-alcoholic steatohepatitis (NASH). Both Masson’s Trichrome Analysis CD45/ CD138/ Adipophilin IHC subtypes are associated with lipid accumulation in the liver, the latter being more severe with inflammatory cell infiltration, fibrosis and subsequent hepatocyte damage and impaired organ function.

The current gold standard for NAFLD diagnosis is liver biopsies evaluated by experienced pathologists who assign scores for several features (fibrosis, steatosis, inflammation and ballooning). However, documented inter-pathologist variability in scoring and semi-quantitative nature of the scoring system itself highlight the need for new methods to ensure the unbiased and consistent assessment of disease.

Our colleague Maroua Tliba has presented a poster on this during EASL 2023. Discover everything here by downloading the poster.

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Webinar – Cytek Aurora Instrument Standardization For Patient Testing In Global Clinical Trials

Recently Cerba Research’s Regional Head of Flow Cytometry, Veronica Nash, PhD, presented at CYTO 2023 and talks through Cerba’s work on Cytek Aurora instrument standardization for patient testing with the purpose of using them for global clinical trials.

Discover the full video here

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Poster – Workflow And Troubleshooting For Performance Qualification Of Cytek Aurora Instrument In A Clinical Setting

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.

Cerba Research US - Flow Cytometry Cytek Aurora

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Poster – Upscaling Of A Clinical Flow Cytometry Laboratory

As flow cytometry is one of the go-to methods for fast and in-depth monitoring of immune cell populations at single cell level, clinical laboratories are observing an increase in assay complexity and number of samples to process. To scale up our operations in a qualitative and efficient manner, several aspects of the laboratory design were improved and are discussed below.

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White Paper – Precision Medicine For Non-Small Cell Lung Cancer (NSCLC) – Emerging Trends In Molecular Analysis

Of all types of cancer, lung cancer caused more deaths worldwide than any other type of cancer. It also causes more deaths than breast and colorectal cancers combined. Patients with the most common lung cancer, non-small cell lung cancer (NSCLC), have higher survival rates than patients with small-cell lung cancer (SCLC), but the outcomes for both remain bleak. According to the National Cancer Institute, the five-year survival rate for NSCLC between 2004 and 2010 was 20.7% compared to only 6.3% for SCLC.2

NSCLC patients also have more promising and more precise, treatment options today compared to even 10 years ago. Advances in biomarker and precision medicine have led to the development of immunotherapies and targeted novel treatments that have the potential to improve patient outcomes. In the United States, the FDA has approved dozens of biomarker-driven therapies for NSCLC, including ALK, EGFR, and ROS1 inhibitors. Meanwhile, more than 1,200 treatments are in development.

Discover the latest trends in precision medicine for NSCLC in this white paper

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E-book – CAR+T Drug Development The Critical Role Of Flow Cytometry

Being one of the leading technologies for cellular analysis, flow cytometry generates simultaneous high-throughput enumeration and individual cell characterization data. With the breakthrough of cellular immune therapies, such as CAR+ T, flow cytometry became a critical platform, not only for clinical laboratories, but also for drug developers and manufacturers.

Flow cytometry plays a crucial role in the production process of CAR+ T cells, where it is used for assessing transduction efficiency, purity, and characterization of the CAR+ T product before infusion. After manufacturing, when CAR+ T cells are infused into the patients, flow cytometry is used again in clinical laboratories to assess CAR+ T expansion, efficiency, and persistence and to monitor minimal residual disease (MRD).

In this e-book, Ans De Beuckelaer, Regional Head Flow Cytometry EU and Rowan Claeys, Clinical Biologist at Cerba Research, dive deeper into key elements of flow cytometry:

  • The importance of flow cytometry in Car+T clinical research and its uses
  • Key aspects in developing a CAR+ T trial
  • The added value of flow cytometryin multiple myeloma, Minimal Residual Disease (MRD) assessments and multiple Myeloma phenotype
  • Car+T-cell Therapy: patient treatment, targeted antigens and solutions for MRD assessments and multiple myeloma phenotype assessment.
Cerba Research - Ebook - CAR+T Drug Development The Critical Role of Flow Cytometry
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Presentation – Automatization Of Immunohistochemistry Data Analysis For Protocol Validation

This presentation was given by Marie Gerus-Durand, Principal Scientist & Validation Engineer at Cerba Research Montpellier at the JMP Discovery Summit Europe.

Cerba Research is a global company providing high-quality, specialized analytical and diagnostic solutions for clinical trials. Cerba Research Montpellier develops customized immunohistochemistry protocols to detect the expression of selected targets on patients’ tissue sections.

To be used in clinical trials, these protocols must meet the regulatory agencies’ criteria to ensure that the protocol will allow consistent results on precious patients’ samples. With the diversity of parameters evaluated and the types of evaluation possible in implementing these custom protocols, automating data analysis became a need.

Thanks to various JMP® tools, we have developed an automated analysis that saves time and homogenizes protocol performance reports by including statistical and graphical data in a Dashboard. This process, submitted as JMP Add-in, has been incorporated into our user workflows, thus facilitating our procedures.

Tour our IHC Centre of Excellence in 360°

Cerba Research takes you on a 360 degree tour of their IHC Centre of Excellence lab

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Case Study – A Blood-based Biomarker Panel For Non-invasive Diagnosis Of Non-alcoholic Steatohepatitis: A Multi-centre Prospective And Validation Study

A late-stage biopharmaceutical company dedicated to metabolic and chronic liver diseases is developing an in vitro diagnostic (IVD) test for NASH at-risk patients. The test integrates four independent biomarkers – miR-34a-5p, A2M, YKL-40, and HbA1c. The output is a 0-10 score with threshold values, identifying patients with low risk or high risk of developing NASH.

The main objective of this study is to evaluate the physiological stability of these biomarkers between the fed and fasting state in patients with the target condition (NAFLD) over a 30-day period.

Discover how our team of experts helped this biopharmaceutical company to reach its goals

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Webinar – The Added Value Of Flow Cytometry In CAR T-Cell Clinical Trials Webinar

Watch Cerba Research’s latest webinar, ‘The Added Value of Flow Cytometry in CAR T-Cell Clinical Trials’.

The Added Value of Flow Cytometry in CAR T Cell Clinical Trials