New and effective therapies, targeting antibodies and blocking molecules, are being developed to further improve treatment outcome while increasing quality of life.
For this particular setting, MRD assessment emerges as a tool to evaluate patient’s response to treatment since it measures tumor burden and can be used as an efficacy-response and prognosis biomarker.
Cytognos-EuroFlow™ NGF methodology complies with all considerations of clinical trials for cell-based assays as defined by FDA and EMA (2018 Draft):
- The number of events to be collected is pre-specified in each assay to reach the required sensitivity.
- Consistent panels of antibodies and fluorochromes are defined for each application.
- Sample collection, stability and time for processing are pre-established to reduce variation in results.
- Analysis templates and reference databases ensure reproducibility of analysis between sites and operators.
- Specific antibody expression alterations caused by therapy are overcome by using antibodies with multi-epitope-specificity in the evaluation panels.
- Potential regeneration of bone marrow samples is assessed since complete immunophenotype of the sample is evaluated.
- Hemodilution is taken into account when reporting results to assure reliable reporting.
“Standardized and validated methodologies such as NGF can ensure that results obtained in different laboratories are consistent improving the accuracy, precision, specificity and sensitivity in all evaluation sites.”
Cytognos Technical Support team have the required experience, know-how and training resources to achieve successful implementation of the NGF methodology independently of the site (public and private hospitals, research facilities or other). The following points are addressed during technical support:
- SOPs for cytometer set-up: Instrument standardization introduced in all labs.
- SOPs and stable lyophilized kits for sample processing: Inter and intra laboratory reproducibility.
- Data analysis: Reference databases with standardized reports bring a common language to the different sites.
Technical support is available here, webinars or onsite visits. Cytognos provides a variety of solutions and products specifically aimed at the establishment of monitoring techniques for clinical trials. Feel free to contact us to know more about them.
- U.S. Food and Drug Administration. 2020. Hematologic Malignancies: Regulatory Considerations. [online] Available at: <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/hematologic-malignancies-regulatory-considerations-use-minimal-residual-disease-development-drug-and> [Accessed 13 August 2020]. Go to publication
- Guideline on the use of minimal residual disease as a clinical endpoint in multiple myeloma studies – European Medicines Agency. European Medicines Agency. (2020). Retrieved 13 August 2020, from https://www.ema.europa.eu/en/guideline-use-minimal-residual-disease-clinical-endpoint-multiple-myeloma-studies. Go to publication