Cytognos designed, in cooperation with the EuroFlow™ group, Next Generation Flow™ monitoring solutions for Hemato-oncology: MRD panels. NGF immunophenotyping protocols for hemato-oncology include 8-color tubes, allowing precise characterization of normal, reactive and neoplastic leukocyte populations. In addition, the combination of multiple antibodies in the same fluorochrome position allows the analysis of a larger number of antibodies in a single tube. The MRD panels are of a high quality. Cytognos, S.L. complies with ISO 9001:2015 Quality Management and ISO 13485:2016 for In Vitro products and research (BCP-ALL and MM MRD panel). Cytognos S.L. products for In Vitro Diagnostic comply with Directive 98/79/EC (MM MRD panel).
Cytognos offers two types of MRD panels:
- B-Cell Precursor Acute Lymphoblastic Leukemia MRD panel (BCP-ALL MRD)
- Multiple Myeloma MRD panel (MM-MRD)
B-Cell Precursor Acute Lymphoblastic Leukemia MRD panel (BCP-ALL MRD)
Flow cytometry has an essential role in the diagnosis and classification of acute leukemias together with cytomorphology and cytochemistry, by the detection and lineage assignment of blast cells in suspected samples.
The EuroFlow™ group has designed and evaluated a set of 8-color antibody panels for the diagnosis, classification and follow-up of acute leukemias, which can be used in combination with novel Infinicyt™ tools to optimize flow cytometric multidimensional immunophenotypic characterization of blast cells. The MRD panels were designed to answer specific questions that arise at different moments of the workflow and accordingly a 8-color panel was developed to help on the identification and quantification of residual pathological B cells in BCP-ALL minimal residual disease evaluation.
The BCP-ALL MRD panel designed by EuroFlow™ comprises a fully-standardized 8–color antibody panel and laboratory procedures with the intent of reaching a sensitivity of 10-6, comparable to real-time quantitative polymerase chain reaction (RQ-PCR)–based MRD detection. The BCP-ALL MRD panel is patented.
Multiple Myeloma MRD panel (MM-MRD)
Plasma cell disorders are a heterogeneous group of clinical disorders characterized by the expansion of clonal plasma cells in the bone marrow. The range of plasma cells disorders goes from Monoclonal Gammopathy of Undetermined Significance (MGUS) to symptomatic diseases such as Multiple Myeloma (MM).
Flow cytometry has proved to be an important tool in the diagnosis and classification of MM and other plasma cell disorders throughout the years. It has been demonstrated that abnormal plasma cells often show different phenotypes compared to their normal counterparts, namely the aberrant expression of CD56 in most patients or decreased levels of other molecules such as CD38, CD27, CD45 and CD138. These findings, together with other phenotypical changes, provide an aberrant plasma cell signature that allows for a specific and sensitive detection of the abnormal cells, crucial for an early diagnosis and a reliable follow-up.
EuroFlow™ has designed and validated a flow cytometry based method for MRD evaluation in MM. The developed panel is composed of two separate antibody combinations orientated towards the identification of immunophenotypically aberrant clonal plasma cells in bone marrow (BM) samples. The use of two tubes is an important quality control of the process since the test is performed in two replicates of the sample and also to confirm the clonality of suspected cells. An increased sensitivity due to the high number of cells analyzed is achieved. A sensitivity of as least of 10-5 has shown to be clinically meaningfull. The MM-MRD panel is patented.
View below video to understand the method for Minimal Residual Disease (MRD) evaluation in Multiple Myeloma (MM).
Optimal results can only be obtained by following the Euroflow™ SOPs in a 3-laser instrument (e.g. Omnicyt™) and performing data analysis using standardized templates and reference Databases included in the Infinicyt™ Software. Please contact Sanbio for more information about the MRD panels, we are looking forward to help you.
Click here for the 2021 catalog from Cytognos.