Flow Cytometry Services
Development and Implementation of Flow Cytometry Assays for Use In Clinical Trials
Webinar Recorded:
May 21st, 2020
Comprehensive and Customizable Offerings
- Global capabilities
- Global, with all sites CAP accredited
- Harmonized instrument calibration and specific reagent qualification for consistent assay performance globally
- Robust and controlled assay transfers with data reproducibility at all global testing locations
- Custom assay development and validation
- Collaborative and consultative approach
- Dedicated pathology review (if required)
- Harmonized SOPs
16 Color Flow
3 days TAT*
*If no pathology review required
Assays Validated for the Intended Use
- Primary/secondary endpoint & safety with full pathology review (LDT)
- Exploratory (fit for purpose)
Flow Assay Design
Flow Assay Optimization, Validation, & Transfer
- Assay design/optimization (1-3 weeks)
- Antibody/clone/fluorochrome
- Sample type: whole blood, bone marrow aspirate, apheresis, PBMC/BMMC, etc. - Assay validation (4-6 weeks)
- Customize assay design & data reporting
- Client consultation and interaction
- Access to de-identified patient material/malignancies for validation purposes
- LDT validation / fit for purpose validation - Assay transfer to Rolle, if needed (2-4 weeks)
- Customize assay design & data reporting
- Client consultation
Example Assays and Reports:
CLL MRD
- 0.01% sensitivity
- 300K-1 million events
- Single tube Duraclone assay (8 color)
| Fluorochrome | FITC | PE | PC 5.5 | PE-Cy7 | APC | APC 750 | PB | KO |
| CLL MRD | CD81 | ROR1 | CD79B | CD19 | CD5 | CD53 | CD20 | CD45 |
B-ALL MRD
- 0.01% sensitivity
- 300K-1 million events
- 3-tube assay
| Fluorochrome | FITC | PE | PC 5.5 | PE-Cy7 | APC | APC 750 |
| B-ALL Tube 1 | CD20 | CD10 | CD38 | CD19 | CD58 | CD45 |
| B-ALL Tube 2 | CD9 | CD13/CD33 | CD34 | CD19 | CD10 | CD45 |
| B-ALL Tube 3 | Syto 16 | - | CD3 | CD19 | CD71 | CD45 |
MM MRD
- 0.001% sensitivity
- 3-5 million events collected
- Single tube assay (10 color)
| Fluorochrome | FITC | PE | PC 5.5 | PE-Cy7 | BV 421 | BV510 | APC | APC- A700 | PB | APC-H7 |
| MM MRD | cKappa | cLambda | CD117 | CD19 | CD81 | CD38 | CD27 | CD138 | CD56 | CD45 |
Example: Custom assay designed for immunophenotyping of T-cells, B-cells and monocytes
| Cell Type | Gating Strategy |
| Leukocytes | CD45+ |
| T cells | CD45+CD3+ |
| CD4+ | CD45+CD3+CD4+ |
| CD8+ | CD45+CD3+CD8+ |
| Naive T-cells | CD45+CD3+CD45RA+ |
| Memory T-cells | CD45+CD3+CD45RO+ |
| Transitional T-cells | CD45+CD3+CD45RA+CD45RO+ |
| B-cells | CD45+CD19+ |
| Monocytes | CD45+CD14+ |
Custom flow cytometry assays can be developed in house or transferred from client and/or partner laboratory.