Safety testing hematology/coagulation, special chemistry/urinalysis |
- Enzymatic analysis
- Colorimetry
- Turbidimetry
- Spectrophotometry
- Automated cell counting
- Conductivity and light scatter
- Chromatography
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- Routine chemistry (including serum factors for TLS)
- Renal function (eGFR, creatinine, cystatin C)
- Hepatic function (ALT/AST, bilirubin)
- Urinalysis
- Endocrinology
- Thyroid function
- CBC with WBC differential
- Reticulocytes
- HbA1c
- Prothrombin time, aPTT, fibrinogen
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Anatomic and molecular pathology |
- Tissue processing (FFPE, TMAs)
- Confirmatory diagnosis
- Immunohistochemistry, including H-score, tumor proportion scores, and other assay-specific scoring algorithms
- ISH/FISH/Dual ISH
- Molecular mutation assays
- Digital pathology: Slide scanning, image repository with sponsor portals, image analysis, diagnostic algorithm development
- Special histologic stains
- Companion and Complementary Diagnostics
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- Lung panel: ALK, EGFR, ROS1, MET
- Breast panel: ER, PR, HER2, HER3, pEGFR, pHER2, pHER3, PTEN, FOXP3
- Hematopathology panel: CD19-23, CD45, CD3-5, CD8, CD10, CD30, CD34, BCL2, BCL6, MUM1, Ki67, Kappa, Lambda, CD47, CD56, CD68, CD79, CD117, CD138
- PD-L1 markers: 22c3, 28-8, SP263, SP142
- ISH/FISH/Dual ISH assays: ALK, ROS1, HER2 (breast and gastric carcinoma, other tumor types), EGFR, PIK3CA, CLL panel, FGF19, FGFR1/EBER ISH, MET Dual ISH, HPV CISH
- Mutations: PIK3CA, EGFR, HGF, ROS1, KRAS, BRAF
- Assorted Markers (not comprehensive): Nectin, Claudin 18, MUC 17, FGFR2b, B7-H3, PAX-5, PAX-8, TROP2, LAG-3, STAT5, SOX10, AMACR, p16, p63
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Immunoassay |
- Manual or automated ELISA
- Multiplex ELISA (bead-based detection, biochips), including ultra low-volume, low-level detection
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- Immunogenicity assays
- Soluble tumor antigens (CA-125, CA-15-3, CA-19, CEA, HE4)
- Inflammatory and angiogenesis panels
- (e.g., IFNα TNF-α, IL1β IFNγ, VEGFs, Ang-2, etc.)
- Oncoproteins/ligands: HGF, FGFs, SCF, neuregulins, soluble receptors (VEGFR, FGFRs, sHER2)
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Flow cytometry |
Standardized next generation platforms - Harmonized, redundant instrumentation with standardized settings to ensure data consistency
- 3L (V-B-R) BD FACS Canto, transitioning to 3L (V-B-R) BD FACS Lyric
- 5L (UV-V-B-Y/G-R) Cytek Aurora
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Broad applicability across indication and therapeutic modality
Immunophenotyping
- Therapeutic target phenotyping and quantitation for biologics (mABS, BsAB, TsABS, ADC) or cell therapies
- Immune subset phenotyping based on predicted drug MOA
Target engagement
- RO assays for biologics (mABS, BsAB, TsABS, ADC)
- Protein phosphorylation/inhibition/degradation for small molecules or ADCs
Pharmacokinetics
- CAR-T/CAR-NK/CAR-MAC, TCR-T phenotyping and quantitation
Measurable/minimal residual disease
- MM, BCP-ALL, AML, CLL MRD Panels
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