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Discipline

Methodology

Example biomarkers / assays

• Enzymatic analysis
• Colorimetry
• Turbidimetry
• Spectrophotometry
• Automated cell counting
• Conductivity and light scatter
• Chromatography

• 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

• 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

• 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

• Manual or automated ELISA
• Multiplex ELISA (bead-based detection, biochips), including ultra low-volume, low-level detection

• 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)

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

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

• Next-generation sequencing (from blood, bone marrow, FFPE, or frozen tissue)
• Bioinformatics and pipeline development
• Genotyping
• Microarrays
• CLIA NGS panels

• Digital PCR and high multiplex gene expression (e.g. Nanostring)
• RNA sequencing
• Targeted exome sequencing
• DNA methylation analysis
  miRNA sequencing
• Targeted gene sequencing (e.g., AmpliSeq Cancer Panel 2.0)
• Comprehensive Cancer Panel