Who we are

Technical strategy for discovery/preclinical, translational research, companion & complementary diagnostics with focus on immunohistochemistry

Solutions

Developing immunohistochemistry companion or complementary diagnostics

Strong track record working within and with biopharma developing, optimizing, and validating immunohistochemistry (IHC) companion or complementary diagnostics (CDx) for immuno-oncology programs - PD1 Keytruda/Merck, PD1 Nivolumab/BMS, and Lag3 Relatlimab/BMS & Labcorp

Using multiplex quantitative immunohistochemistry for biopharma clinical trials

Leading efforts to bring multiplexed quantitative immunohistochemistry (mBF) and immunofluorescence (mIF) into biopharma clinical trials and as FDA-approved IVD tests, including development of spatial biology CDx utilizing antibody-mediated multiplexing and cell phenotyping

Managing contract research development services

Strategic and functional oversight of multi-disciplinary contract research development services in CAP/CLIA high throughput laboratories, providing global clinical trial support delivering AI-derived signatures and tailored analysis plans for translational pathology and immunotherapy projects

Companion Diagnostics

Development of a Prototype Immunohistochemistry Assay to Measure Programmed Death Ligand-1 Expression in Tumor Tissue

The basis for the companion diagnostic for pembrolizumab (Keytruda) - used in Merck-sponsored clinical trials to assess the utility of PD-L1 as a potential prognostic biomarker, predictive biomarker, or both. 

See project

Single Site PMA

Development of a LAG-3 immunohistochemistry assay for melanoma

Specificity, sensitivity, analytical precision and reproducibility of a monoplex immunohistochemistry assay used for RELATIVITY-047 (NCT03470922), a phase II/III clinical trial for relatlimab (BMS), to stratify patients based on the percentage of LAG-3 positive immune cells

See project

Multi-Site Study

Multi-institutional TSA-amplified Multiplexed Immunofluorescence Reproducibility Evaluation (MITRE) Study

Standardization and validation of an end-to-end workflow for multiplexed immunofluorescence (mIF) that supports multisite trials and clinical laboratory processes

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An six-plex mIF panel characterizing the PD-1/PD-L1 axis (PD-L1, PD-1, CD8, CD68, FoxP3, CK) using TSA-fluorescent detection reagents

Strategic Thinking

CDx requirements for spatial biology using multiplex immunofluorescence and multispectral imaging

The scientific, clinical, and economic requirements for developing clinical mIF. Attributes to support predictive tests, including design principles, verification, and validation needs. Regulatory, safety and quality considerations. Application as lab-developed-tests and regulated in vitro diagnostic devices

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Thematic Review

 New Technologies to Image Tumors

Advanced multiplex IHC technologies enabling target discovery in the tumor microenvironment (TME), and adopted for use in patient stratification and therapy guidance

See project

Multiparameter imaging using metal ion-tagged antibodies and mass spectrometer; three targets from a 21-plex panel, rare-earth ions quantitated & spatially reassigned creating a 2-D image similar to routine IHC

Understanding strategic focus of our partners 

Using immunohistochemistry to improve outcome for individual patients

  • Biopharma needs robust platforms to move quickly from discovery to diagnostics
  • There is a growing need to identify complex phenotypes or provide spatial relationships, particularly in immuno-oncology
  • Multiplex immunohistochemistry with spatial readouts can identify clinically relevant marker sets for early stage trials and facilitate better designs for the late stage

Perspectives offered

  • Guidance for monoplex and multiplex immunohistochemistry and immunofluorescence
  • Recommendations for value-add spatial biology technology to expedite decision making
  • Gap analysis, turning discovery-driven findings into standardized, reproducible and high throughput clinical assays
  • Drafting project plans, including milestones, risks or obstacles, for key programs using IHC
  • Connecting biopharma teams with contract research service organizations; vendor management and alignment of operating models
  • Design of technical studies and strategy with probability of success for diagnostics and commercialization
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