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Strong portfolio of immunotherapy related biomarkers

Our assay development team maintains vigilant surveillance of emerging biomarkers to assess immune infiltrates and the tumor microenvironment. In addition to the biomarkers mentioned in this proposal, we have additional biomarkers (both current and pipeline) that address the regulation, immunosuppression and activation dynamics that interplay between the immune infiltrates and the tumor microenvironment. Our extensive validation effort include full review of specificity, sensitivity and reproducibility parameters.

Large number of immunotherapy trials across multiple tumor types

Our team of pathologists and imaging scientists have assessed over 5000 PD-L1 IHC immunostains and almost an equal amount of quantitative CD8 measurements. We have reviewed solid tumors such as melanoma, lung, breast, bladder, renal cell carcinoma and colorectal cancer. We have developed a proprietary semi-quantitative  immune infiltrate assessment and also captured expression patterns across tumor types.

Experience with semi-quantitative and quantitative imaging

We have invested time and resources to develop a CAP-CLIA-GCP driven image analyses workflow that harnesses the best combination of robust and innovative technologies for scanning, analyses and viewing. Our system is designed not just to do its job well but to do it simply and reproducibly and to thrive in the multiple variables of multi site global clinical trials.

Note: We are implementing a novel technology that will allow us to capture staining across serial sections of single biomarkers and then use software to combine these results in a single picture. The user will able to view these biomarkers in any combination. Using this technology, C-LOTS (Co-LOcalization Technique with Serial Section), we can combine our existing validated assays in brightfield mode. This provides greater flexibility on top of our multiplex IF capabilities.

Experience with IVD assays and diagnostic companies

Our lab serves as the clinical site for medical device companies pursuing PMA approvals. Currently, we have approximately 20 such clinical trials with more on the way. Our process is honed for appropriate documentation integration, QA oversight and response to the tri-partite efforts of pharmaceutical companies, diagnostic manufacturers and regulatory bodies.

Self-Investment in immunotherapy research 

Using our revenue and grant awards, we fund our Immunomics program which embraces multi-faceted objectives with the purpose of identifying biomarker combinations that predict for patient response or resistance with immunotherapy centered therapeutic combinations.

Importantly, we devote great effort to bridge data between molecular and histopathology methodologies. These discoveries and our methods are available for collaborative efforts with our clients.

Contact us with any questions.