From discovery candidate
to clinical decision
QF-Pro® applications cover the full translational pipeline: from preclinical mechanism-of-action and pharmacodynamic studies, through cohort-scale biomarker validation in translational programmes, into companion diagnostic development inside clinical trials, and ultimately routine diagnostic pathology.
QF-Pro® across the translational pipeline
Preclinical
validation
- Mechanism-of-action studies
- Pharmacodynamics
- Target engagement
Translational research
- Cohort-scale biomarker validation
- Multi-omics validation
- Functional biomarker characterisation
Clinical trials
- Patient stratification
- CDx co-development
- Regulatory-grade evidence package
Clinical diagnostics
- Routine anatomical pathology
- IVD pipeline deployment
- Predictive, prognostic, and diagnostic decisions
1. Preclinical research
Studies for target engagement, dose-response, and mechanism of action
QF-Pro® delivers a direct quantitative readout of target engagement, receptor occupancy, and inhibition or activation states in fixed cell models and tissue, including xenografts, PDX, and organoids. Dose-response curves, head-to-head lead evaluation, and mechanism confirmation for next-generation therapeutics such as ADCs, bispecifics, TKIs, and immunomodulators based on the same standardisable, reproducible measurement.
The measurement does not change downstream; QF-Pro® delivers continuous evidence from preclinical work all the way through cohort validation and clinical trials.
2. Translational research
Validation of discovery hits at the cohort scale
QF-Pro® helps validate the clinical utility of potential biomarkers. It quantifies the functional protein states behind those candidates directly in cohort-scale FFPE samples, turning a discovery hypothesis into a measurable, robust, and comparable readout.
The assay is standardisable and reproducible, supporting validation across hundreds of patients, multiple sites, and heterogeneous regions of interest. Biomarkers become functional and ready for clinical trials, companion diagnostics, and IVD development.
3. Clinical trials and companion diagnostics (CDx)
Selection of the right patients for the right therapy.
QF-Pro® measures the functional or mechanistic state of the drug target in patients’ biopsies to deliver a CDx-grade quantitative readout that supports patient selection in clinical trials. Upon approval, it becomes the companion diagnostic.
The workflow is fully integrated and independent of staining variability, imaging settings, and operator effects, so measurements are reproducible across sites and operators. This continuity carries the biomarker through clinical trials, CDx approval, and later routine diagnostic use, all on the same assay.
4. Clinical practice / IVD
Quantitative diagnostics at a routine scale
HAWK Biosystems’ IVD pipeline is fully compatible with the anatomical pathology workflows hospitals already use, bringing functional, quantitative biomarkers into a routine that today relies on intensity-based, semi-quantitative methods. Every QF-Pro® report is a standardisable numerical score with defined cut-offs, readable in the same way across institutions, regions, and clinical teams.
The pathologist reads it. The clinician acts on it. The patient receives a result that shapes their treatment.
QF-Pro® across the translational pipeline
Preclinical validation
- Mechanism-of-action studies
- Pharmacodynamics
- Target engagement
1. Preclinical research
Studies for target engagement, dose-response, and mechanism of action
QF-Pro® delivers a direct quantitative readout of target engagement, receptor occupancy, and inhibition or activation states in fixed cell models and tissue, including xenografts, PDX, and organoids. Dose-response curves, head-to-head lead evaluation, and mechanism confirmation for next-generation therapeutics such as ADCs, bispecifics, TKIs, and immunomodulators based on the same standardisable, reproducible measurement.
The measurement does not change downstream; QF-Pro® delivers continuous evidence from preclinical work all the way through cohort validation and clinical trials.
Translational research
- Cohort-scale biomarker validation
- Multi-omics validation
- Functional biomarker characterisation
2. Translational research
Validation of discovery hits at the cohort scale
QF-Pro® helps validate the clinical utility of potential biomarkers. It quantifies the functional protein states behind those candidates directly in cohort-scale FFPE samples, turning a discovery hypothesis into a measurable, robust, and comparable readout.
The assay is standardisable and reproducible, supporting validation across hundreds of patients, multiple sites, and heterogeneous regions of interest. Biomarkers become functional and ready for clinical trials, companion diagnostics, and IVD development.
Clinical trials
- Patient stratification
- CDx co-development
- Regulatory-grade evidence package
Clinical diagnostics
- Routine anatomical pathology
- IVD pipeline deployment
- Predictive, prognostic, and diagnostic decisions
Repertoire of validated biomakers
Protein-protein interactions (PPIs)
- PD-1 / PD-L1
- CTLA-4 / CD80
- TIGIT / CD155
- LAG3 / MHC-II
- TIM3 / Gal9
- OX40 / OX40L
- PD-1 / SHP-2
- HER2 / HER3
- HER2 / EGFR
- HER3 / EGFR
- PKB / PDK1
- Beta-catenin / E-cadherin
Post-translational modifications (PTMs)
- Akt / PKB activation state (pT308)
- STAT3 activation state (pY705, pS727)
- EGFR activation state (pY1068)
- Rb activation state (pS807/811)
The QF-Pro® biomarker catalogue is broader and continues to expand. Additional validated and in-development assays are available on request.
at any stage of your pipeline
We are constantly seeking to collaborate with clinicians, researchers and academics.