Biomarker & Assay Development at Hematogenix Pharma Services

The value of biomarkers in drug development programs is indisputable. The added interest by the FDA and insurance companies in biomarkers has placed further emphasis on the discovery, development and use of biomarkers in drug development programs and ultimately, for matching patients with optimal therapeutics.

Hematogenix Pharma Services excels at validation of biomarkers in a post-discovery setting, when assays need to be transformed for translational and clinical stage deployment. Our biomarker programs are technology agnostic. The scientific experts in our organization and the processes we have developed enable us to rapidly assess and integrate novel technologies into our biomarker solutions. We rigorously maintain current know-how on validating technologies by consulting with academic groups, our network of pathologists and our extensive rapport with drug development teams globally.

Hematogenix biomarker assay development services especially excel when you require a rapid turnaround with potential complexity. Our flexible infrastructure, deep assay development experience and emphasis on project communication allow us to respond decisively.

At Hematogenix, we understand that assay development is the dynamic integration of core technologies with disciplined validation processes.


Our instrumentation and equipment is compliant with 21 CFR Part 11 requirements. Technologists are trained on GCP requirements.

Immunohistochemistry (IHC)

Hematogenix offers IHC automated instrumentation on platforms that are widely used. Multiple instruments are available to eliminate interruptions to patient recruitment that are being selected by your IHC assay.

Fluorescence In Situ Hybridization (FISH)

Hematogenix offers FISH testing for solid tumor and hematology specimens.  Automated slide preparation is available.  We enjoy discussing custom probe design for novel targets.

mRNA In Situ Hybridization

mRNA ISH is an alternative to quantitative PCR, with the benefits of morphological detail and standard brightfield microscopy assessment.  Hundreds of probes are commercially available, and Hematogenix can create custom probes for new targets or splice variants.


Hematogenix offers the industry leading platforms and can validate kit-based mutation assays (BRAF, EGFR, etc).  We will work with you to design a validation plan that probes the required limits of assay sensitivity for a specific project or application.

Image Analysis

Hematogenix uses digital pathology and image analysis technologies extensively. Our suite of digital tools enables us to develop objective and reproducible IHC assays for your project and conduct Web conferences with access to biomarker images.

Flow Cytometry

Our flow cytometry platforms are routinely used to phenotype blood cells for the diagnosis of blood disorders. Consult with us to employ these platforms for biomarker detection for your research and clinical trial needs. Our technicians are experts at various applications including rare event detection.


Our team utilizes fluorescent in situ hybridization (FISH) and other molecular methodologies to rapidly identify targeted chromosomes with suspected abnormalities in interphase cells as well as in metaphases. Our highly trained technical team employs a state of the art high speed scanner system and networked workstations to provide you valuable images and analyses.

Our Process

Our assay development and validation processes are the result of years of experience working with pharmaceutical partners.

Hematogenix assay development and validation is comprised of discrete processes that allow for flexibility of assay design.  Available options can span the full spectrum from specificity through reproducibility and analyte stability assessment, or a more limited scope that may include assay optimization and reproducibility.  The former situation could be custom development of a reagent and the latter could reflect a situation where the sponsor has specificity data on a reagent, but requires additional optimization to ensure robust performance.

Reagent, sample and operator information are recorded in worksheets that are associated with your specific project for ease in project review and sponsor audits.

Hematogenix welcomes audits from our sponsors. We request advance notice to ensure availability of relevant personnel.


Assay development projects at Hematogenix will be managed by a Project Manager, a Study Director and supported by our board-certified Pathologists and our experienced Scientific Team. It is the goal of this team to provide comprehensive support to develop the assay you require. Read more