At Hematogenix, we are a full-service laboratory with multiple platforms. We accept many different specimen types. Download our up to date specimen requirements.

TECHNOLOGY
Our instrumentation and equipment are 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.

PCR
Hematogenix offers the industry-leading platforms and can validate kit-based mutation assays (BRAF, EGFR). 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.

We accept a broad range of specimen types:

• Peripheral Blood
• Bone Marrow Aspirates
• Liquid Specimens (e.g. Fine Needle Aspirate (FNA), Cerebrospinal Fluid (CSF))
• Fresh Tissue (e.g. Lymph Nodes, Bone Marrow Core Biopsy, Lung, Liver, Breast, Colon, Spleen)

CYTOGENETICS
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.

The programmed death 1 (PD-1) pathway has become a major focus of immunotherapy in many cancers. Multiple agents have progressed through clinical development in recent years, including antibodies targeting both PD-1 and its key ligand, programmed death ligand 1 (PD-L1).

We have consistently provided broad commercial access to high-quality PD-L1 testing. It is our continued mission to help our physicians identify the most appropriate treatment options for their patients.

Testing for PD-L1 expression at diagnosis provides actionable information that can be utilized to make treatment decisions across all lines of therapy. Studies show that testing helps to identify how well a patient is likely to respond to PD-1/PD-L1 immunotherapy.

Hematogenix offers all four FDA-approved tests to help our physician clients better understand their patient’s tumor which in turn provides insightful information for their treatment decisions.

• Clinically validated and reproducible
• Proven sensitivity and specificity
• Results available in 3-5 days

Test Name
PD-L1

Specimen Requirements Comments
FFPE Block
Formalin fixed paraffin embedded (FFPE) tumor block

Unstained Slides
If FFPE tissue block is provided as sections, a minimum of 5 unstained sections of 4-5 microns thickness should be provided. Sections must be mounted on positively charged glass slides (e.g. Superfrost Plus Micro Slides)

Fresh Tumor Biopsy
Biopsy should be fixed as close as possible to the time of excision and placed into 10% Neutral Buffered Formalin (NBF) Samples should remain in fixative for 4-48 hours at room temperature

Comments
Storage of samples at site should be kept at a temperature range between 15°C and 25°C.

Immediately ship samples to Hematogenix for further processing into FFPE blocks and testing.

If collected biopsy sample is not sent to Hematogenix on the same day, tissue samples should be transferred to a vial containing 70% ethanol following formalin fixation at site