histo highlights - histogenex
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July 2016
Histo HighlightsMidway through 2016, HistoGeneX is busily building both laboratories and novel services. In
this issue, we share news of our Chicago laboratory and innovative immune-oncology
development services.
Thank you very much for your partnership, we enjoy learning and discovering with you.
HistoGeneX in Chicago
Our new Chicago-area laboratory, located in Naperville, IL, is HistoGeneX's first expansion beyond
Europe. Our laboratory philosophy is simple yet profound. We aim to maintain the same quality, the
same processes and the same interactions that you have come to expect. This manifests through
scrupulous adherence to our processes, mimicking in great detail all methods and materials to
minimize any procedural drift and also through inter-laboratory staff exchange to ensure
communication is efficient and well-translated. This endeavor is simple in concept but intricate in
deployment, and indispensable.
In 2016, our Chicago laboratory can accession your specimens, stain H&E slides, conduct IHC
testing, section slides (for both histology and molecular extraction) and digitally capture high
resolution, whole slide images. We will ship to our Antwerp laboratory for tests that are not yet
available at our Chicago laboratory and manage those logistics for you.
PD-L1, PD-L1 or PD-L1?
Three regulatory-approved PD-L1 IHC assays are now commercially available. Despite harmonizationintent through projects like the Blueprint Initiative, there is wide acceptance that these antibodieshave different expression characteristics on tumor and immune cells. These options expand evenfurther for clinical research use. HistoGeneX has validated the three regulatory-approved PD-L1 IHCassays on their corresponding automated platforms. We have also rigorously validated the antibodiesthat are presently limited to clinical research applications. Contact us if you are interested incomparison studies of these clones on target tumor entities or if you have questions about theimmune and tumor cell expressions of specific clones.
Clone SP263 - Ventana - Durvulamab - Not approvedClone SP142 - Ventana - Atezoluzumab - Approved as complementary DxClone 28-8 - Dako - Nivolumab - Approved as complementary DxClone 22C3 - Dako - Pembrolizumab - Approved as companion DxClone E1L3N - CST - Research Use Only
HistoGeneX Performs PD-L1 Testing for Atezolizumab Bladder CancerTrial
The recent FDA approval of Atezolizumab, a PD-L1 inhibitor, is of tremendous import to bladdercancer patients. We are honored to have the opportunity to contribute to the central testing of PD-L1using Ventana's SP142 clone.
Lancet 2016; 387: 1909-20
Virtual Multiplexing - Understanding the TumorMicroEnvironment (TME)An emerging tissue digital pathology technology virtually superimposes multiple IHCimmunostains into a single image, allowing for simultaneous assessment of targetantigens and their respective geo-locations within the TME. In this application, up to siximmunostains on serially-registered sections are combined using software thatsynchronizes the digital terrain of the slides. By designating the central section of theserially-registered slides to an anchor biomarker, e.g. cytokeratin as a marker ofcarcinoma, the TME can be dissected into tumor versus stroma, and subsequentexpression of infiltrating lymphocytes can be observed within each of those sectorsrespectively. Contact us to find out how we deploy this technology such as theapplication below.
Automated mRNA In Situ Hybridization (ISH)
mRNA ISH is an exciting alternative/parallel technology to IHC especially for low abundance or IHC-compatible targets, however, its potential is dampened by the reproducibility of the technology whenused manually. Recently, we completed the evaluation of this technology on the Leica Bond Rx, anautomated platform for mRNA ISH applications such as the ones showed below. Contact us todiscuss the methods and conditions for using this technology in your development programs.
View RNA on Rat Kidney Tissue (FFPE)
KRT8/KRT14 mRNA ISH probes define epithelium-derived carcinoma.
RNAScope Staining in Combination with Tyramide Amplification - Immunofluorescence on HeLa Cell Controls
A Bone to PickDecalcification is a necessary process to prepare tissue sections from bone-containing specimens. Common decalcification agents, however, contain strong acids thatdegrade RNA & DNA which compromise the use of subsequent applications such as nextgeneration sequencing, gene expression, and real-time PCR. We validated BoneSTATIONwhich uses MOL-Decal, an EDTA-based soft decalcifier (Milestone, Italy, EU) that preservesthe decalcified specimen for use with downstream molecular applications against the goldstandard decalcifier acetic acid zinc formalin (AZF) and neutral-buffered formalin (NBF) ascontrols. Using human tonsil specimens, we confirmed that BoneSTATION producedequivalent RNA and DNA quality and quantity measurements to NBF, while AZF yielded inferiorDNA quality and quantity measurements. Furthermore, we confirmed that specimens fixed inBoneSTATION produced uncompromised IHC, FISH and Special Stain results across severalanalytes. We tested the following assays using this decalcification protocol.
H&EImmunohistochemistry (IHC): CD3, CD8, Ki67, CD20, CD34, CD138, BCL-2, Cyclin D1,FOXP3, CD38, MHC Class I and CD163GiemsaHER2 FISHNucleic Acid quality and quantity
Immune-Oncology Biomarkers & More
Our assay development team is actively validating new IHC biomarkers for clinical development use,
including those for immune-oncology. Visit our website for an updated list and review our IHC assay
development process.
Our Immunotherapy Biomarker Publication
We invite you to take a look at our February 2016 paper where we describe our HistoOncoImmune
methodology to characterize immune activity in the patient's tumor microenvironment. This system
integrates histopathology information with molecular data that can provide insights for clinical
development.
Get additional updates through our HistoGeneX Website, LinkedIn and Twitter.
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