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View this email in your browser October 2016 Histo Highlights TransAtlantic Biomarker Laboratory Builds The projects that you have been presenting to us have been increasing in scope, size, and novelty. To keep pace, HistoGeneX is in full building mode on both sides of the Atlantic. We are committed to using one quality system, one LIMs, and one project management system. Both our labs will have the necessary CAP, CLIA, and GLCP credentials. Some of you have visited our facilities—thank you for that; your support and enthusiasm have been motivating. In Antwerp, our 40,000 square foot home is underway. It will house our entire team—our laboratory sections, clinical operations teams and pathologists—with a 10,000 square foot storage space in the basement! We begin our migration March 2017. Meanwhile, in Naperville, we have settled in our 5000 square-foot Phase I location. Our site now provides accessioning, sectioning, histology, IHC and digital pathology services. By year’s end, we will be able to extract DNA and RNA from FFPE routinely processed tissue. We have local project managers to offer our US collaborators time-friendly and time-sensitive project oversight. Please contact us to schedule a visit. HistoGeneX Scientific Press Vessel Co-Option: A Novel Therapeutic Target in Metastatic

Histo Highlights - histogenex.com · October 2016 Histo Highlights TransAtlantic Biomarker Laboratory Builds The projects that you have been presenting to us have been increasing

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Page 1: Histo Highlights - histogenex.com · October 2016 Histo Highlights TransAtlantic Biomarker Laboratory Builds The projects that you have been presenting to us have been increasing

View this email in your browser

October 2016

Histo HighlightsTransAtlantic Biomarker Laboratory BuildsThe projects that you have been presenting to us have been increasing in scope, size, andnovelty. To keep pace, HistoGeneX is in full building mode on both sides of the Atlantic.We are committed to using one quality system, one LIMs, and one project managementsystem. Both our labs will have the necessary CAP, CLIA, and GLCP credentials.

Some of you have visited our facilities —thank you for that; your support and enthusiasmhave been motivating.

In Antwerp, our 40,000 square foothome is underway. It will house ourentire team—our laboratorysections, clinical operations teamsand pathologists—with a 10,000square foot storage space in thebasement! We begin our migrationMarch 2017.

Meanwhile, in Naperville, we havesettled in our 5000 square-footPhase I location. Our site nowprovides accessioning, sectioning,histology, IHC and digital pathologyservices. By year’s end, we will beable to extract DNA and RNA fromFFPE routinely processed tissue. Wehave local project managers to offerour US collaborators time-friendlyand time-sensitive project oversight.

Please contact us to schedule a visit.

HistoGeneX Scientific Press

Vessel Co-Option: A Novel Therapeutic Target in Metastatic

Page 2: Histo Highlights - histogenex.com · October 2016 Histo Highlights TransAtlantic Biomarker Laboratory Builds The projects that you have been presenting to us have been increasing

Colorectal CarcinomaThis stimulating, newly published Nature Medicine article by our very own Peter

Vermeulen, together with his colleagues, report on the rationale of combining anti-

angiogenic inhibitors with vessel co-option inhibitors. In tandem this therapeutic

combination represents a warranted therapeutic strategy for patients struggling with

metastatic colorectal or breast cancer.

Measuring Microvessels in Whole-Slide ImagesThe application of image analysis on whole-slide images is a utility with great promise for

clinical development. We continue to invest energy and research in these efforts and are

pleased to present this paper that describes our methodology of measuring microvessels

in the cancer tumor microenvironment.

The Validation Chasm Between Glass and DigitalThe transition from optical glass slide reads to digital slide reads is replete with discussions

Page 3: Histo Highlights - histogenex.com · October 2016 Histo Highlights TransAtlantic Biomarker Laboratory Builds The projects that you have been presenting to us have been increasing

and discourse. Interested in helping us transition the gap? Join the conversation. We shareour validation & operational thoughts at the 2016 Pathology Visions conference in SanDiego.

Digital Pathology in the Immuno-Oncology Field – A Roadmap for the FutureChristopher Ung, Mark Kockx, Yannick Waumans (2016)

Digital Pathology in the Immuno-Oncology Field – A Roadmap for the Future

2016 Pathology Visions Conference, Digital Pathology Association

Exhibit Hall, Poster P9

Sunday, October 23 – Tuesday, October 25, 2016

PD-L1 Expression in MelanomaWe add to the knowledge repository of PD-L1 IHC staining with this publication comparing

the SP142 to E1L3N clones. Our scientists study the expression of these clones in

malignant melanoma and also compare the results with mRNA ISH expression.

Development of Small Fiber Neuropathy Biomarker TestsSmall fiber neuropathy manifests in a variety of different diseases and often results in

painful symptoms for the cancer patient. Diagnosis is mainly through clinical examination

and historic findings, which can be rather subjective. In these two papers, our scientists at

HistoGeneX report on the development of two biomarker assays—PGP9.5 and NRP-1

receptor—that are associated with small fiber neuropathy.

Page 4: Histo Highlights - histogenex.com · October 2016 Histo Highlights TransAtlantic Biomarker Laboratory Builds The projects that you have been presenting to us have been increasing

Our New Pathologist – Pioneer & Practitioner

As our client, you have emphasized to us

the importance of our pathology

knowledge. We engrain this into our

operational thinking, embracing actions to

strengthen and solidify this position,

including the addition of knowledgeable,

expert pathologists who are also excellent

collaborators. We are pleased to introduce

the newest addition to our scientific team.

Peter Vermeulen M.D, Ph.D. is

Principal Investigator for various

studies. He is certified in multiple

subspecialties and has deep clinical (esp.

breast cancer) and research (esp.

tumor vascularization) experience. His

upcoming publication in Nature Medicine

is posted above.

Page 5: Histo Highlights - histogenex.com · October 2016 Histo Highlights TransAtlantic Biomarker Laboratory Builds The projects that you have been presenting to us have been increasing

unquestionably a strengthening asset and

we are thrilled he has joined the

HistoGeneX family. He spans histological

and molecular technologies, has authored

nearly 200 publications, and carries an

impressive academic record from the

University of Antwerp. Peter will lead our

Patho-Imaging laboratory section and will

also serve as a

Spotlight on our Science

The Not So Micro-Complexity of the PD-L1 EnvironmentThe PD-L1 environment is about as complex as any tumor microenvironment we

encounter, isn’t it? We have been answering the following questions from you:

What are the differences between the clones?

Which tumor types do these clones work with?

What are the cutoffs? What experiences do we have with these cutoffs?

What are our experiences with the RUO, ASR, IUO and IVD versions of these

assays?

Are HistoGeneX pathologists trained for the different cutoffs and tumor types?

We have validated the FDA-approved PD-L1 IHC assays using multiple cutoffs and on

various tumor types.

Contact us for your PD-L1 needs or if you would like to discuss the above questions.

We stand by to share our experience.

Page 6: Histo Highlights - histogenex.com · October 2016 Histo Highlights TransAtlantic Biomarker Laboratory Builds The projects that you have been presenting to us have been increasing

An Evaluation of Formical 2000

Molecular techniques now form the cornerstone of clinical pathology for therapy responseand tumor prognosis. However, various molecular read-outs can be subject to variationsdue to the so called “pre-analytical” phase and can bias the interpretation of the results.In particular, bone, a common site of metastasis, requires decalcification prior to using thetissue for further processing. However, commonly used decalcification agents usuallycontain strong acids that degrade nucleic acids.

Formical 2000, when compared against MOLDecal and NBF (control), produced equivalentresults for histology and IHC (example with CD138).

However, this was not the case when the fixed specimens were used for a PCR experimentwhere the use of Formical 2000 produced substantial inhibition of PCR amplification.

We conclude that Formical 2000, while usable for histology and IHC, is not suitable forPCR molecular analysis. The MOLDecal Bonestation methodology is the preferred methodfor molecular PCR work.

For a technical, detailed description of the procedure, please contact us.

Immuno-Oncology Biomarkers & MoreOur assay development team is actively validating new IHC biomarkers for clinicaldevelopment use, including those for immuno-oncology. Visit our website for an updatedlist and review our IHC assay development process.