HistoBlast: China Edition September 2020

China is ready for Flow Cytometry and IHC!

It's appropriate to begin this newsletter with a "thank you." We are grateful for your encouragement and support for our endeavor in Jining, China. Our laboratory is operational for IHC and flow cytometry. Both IHC and flow cytometry clinical trial patient specimens arrive this month. Our highly experienced Chinese team is in place and we have completed numerous process milestones (e.g. HGRAC, Biosafety level 2 certification, import permits, etc.). For your Chinese clinical trial projects, you will enjoy the seamless workflow from proposal generation to data reporting supported by our local Chinese team. Thank you for committing your clinical trials into our hands. We are honored to have your trust and enthusiasm.


Histopathology

We are proud to announce that our IHC systems are now operational in Jining. The table above shows you the biomarker platforms and the respective assays that are planned for our Jining laboratory. As always, our platforms and systems are standardized globally, adhering to identical SOPs and processes. Please This email address is being protected from spambots. You need JavaScript enabled to view it. if you have questions about these assays or assays that you would like for us to establish.


MSD is Coming to Jining (Proteomics)

As part of the next phase of our laboratory set up in Jining, our cytokine assays, delivered on the Meso Scale Discovery (MSD) platform, will be transferred to Jining. This fall we will start the process to acquire the MSD instrument and in Q1 2021, train personnel and transfer the assays. Our current goal is to add cytokine assays to our CAP menu by Q2 2021.

Currently, HistoGeneX-Caprion offers three panels comprising a 29-plex assay, which has been qualified for exploratory analysis. For the 10-plex proinflammatory panel, a fit-for-purpose validation was conducted at our Montreal site to support primary endpoints to support monitoring of subjects for cytokine release syndrome (CRS). Currently, we are initially planning to offer all three panels at our Jining facility.

In addition to these off-the-shelf panels, we routinely assemble custom panels and work with our clients to validate the assays to the appropriate level required for the endpoint.

Contact This email address is being protected from spambots. You need JavaScript enabled to view it. for more information or to begin your planning!


Flow Cytometry (Immune Monitoring)

The BD FACSLyric™ Clinical System is now installed in Jining. This flow cytometry platform allows for up to 12-color analysis.

In August, our flow cytometry technologists trained on the BD FACSLyric™ platform and the MDSC Assay was successfully transferred in Jining. This assay measures the frequency of myeloidderived suppressor cells (MDSCs) in whole blood, providing an unrivaled view of the cellular immune response to cancer, determining potential immunosuppression of certain tumors to immunotherapies.

Please This email address is being protected from spambots. You need JavaScript enabled to view it. for your flow cytometry needs or specific applications, such as immunophenotyping of innate and adaptive cellular subsets, functional profiling of immune cells, or CAR T Cell characterization. Our scientists will be pleased to have these discussions and organize the implementation of these assays in our Jining laboratory


Genomics

We have initiated transfer of genomics services to Jining. Starting with DNA and RNA extraction, by November we will feature real time PCR services from FFPE material on the Rotor-Gene Q platform. Subsequently, real time PCR assays will also be available on the cobas® platforms. These instruments are identical to the platforms in our Belgian laboratory. Simultaneously, we are also setting up these genomics services at our US laboratory in Naperville. Our real time analyses of macrodissected-FFPE material is guided by our global network of pathologists. With our Chinese, US, and Belgian laboratories, our standardized global set up is ideally suited to support your global clinical trials.

Please This email address is being protected from spambots. You need JavaScript enabled to view it. to discuss your specific real time PCR assay needs.

We will also be setting up the Nanostring platform and will cover this in the next issue.


CAP Accreditation Application

We have received our customized CAP checklist and are securing our on-site inspection date, keeping on schedule with our laboratory timeline.

Import Permit

We are pleased to announce that we have received import approval of our comprehensive product list, which includes our commonly used reagents and tissue samples (both block and slides), as well as the permit for specific reagents, blocks, and slides. The turnaround time for each permit application is about 2 weeks.

These permits will allow us to continually import necessary reagents and specimens for our assay qualification and transfer, or from partner manufacturers. Additionally, this will enable us to transfer any control reagents from you (our sponsor) that may be required to set up your assay in Jining, reducing extended delivery times of some reagents ordered within China.

We will also be able to ship back the stained validation slides that we received from outside of China initially.

HGRAC

The Human Genetics Resources Administration of China (HGRAC) manages not only the export of genetic material in any form, but also the information or data related to these materials, even if the materials themselves are not exported.

Our US and BE facilities are now registered on the Chinese HGRAC platform. Specifically, we hold document support for projects related to:

  • HGX Belgium
  • HGX US
  • HGX China
  • Serametrix (wholly owned by HGX-Caprion)

Our HGRAC support services include application review and timely provision of required documentation. Thus far, we have supported 24 projects in which we reviewed and co-authored 10 official application forms. The first HGRAC approval for an awarded project in Jining comes at the end of this month. We also welcome conversations at the planning stages of HGRAC filing. For more information on our HGRAC services, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

"I can tell you are experienced with HGRAC even though you are a new lab."
- Study Manager, Global Pharma (July 2020)

Companion Diagnostics (CDx) Support Service in Jining

A Site Qualification Visit (SQV) is an important part of the CDx development process. Typically, a diagnostic manufacturer conducts a number of inspections at the biomarker service laboratory. We recently successfully completed our first SQV for a global diagnostic manufacturer at our laboratory in Jining.

"We are pleased to inform you that your site has been successfully qualified to participate in [our study]. With great support from Dr. Zhang, Michelle and other HistoGeneX-Caprion China colleagues, the visit went very well."
- Senior Clinical Research Manager, Global IHC Diagnostic Company (August 2020)

Do you have a WeChat account? Follow us as we establish ourselves in China. Please use this QR code to stay informed of our most recent updates. All materials posted will be written in Chinese to facilitate exchanges, but we welcome conversations in English and French.

For instructions on setting up your WeChat account and connecting to HistoGeneX-Caprion, please see here.

FAQs

Where can I find previous HistoBlasts? Find them here.

Have you seen the newest video of our laboratory space?

Meet our pathologists, Dr. Li-Jie Zhang and Dr. Zheng (Michael) Yuan.

What biomarkers have been validated at HistoGeneX? Our biomarker assays can be found here. This is not an exhaustive list. Please This email address is being protected from spambots. You need JavaScript enabled to view it. to confirm the availability of your assay.

For a conversation about our laboratory, please contact your project manager, business development executive, or This email address is being protected from spambots. You need JavaScript enabled to view it.. We invite you to download a copy of our latest presentation containing updates on our equipment and personnel. Please feel free to share and distribute to your internal organization.

You can send in additional questions This email address is being protected from spambots. You need JavaScript enabled to view it..