HistoBlast: China Edition July 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.


Histopathology Update


Operationally, our Jining histopathology laboratory section is coming together nicely. Despite the challenges presented by COVID-19 measures, we have been able to meet target timelines and remain on schedule. We have retained a full laboratory team who are English speakers and have pharma biomarker service experience.

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Our personnel have undergone sample accessioning training using our global LIMs. In certain instances, we have successfully deployed remote training programs for our staff, adhering to our Quality Management System.

Our laboratory team speaks English, which has greatly facilitated training and procedure development. All training and documentation are in English

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Our sample reception is ready to receive blocks, slides, blood tubes and other forms of specimens.

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Some of our technologists were able to complete hands-on training in Belgium.


We are proud to announce that Dr. Zheng Yuan joined HistoGeneX-Caprion as the second pathologist on our team. We invited Dr. Yuan to share his thoughts of our company and oncology development in China.

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Dr. Zheng Yuan

What is your background in oncology drug development?
I joined a global CRO and worked in the anatomic pathology (AP) lab for 6 years. I was responsible for multiple IHC, ISH, and real time PCR biomarker assays for targeted therapy and immunotherapy programs, including PD-L1 (multiple clones), HER2, ER, PR, ALK IHC; ALK/MET/ROS1/FGFR1/ HER2 FISH; EGFR/ROS1 PCR, etc. I also participated in the assessment of tumor markers for global and local clinical trials, including dozens of Companion Diagnostic studies.

Previously, I worked in the hospitals as a pathologist for 12 years on both diagnostic pathology and research work, focusing on neoplastic disease. I reviewed 30,000 cases in multiple systems including lung, breast, urinary, H&N, digestive tract and lymphoma.

Why did you decide to join HGX-Caprion?
HistoGeneX-Caprion is a company on the leading wave of personalized medicine technologies. I am most excited by the company's foundation of a pathologist-driven, morphology-based approach to the research and development of new targeted therapeutic drugs and immunotherapy. As a pathologist, I am very honored to have an opportunity to engage in the field of precision medicine.

HistoGeneX-Caprion pioneers these global scientific and enterprising innovations by way of many novel technologies and platforms including multi-analyte IHC/IF, flow cytometry and genomic technologies that are so relevant to targeted and immunotherapy developments. The pathologists/scientists who are able to integrate numerical molecular data with visual morphological information create better solutions to make a difference in the lives of cancer patients. I look forward to my continuous growth with my new colleagues and our contributions to tumor treatment.

What are you looking forward to the most in the next 2-3 years?
HistoGeneX-Caprion China has just started. However, HistoGeneX-Caprion is indeed a veteran in this field, with a perfect global laboratory system, powerful executive team and professional pathologists and scientific teams. With this global support, I believe our Chinese team will develop rapidly. The interests of patients are paramount. It’s always our target to provide high quality biomarker testing services to our clients and patients.

 

Did you miss a previous interview with our staff? Learn more about some of our team.


Flow Cytometry Update


In June, we installed the BD FACSLyric™ Clinical System in Jining. We are pleased to announce the availability of this reliable and flexible platform, which allows for 12-color analysis. We are presently qualifying a panel of MDSC assays that has value in determining potential immunosuppression of certain tumors to immunotherapies.

Our flow cytometry technologists have been trained on the platform and are currently undergoing training to implement the MDSC flow cytometry assays. Please contact us for your other flow cytometry needs or specific applications, such as immuno-phenotyping panels or CAR-T development. Our scientists will be pleased to have these discussions and organize the implementation of these assays in our Jining laboratory.

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Global LIMS Communication


Our Global Laboratory Information Management System (LIMS), powered by StarLIMS, serves as the backbone for specimen management, test scheduling, and inventory tracking functions, allowing us to seamlessly manage global and complex clinical trials.

This system will be used for all histopathology and genomics projects in 2020. By the first half of 2021, the system will be used for all our specimen and assay management, including blood specimens for flow cytometry, MSD, or mass spectrometry services.

US - Belgium - China

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Samples: Effective management of samples and sample data
Inventory: Increased efficiency and productivity of the laboratory
Equipment: Global alignment of workflow standardization
Testing: Increased quality across all sites
Reporting: Increased security housed in an ISO-certified data center

Our Jining clinical operations, specimen reception, and laboratory technologists are trained on this system and will rely on its functionality to provide the services you have entrusted to us. We will provide further detailed updates on how this system will provide logistic, quality and efficiency benefits to you.


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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.


HGRAC Updates


Our HGRAC registration now extends to our Belgian laboratory for your clinical trial needs, and the US registration is forthcoming. In more than 10 projects, we have been designated as a Cooperative Party (either HGX-Caprion Belgium or China) as support to HGRAC applications. Some of these have been approved successfully and others are in progress. Our support service includes reviewing the application with comments and suggestions and providing required documents in a timely manner. 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..


Client Quotes for our China Lab


"Congrats on the progress!"

"What a beautiful lab! Hope to have the chance to visit your lab."

"We have had a very close collaboration with HistoGeneX Antwerp. It is good to see the HistoGeneX Caprion Lab in China opening soon! Looking forward to working with the China lab in the future."

 


For August 2020


In our next issue, we will provide the latest on:

  • Personnel, equipment, and processes
  • Biomarker menu updates and assay development
  • Genomics and Flow Cytometry updates

 

FAQs

Where can I find previous HistoBlasts? Find them here.

Have you seen the newest video of our laboratory space?

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..

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