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New test to detect proteins on cell lung cancer: Interview Special

By Tim Sandle     Oct 23, 2017 in Science
Antwerp - Researchers have presented new data from the BluePrint 2 project that demonstrates progress towards a standardized assay to detect PD-L1 proteins on non-small cell lung cancer. To understand more about this, we spoke with Christopher Ung of HistoGeneX.
The aim of the BluePrint 2 project is to lay the groundwork for studies that will help inform patients, physicians, pathologists, and others on how best to use the test results to determine treatment decisions in relation to lung cancer.
The project harnesses the latest in digital pathology and focuses on PD-L1 (programmed death-ligand 1) proteins. This is important since the upregulation of PD-L1 appears to allow some cancers to evade the host immune system.
The BluePrint 1 findings provided confidence that PD-L1 tumor scoring can be standardized among pathologists, which led to the BluePrint 2 phase of the project. One company that played a pivotal role in the project was HistoGeneX Global Laboratories, which undertook staining of antibody clones. Each of the clones were immunostained on either a Dako or Ventana platform at the company's premises in Antwerp, Belgium.
Following whole slide scanning of the stained slides, the images were then uploaded to HistoGeneX's pathologist training platform (PathoTrainer). The training of participating BluePrint 2 pathologists was conducted on this platform via on-site and remote mechanisms. Dr. Mark Kockx, founder and pathologist at HistoGeneX, pioneered the effort on the web-based training tool and he also served as principle trainer for participating pathologists. The concordance of the pathologist reads were also measure against his reads as a reference standard.
To find out more, Digital Journal spoke with Christopher Ung, who leads the development and execution of HistoGeneX’s strategic and business initiatives, leveraging the company’s solid tumor and anatomic pathology services.
Mr. Christopher Ung has served in the companion diagnostics field since its inception and is one of ...
Mr. Christopher Ung has served in the companion diagnostics field since its inception and is one of the original pioneers of the personalized medicine field.
Digital Journal: Thank you for the interview. What are the current limitations with lung cancer detection?
Christopher Ung: The BluePrint 2 (BP2) data is centered around finding the best patients who might benefit from PD1/PD-L1 immunotherapies.
DJ: How does your technology improve upon this?
Ung: Our technology allows us to accurately identify patients whose tumors and immune cells express PD-L1 protein. This checkpoint protein is activated by the tumor cells to evade the body's immune response. Patients whose tumors express this protein may benefit greatly from PD1/PD-L1 immunotherapies which have recently been FDA-approved.
DJ: What are the aims of the BluePrint2 project?
Ung: There were two important conclusions. [First] there are some differences between the PD-L1 immunohistochemistry (IHC) tests. Two of them in particular have slightly different characteristics.
[Second] reading on digital slides versus glass slides in this setting is remarkably equivalent. The reading on digital slides have been a concern in this industry.
DJ: What progress has been made to date?
Ung: Immunotherapies have made a huge difference in lung cancer even though it's such a daunting disease type. The diagnostics of immunotherapies is also improving as the scientific community begins to understand the details of PD-L1 diagnostics.
DJ: Why is the focus on PD-L1 proteins important?
Ung: PD-L1 is a checkpoint receptor which is essentially a brake for the immune system. An uncontrolled immune system leads to autoimmune or systemic flare up. But cancer cells activate this checkpoint receptor for their own preservation, essentially evading the immune system. Not all cancers utilize this mechanism however. By understanding which cancers have taken advantage of the PD-L1 brake, the immunotherapies are not "wasted" on patients who will not derive benefit. Hence, the importance of PD-L1 diagnostics. Hence, Blueprint.
DJ: What are the assay run times?
Ung: There are 5 commercial assays. The turnaround time from receiving the specimen in the laboratory is usually around 3-5 days.
DJ: How accurate are the assays? What is the margin of error?
Ung: This is essentially the focus of BP2. There are differences in the 5 commercial PD-L1 IHC assays and it's important to understand why.
DJ: How do you hope to commercialise the assays?
Ung: We are a service lab. We operationalize and perform the assays. We were selected by the BP2 committee as a neutral party to perform the assays. The assays are commercialized by Dako and Ventana.
DJ: What is the regulatory strategy?
Ung: Except for 7310, the other tests have received U.S. FDA approval. Because of PD-L1, the FDA created a supplemental category called Complementary Diagnostics to go with Companion Diagnostics. This has lots of implications for the developers and manufacturers of both assays and therapies.
DJ: What has been the interest from the medical profession?
Ung: High. But oncologists and pathologists are confused by the multiple clones that appear to do the same thing but don't.
DJ: Are there any other projects you are working on intend to begin in the near future?
Ung: Lots. Digital pathology. Multiplex Immunohistochemistry. RNA Sequencing, Circulating Tumor Cells. I will be giving a presentation on October 27, 2017 in Porto Portugal at the Biotech Pharma Summit: Companion Diagnostics and Biomarkers.
HistoGeneX Laboratories is an accredited global laboratory system located in Antwerp, Belgium and Naperville, IL, U.S. HistoGeneX serves pharmaceutical and biotechnology drug development sponsors and functions as a diagnostic laboratory for oncology offices worldwide.
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