BluePrint Phase 2 Demonstrates Digital Pathology Review Equivalent to Glass Slides

YOKOHAMA, Japan, Oct. 17, 2017 (GLOBE NEWSWIRE) — The BluePrint Phase 2 committee today presented its findings comparing five PD-L1 IHC assays at the International Association for the Study of Lung Cancer (ISALC) 18th World Conference on Lung Cancer (WCLC) in Yokohama, Japan. In this landmark study, a follow-up to BluePrint 1, a global team of thoracic pathologists reviewed the immunostains of five clinical grade PD-L1 IHC assays (22C3, 28-8, SP142, SP263, and 73-10). Among the conclusions, the committee revealed data demonstrating that digital pathology review shows convincing equivalence to glass slides.

HistoGeneX Global Laboratories performed the staining of these antibody clones. Each of the clones were immunostained on either the Dako (22C3, 28-8, 73-10) or Ventana (SP142, SP263) platforms at its 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. Following initial training, pathologists submitted their formal review of all cases via the PathoTrainer™ platform.

“The standardized HistoGeneX processes of immunostaining, scanning and the PathoTrainer™ system provides a controlled set of platforms to assess the staining and review of these important PD-L1 assays,” said Ming Tsao, Chairman of the BluePrint 2 committee and Professor of Laboratory Medicine and Pathobiology at University of Toronto. “An intriguing conclusion from BluePrint 2 is that PD-L1 tumor cell scoring on digital images and glass slides show comparable reliability,” added Tsao. In BluePrint 2, each pathologist scored all 5 assays, two assays by glass and three assays digitally.  The review by digital slides closely parallels those from glass slides.

“This BluePrint 2 observation is exceedingly encouraging. Having systems like the PathoTrainer™ platform allows us to efficiently operationalize such comparisons, provide training and proficiency testing in a constantly evolving environment,” said Keith Kerr, who serves as co-chair for BluePrint 2 and is a pathologist at Aberdeen University Medical School in Scotland.

HistoGeneX pathologist and founder, Mark Kockx, participated as a pathologist reviewer and the designated trainer. “The BluePrint 2 findings provide confidence that PD-L1 tumor scoring can be standardized among pathologists. However, we have more work to do to standardize scoring on immune cells. The PathoTrainer™ platform allows us to accelerate such endeavors. We look forward to developing these investigations further with the BluePrint initiative.”

About the Blueprint Project

In March 2015, the AACR, in partnership with the U.S. Food and Drug Administration and the American Society of Clinical Oncology, held a one-day workshop to examine whether multiple companion diagnostics intended for the same class of therapeutics could be harmonized. During the workshop, a group of four pharmaceutical companies and two diagnostic companies released a Blueprint proposal to analytically compare and characterize each of their IHC-based PD-1/PD-L1 companion diagnostics for non-small cell lung cancer in the pre-approval stage. The thought was that, upon approval of these tests, the information generated by this project could lay the groundwork for additional studies that will help inform patients, physicians, pathologists, and others on how best to use the test results to determine treatment decisions. BluePrint 2 set out to validate the comparability results of Blueprint phase 1 for the 5 assays with a larger cohort of lung cancer specimens and with a larger consortium of international pathologists, BluePrint 2 also sought to assess concordance of PDL1 scoring using light microscopy versus digital reads using a web system.

About HistoGeneX

HistoGeneX Laboratories ( is a CAP, CLIA, and BELAC—accredited global laboratory system located in Antwerp, Belgium and Naperville, IL, USA. HistoGeneX serves pharma and biotech drug development sponsors and functions as a diagnostic laboratory for oncology offices worldwide.

All HistoGeneX services and products stem from a pathology and patient care perspective. We expertly handle human biological specimens and employ innovative technologies to analyze and understand cancer for research and diagnostic applications. Our deep pathology foundation brings a real-world approach to drug development biomarker programs—a critical element within personalized medicines such as immunotherapy.

HistoGeneX Laboratories employs multiple PMA-class companion diagnostic programs. Our leadership has created and participated in the industry’s most significant targeted and immunotherapy biomarker programs in order to provide the highest quality products and services to our customers.

Chris Martin

Christopher Ung
Chief Business Officer