Kirsty Maclean Ph.D.
It’s clearly a very timely discussion with many recent articles reviewing the complexities of the tumor microenvironment and overall tumor heterogeneity that have been implicated in late-stage clinical failures, underscoring an urgent need for tests that accurately predict response to the growing number of available therapies. This podcast sought to examine some of these issues and address many questions such as the need for tissue multiplexing, how much information multiplexing can add above and beyond single marker approaches or to other histologic features. What about diminishing returns and what are the challenges to implementation? What about the increased system complexity that comes with multiplexing? What about system failure?
Kirsty Maclean Ph.D.
The podcast began with a review of Vizgen’s innovative InSituPlex® staining technology and service offerings enabling key insights into the tumor microenvironment as well as what makes these workflows so unique, by outlining the differences between single marker IHC approaches and other techniques such as FISH and addressing the importance of standardization and reproducibility.
InSituPlex enables whole slide multiplexed immunofluorescence and H&E
One of the exciting areas of opportunity for integrating digital pathology is the journey from biomarker/drug discovery to drug approval to implementation in clinical practice and then, of course, one arena for future developments in diagnostics is a multiplexing-based companion diagnostic. Dr. Wharton noted that while “I don’t think the field is there quite yet”, we’re instead “at the stage where we’re using the technology to help our customers get a better understanding into simply what they’re seeing in tissue.” Dr. Wharton pointed out that while digital pathology studies are often done on retrospective cohorts, large tissue collections with outcome data present an opportunity to generate and test hypotheses leading to deeper clinical insights.
The podcast finally reviewed other topical areas such as the role of deep learning, AI and integration of more traditional methods such as H&E and ultimately speculated on the possibility of digital pathology as the platform of choice for an integrated clinical diagnostic that incorporates molecular data (e.g. DNA hybridization), multiplexed protein detection, and tissue features derived from methods such as H&E staining. The opportunity that these evolving innovative methods will bring, especially to the arena of immunotherapeutics, will mark significant changes in the field in the coming years.
There’s lots more, to listen to the full podcast:
Dr. Joseph Anderson – Host of Digital Pathology Today™
Dr. Joseph Anderson is a consultant to early stage and mature companies in the digital pathology and molecular diagnostics space. Previously, he oversaw the clinical pathology group at Genomic Health as the Oncotype Dx Breast cancer assay grew to a volume of over half a million tests. He was also involved in the development of new products, including assays for DCIS, Colon Cancer and one of the first commercially available liquid biopsies. He served the College of American Pathologists on the Molecular Oncology Committee, with responsibility for proficiency testing in biomarkers for lung cancer in the United States and across the world and as member the House of Delegates representing California. He has served in several working groups and committees for the American Medical Association for CPT coding and reimbursement and assessment of new technologies such as next-generation sequencing. Upon graduating from the University of Minnesota Medical School, he completed residency in Anatomic and Clinical Pathology at Rush University, fellowship in Oncologic Pathology at Fox Chase Cancer Center and post-doctoral training in Molecular diagnostics at UCSF. He initially worked in private practice, credentialed at 17 various hospitals and surgery centers.
Keith Wharton, Jr., MD Ph.D. FCAP – Vice President, Medical Director, Ultivue Inc.
Keith is a board-certified anatomic pathologist with diverse achievements in research and drug/diagnostic development. Leading Ultivue’s Assay Services Laboratory, he brings expertise in investigative pathology, multiplex microscopy and imaging, and digital pathology to our customers striving to realize the promise of personalized medicine. Most recently he was Senior Medical Director of Leica Biosystems, and prior to that he led and supported R&D, toxicology, biomarker, and clinical study teams in multiple therapeutic areas at Novartis and Biogen. He earned a BS in Chemical Engineering from the University of Arizona, and MD and PhD in Molecular Biology from UCLA, where he discovered the molecular basis of DNA recognition by bHLH-PAS transcription factors. Following residency and postdoc at Stanford, his lab at UT Southwestern characterized the Naked cuticle (Nkd) gene family as feedback regulators of Wnt-beta catenin signaling.