ALK Testing in NSCLC: Challenges and Advances


Personalized medicine has become part of routine practice in oncology, as illustrated by the use of EGFR and ALK testing for selecting targeted therapies in non-small-cell lung cancer (NSCLC). Dr. Stephan Morris, who discovered ALK gene abnormalities that drive cancer, will describe the role of ALK fusions in NSCLC and the available ALK detection assays. Dr. David Saltman will discuss his clinical experience in NSCLC patient management, and how ALK assays including fluorescence in situ hybridization (FISH), immunohistochemistry (IHC), and RT-PCR can be used systematically in a clinical testing algorithm.

The objectives of this session are to:
  • Provide background about an identified druggable target in NSCLC — anaplastic lymphoma kinase (ALK)
  • Describe clinical diagnostic approaches for the efficient and reliable detection of ALK fusions in NSCLC
  • Describe current clinical oncology practice and NSCLC workflow
  • Illustrate a case report regarding ALK detection in low tumor content lung biopsies using an ALK RT-PCR assay
  • Inform participants about the PCRTALK trial: A head-to-head study comparing IHC, FISH and ALK RT-PCR in NSCLC

Dr. Stephan Morris

Stephan Morris

Dr. Stephan Morris is a board-certified internist and medical oncologist who received his training at UT Southwestern Health Science Center – Dallas and Yale University School of Medicine. For 25 years, Dr. Morris was a faculty member at St. Jude Children’s Research Hospital, where he and his research team published over 125 peer-reviewed publications describing the discovery of a number of oncogenes,including anaplastic lymphoma kinase (ALK), B-cell lymphoma/leukemia gene 10 (BCL10), nucleophosmin-myeloid leukemia factor 1 (NPM-MLF1), RNA-binding motif 15-megakaryoblastic leukemia 1 (RBM15-MKL1), mixed-lineage leukemia-ALL1 fusion 15q (MLL-AF15q) and others.

Dr. Morris is the Scientific Founder and Chief Scientific Officer of Insight Genetics (www.insightgenetics.com). Dr. Morris helped to direct the company’s development of a qPCR assay to detect oncogenic expression of ALK. This assay is currently manufactured and distributed by QIAGEN as the ALK RGQ RT-PCR Kit and is being utilized by academic and commercial clinical labs worldwide.

Dr. David Saltman

David Saltman

Dr. David Saltman is a staff medical oncologist at the British Columbia Cancer Agency and former Chair and Professor of Oncology at Memorial University of Newfoundland. He obtained a PhD in cancer cell biology from the Medical Research Council Human Genetics Unit in Edinburgh, Scotland and has a postdoctoral fellowship in Molecular Cytogenetics from Stanford University. In 1994, Dr. Saltman was part of a team of researchers led by Dr. Stephan Morris that cloned the non-randomly occurring t(2:5)(p23;q35) translocation breakpoint in anaplastic large cell lymphomas leading to the discovery the anaplastic lymphoma kinase (ALK) gene. Dr. Saltman is the principal investigator of the PCRTALK trial, which is study comparing the use of a qPCR-based assay to immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) in the detection of anaplastic lymphoma kinase (ALK) fusions in formalin fixed paraffin-embedded (FFPE) tissue from non-small cell lung cancer (NSCLC) patients.