Medicare approves GatewaySeq test for solid tumors

GatewaySeq, a cancer sequencing test developed at Washington University School of Medicine, has received approval from the Centers for Medicare and Medicaid Services (CMS). CMS approval for GatewaySeq marks a milestone for test developers, including Eric Duncavage, MD, Professor of Pathology and Immunology; Lulu Sun, MD, PhD, Assistant Professor of Pathology and Immunology; Drew Hughes, MD, PhD, Assistant Professor of Pathology and Immunology; and David Spencer, MD, PhD, Associate Professor of Medicine, who created a rapid, inexpensive panel designed for initial diagnosis, prognosis, and therapy selection in most solid tumors, helping patients and clinicians make important decisions sooner.

GatewaySeq is meant to be used as a frontline assay to quickly identify common clinically significant mutations and actionable genomic markers to help guide treatment decisions, said Dr. Sun. The test was developed by a multidisciplinary team including researchers and staffs from the Department of Pathology and Immunology; the Department of Medicine; and the McDonnell Genome Institute, where sequencing for GatewaySeq is performed. Washington University surgical and molecular pathologists and the Anatomic and Molecular Pathology (AMP) Lab in the Department of Pathology handle tissue selection, sequencing interpretation, and reporting for GatewaySeq testing.

Currently, GatewaySeq testing is available at all hospitals that use Washington University Pathology Services including Barnes-Jewish Hospital and Siteman Cancer Centers. The recent CMS approval sets the stage for expanded utilization  of the test, which has the advantage of in-house expertise and resources.

“As an in-house assay, since we have access to additional clinical data and pathology information we can incorporate that into our interpretation. We’re providing an integrated interpretation of the patient’s molecular testing that some outside labs may not be able to offer. That’s beneficial for patients. For clinicians, it’s helpful to have in-house testing because they can reach out to our team with questions and discuss results with us directly,” Dr. Sun said.

CMS approval for GatewaySeq comes on the heels of another win for Washington University School of Medicine test developers. Earlier this year, ChromoSeq™-a molecular diagnostic test developed by Dr. Duncavage and team-became the first whole-genome sequencing test for cancer approved by the CMS. The test advances precision medicine approaches for treating blood cancers by identifying the full suite of genetic changes in a patient’s cancer cells, which provides crucial information that physicians can use to help determine the optimal treatment strategy for individual patients. ChromoSeq™ has been used in the past several years by Washington University oncologists to guide treatment decisions for patients at Barnes-Jewish Hospital and Siteman Cancer Centers with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). CMS approval for the test means physicians nationwide caring for patients with Medicare and commercial insurances diagnosed with AML or MDS will be able to order the test through Washington University Pathology Services.

“The development of a genetic assessment tool for solid tumors represents a major step forward in our efforts to provide the most complete and up-to-date information crucial in a precision approach to treating these cancers. The fact that this is the second CMS approval for reimbursement this year is a testament to the leadership of our department in developing tests that will specify the most precise treatments leading to the most optimal outcomes for our patients with cancer,” said Richard J. Cote, MD, FRCPath, FCAP, Edward Mallinckrodt Professor and Chair, Department of Pathology and Immunology.

The GatewaySeq team greatly appreciates the contributions of everyone involved in test development, including those from the Genomics Organization for Academic Laboratories (GOAL) consortium. The team is a proud member of GOAL, which drives the advancement of cutting-edge genomic testing at academic and non-profit laboratories by facilitating inter-institutional projects and data sharing.

Please see below for a full list of everyone at Washington University School of Medicine associated with GatewaySeq test development organized by affiliation. Congratulations to all:

Department of Pathology:

  • Lynn Coats, Business Director
  • Daisy Daleo, Manager of Clinical Support Office & Dermatopathology
  • Eric Duncavage, MD, Professor of Pathology and Immunology
  • Ryan Hardy, Manager of Application Programming & Development
  • Drew Hughes, MD, PhD, Assistant Professor of Pathology and Immunology
  • Ajay Khanna, Bioinformatics Scientist
  • Amanda Martsolf, Manager of Third-Party Reimbursement
  • Kelly Morgan, Manager of Coding Compliance
  • Mary Niedringhaus, Project Manager
  • Greg Robbins, Lead Developer
  • David Schoemehl, Developer
  • Laura Severs, MHA, MLS(ASCP)CM, Director of Clinical Operations
  • Lulu Sun, MD, PhD, Assistant Professor of Pathology and Immunology
  • Lauri Thienes, Senior Director of Clinical Operations
  • Jephne Wang, PhD, Manager of Clinical Genomics and Hematopathology

Department of Medicine:

  • David Spencer, MD, PhD, Associate Professor of Medicine

McDonnell Genome Institute:

  • Feiyu Du, Business & Tech Application Analyst, McDonnell Genome Institute
  • Shelly O’Laughlin, Director of Clinical Operations, McDonnell Genome Institute

Barnes-Jewish Hospital:

  • Phillip Foxwell, Supervisor of Surgical Pathology
  • Shilah Parrish, Assistant Director