On June 9, 2020 Veracyte, Inc. (Nasdaq: VCYT) reported its submission of a De Novo classification request to the U.S. Food & Drug Administration (FDA) for the nCounter Dx LymphMark Assay, a novel, genomic lymphoma subtyping test (Press release, Veracyte, JUN 9, 2020, View Source [SID1234560933]). The in vitro diagnostic test is used on the nCounter Flex Analysis System, Veracyte’s diagnostics platform, and is intended to add to Veracyte’s portfolio of tests that address complex clinical problems, helping to inform diagnoses and better treatment decisions.
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Veracyte has proposed the LymphMark test as an aid in disease characterization and prognosis to support disease management for patients newly diagnosed with diffuse large B-cell lymphoma (DLBCL). The LymphMark test utilizes gene-expression profiling of RNA extracted from formalin-fixed paraffin-embedded tissue to classify the "cell of origin" subtype of DLBCL tumors. The World Health Organization recommends gene-expression profiling for patients with DLBCL, given that certain subtypes are associated with poorer clinical outcomes, which may potentially be mitigated by more-specific treatments that are under development.1
"This submission marks an important milestone for Veracyte in our efforts to expand the menu of advanced genomic tests we provide on the nCounter system. Ultimately, our goal is to make our broader menu of tests accessible to patients worldwide through hospitals and laboratories that can perform them locally," said Bonnie Anderson, Veracyte’s chairman and chief executive officer.
Veracyte acquired the LymphMark test in December 2019 as part of its acquisition from NanoString of the exclusive global diagnostic rights to the nCounter system.
"DLBCL is an aggressive form of lymphoma with heterogeneous clinical behavior – outcomes significantly depend upon the distinct molecular subtype of each patient’s tumor," said Dr. David Scott, associate professor in the Department of Medicine at the University of British Columbia and a scientist in the Department of Lymphoid Cancer Research at BC Cancer, a program of the Provincial Health Services Authority. "The ability to determine this information from gene-expression profiling of tissue samples collected routinely in a clinical setting has the potential to transform patient care, making personalized treatment options more accessible."
Non-Hodgkin lymphoma ranks among the top-10 common cancers worldwide, with over 500,000 new cases estimated in 2018.2 DLBCL accounts for approximately 30 percent of lymphomas.3