Diagnovus Launches First Commercial Gene Expression Assay for Patients with Diffuse Large B-Cell Lymphoma

Diagnovus, LLC, a molecular diagnostic company focused on underserved, aggressive and lesser -known diseases, today announced the launch of ENGAUGE™‐cancer-DLBCL, the first commercial gene expression assay that can aid physicians in better risk stratification and treatment of patients with diffuse large B-cell lymphoma (DLBCL).

DLBCL is an aggressive tumor that can arise in virtually any part of the body. It is the most common sub- type of non-Hodgkin lymphoma, with an incidence of 7-8 cases per 100,000 people per year. Physicians currently assess a patient’s DLBCL risk of disease progression and outcome by using the International Prognostic Index (IPI), but more accurate classification of patients based on the underlying tumor biology is needed to allow physicians and patients to make more informed treatment decisions.

“ENGAUGE™‐cancer‐DLBCL, which combines a patient’s IPI score and the results of the gene expression assay, can more accurately predict outcomes for patients than IPI alone in order to optimize treatment choices for patients,” said Dr. Ron Levy, leader of the Lymphoma Program at Stanford University School of Medicine. “Traditional stratification schemes based on clinical characteristics such as the IPI have provided prognostic guidance in the management of patients with DLBCL. Despite the ease of use, IPI does not fully capture disease heterogeneity, and it is common to have two patients with identical IPI risk scores have very different outcomes.”

Dr. Izidore Lossos, University of Miami head of Lymphoma, said, “Application of better prognostic models at diagnosis will change the treatment of DLBCL patients, leading to more effective care. Knowledge of molecular prognostic markers may identify cellular mechanisms leading to the recognition of specific molecular targets for new therapeutic approaches.”

According to James Stover, Ph.D., vice president and co‐founder of Diagnovus, the company is committed to bringing personalized medicine to patients afflicted with these aggressive, underserved diseases by developing assays that assist physicians in achieving better outcomes for their patients. The ENGAUGE™‐cancer‐DLBCL assay is the first of a comprehensive line of molecular diagnostic tests for less frequent diseases.

“Using well‐studied genes incorporated into a multiplexed panel, ENGAUGE™ cancer-DLBCL has been developed from more than 10 years of research and exceeds the standard clinical characteristics that clinicians have used for prognosis for the last three decades,” Dr. Stover said. “Even more important is the fact that we can perform this assay in a reproducible and accurate manner using routinely available formalin‐fixed, paraffin‐embedded (FFPE) diagnostic biopsy tissue, unlike other genome-based assays that require special handling, such as snap freezing in liquid nitrogen.”