Patterns of microRNA expression to identify B cell malignancies

Value Proposition

Malignancies derived from mature B cells are common and constitute the majority of leukemias and lymphomas and reflect defined stages of normal B-cell differentiation. Correct diagnosis of B cell malignancies is important from both a clinical standpoint and from the standpoint of setting appropriate patient expectations. A misdiagnosed B cell malignancy may lead to an inappropriate therapy, which can unnecessarily endanger the patient's life and/or be an ineffective treatment for the B cell malignancy. As an example, the difficulty and importance of obtaining the correct diagnosis in Burkitt lymphoma was highlighted by the experience of a multicenter clinical trial, CALGB trial#925119, in which nearly half of the 100 patients with an assigned diagnosis of BL were found to have another diagnosis upon further pathology review. If diagnosed and treated appropriately, nearly 80% of patients with BL can be cured with intensive (high dose) chemotherapy regimens. Thus, a misclassification of BL as diffuse large B cell lymphoma (DLBCL) can result in a missed opportunity to cure the malignancy. On the other hand, misclassification of DLBCL as BL leads to unnecessarily morbidity from intensive chemotherapy regimens. Thus, methods that improve the diagnosis of BL, and other B cell malignancies, can provide better outcomes in patients.


Duke researchers have reported biomarkers for identifying a B cell malignancy that can be used to accurately diagnose patients. This invention uses microRNAs, a novel class of biomarkers that provide new opportunities for clinical translation. Intact microRNAs can be isolated from tissues preserved using standard methods, such as formalin fixed, paraffin embedded (FFPE) tissue. Thus, microRNA-based biomarkers could be easy to translate to clinical use. Additionally, microRNAs can be readily assayed using real-time PCR and other methods available in conventional pathology. Expression of these lineage-specific microRNAs could correctly predict the lineage of B-cell malignancies in more than 95% of the cases.


  • Can help correctly diagnose B cell malignancies, offering a method to identify patients for clinical trials
  • Uses microRNA-based biomarkers that can be easily translated to clinical use
  • Demonstrated strong potential in diagnosing chronic lymphocytic leukemia, follicular lymphoma, Hodgkin’s lymphoma, activated B-cell diffuse large B cell lymphoma, germinal center-like DLBCL, and Burkitt lymphoma
Diffuse large B-cell lymphoma of the small intestine

Duke File (IDF) Number



  • Dave, Sandeep
  • Jacobs, Cassandra


    • Patent Number: 10,047,400
    • Country: United States of America

For more information please contact


School of Medicine (SOM)