New Test Offering - MRD-CLL

Hematogenix

Hematogenix® Laboratory Services - an industry leader in the field of integrated pathology services for drug development and immuno-oncology testing, launches monitoring of minimal residual disease (MRD) for Chronic Lymphocytic Leukemia (CLL). Achieving MRD-negative complete remission (CR) is a prerequisite for long-term unmaintained disease-free survival. The use of MRD analysis in CLL is becoming increasingly common for assessment of response, identifying the process of tumor depletion and relapse, and it is proposed as a potential surrogate endpoint in clinical trials. Hematogenix® has validated a flow cytometry-based MRD test, which is a standardized method that has been established by the European Research Initiative on CLL (ERIC). This test is performed on peripheral blood and bone marrow aspirate samples and has a sensitivity of 10-4 or 0.01%.

According to the American Cancer Society, in 2018 it is estimated that there will be more than 20,000 new cases of CLL, representing 1.2% of all new cancer cases in the U.S., and an estimated 4,510 people will die of this disease. Various treatment and therapeutic options now exist for CLL. The goal of therapy is to reach longer progression-free survival (PFS) and overall survival (OS). The National Comprehensive Cancer Network® (NCCN) guidelines state that MRD negativity, determined in the peripheral blood after the end of treatment, is emerging as an important predictor of treatment efficacy. The NCCN guidelines suggest the testing used to evaluate MRD has a sensitivity of 10-4 or 0.01%; this level of sensitivity is accomplished by the Hematogenix® MRD-CLL assay utilizing the standardized ERIC method.

Hytham Al-Masri, MD, CEO, and founder of Hematogenix®, commented that “our MRD-CLL assay using the standardized ERIC protocol improves prediction of progression-free survival (PFS). Our assay will help our Pharma partners by providing a surrogate marker for longer PFS in their clinical studies potentially shortening the time to assess the efficacy of their new drugs in development. The potential clinical utility of a highly sensitive assay to detect MRD can be used to direct individualized therapy and will be beneficial to oncologists and their patients.”