BioFluidica, Inc. has released the clinical data for minimal residual disease detection in Acute Myeloid Leukemia (AML) patients using circulating leukemic cells selected from blood. The data was published in the peer reviewed journal the Analyst (141 (2016) 640). AML is a rapidly developing leukemic disease with ~20,000 cases reported in 2015 with a 5-year survival rate of only 25%.
The goal of this study was to detect early stages of disease relapse following stem cell transplantation. Currently AML relapse is detected using bone marrow biopsy samples that are painful for the patient and using existing commercial tests, limits the frequency of testing and thus resulting in poor outcomes for AML patients. The paper describes that using BioFluidica’s analytical technology relapse could be detected nearly 2 months earlier than conventional tests. In addition, test frequency could be significantly increased using BioFluidica’s technology compared to tests requiring bone marrow biopsies.
Professor Steven A. Soper, the scientific founder of BioFluidica and co-author of the paper with Dr. Paul Armistead, a hematologist, both at the University of North Carolina states that “the use of a blood test compared to a bone marrow biopsy would be a tremendous advancement in diagnostic capability that can dramatically improve the survival rate of patients with AML.”
BioFluidica is developing innovative technologies for the isolation and analysis of rare, circulating biomarkers in the blood. The company’s first platform has the capacity to isolate circulating tumor cells, exosomes and cfDNA from the blood with unprecedented recovery and purity. The technology is based on patented microfluidics designs which has been clinically validated for 6 different cancer types including Colorectal, Pancreatic Ductal Adenocarcinoma, Ovarian, Breast, Multiple Myeloma and AML. Additionally, stroke detection and infectious disease identification have also obtained clinical validation using the BioFluidica test. The company was cofounded by Dr. Soper who is currently a Professor in Biomedical Engineering and Chemistry at the University of North Carolina at Chapel Hill (UNC-CH). He is also Director of a new center on the UNC-CH campus, Center for BioModular Multi-scale Systems for Precision Medicine, focused on developing new tools for the molecular analysis of circulating biomarkers.
