BIOFLUIDICA, INC. — Department of Health and Human Services SBIR Phase II: 102

Description

DESCRIPTION provided by applicant Multiple myeloma MM is a plasma cell malignancy and comprises about of malignant tumors and of all hematopoietic neoplasms According to the American Cancer Society in an estimated new cases were diagnosed in the U S with the estimated deaths being Monoclonal gammopathy of undetermined significance MGUS is associated with a per year risk of progression to overt malignancy most commonly MM and is found in approximately of individuals over with the prevalence increasing with age Without a clear diagnostic test to monitor MGUS malignancy progression a range of factors are currently monitored including changes in serum free light chains ratio elevated serum M protein level and high bone marrow plasma cell percentage Recent studies have demonstrated that circulating multiple myeloma cells CMMCs secured from bone marrow biopsies measured by immuno uorescence microscopy or ow cytometry are useful for diagnosis prognosis and measuring therapeutic response for MM However securing a bone marrow biopsy is painful to the patient prohibiting frequent testing required for monitoring disease progression drug response and or recurrence Development of novel instrumentation and techniques for CMMC selection and analysis directly from peripheral blood is essential to improve the management of patients with MM or its early disease stages Building on extensive preliminary data secured from a Phase I type study this Phase II project is focused on the development of an integrated system that uses a disposable fluidic cartridge and the associated instrument peripherals for the rapid and fully automated processing of CMMCs directly from whole blood obviating the need for bone marrow biopsies and thus allowing for more frequent testing especially those with MGUS The instrument will be able to select CMMCs at andgt recovery and andgt purity release the selected cells and electronically enumerate them and prepare them for FISH analysis or immunophenotyping The system can also off load the selected CMMCs for molecular profiling such as searching for KRAS mutations Operation of the instrument will be automated with an overall sample to answer processing time of h The system will be subjected to both internal validation by BioFluidica staff as well as external validation by collaborators at the University of North Carolina at Chapel Hill While MM will be used as a case study for clinical performance verification of the instrument it can easily be utilized in different cancer related diseases by programming in the correct selection antibody to search for the relevant blood borne biological cells PUBLIC HEALTH RELEVANCE Building on BioFluidicaandapos s Inc experiences for analyzing circulating tumor cells CTCs this project will generate an innovative system for the analysis of circulating multiple myeloma cells CMMCs directly from peripheral blood for all stages of the disease including the early monoclonal gammopathy of undetermined significance MGUS to symptomatic multiple myeloma The project outcome will be an automated system for the analysis of CMMCs including enumeration molecular profiling and fluorescence in situ hybridization with translation into clinical settings for securing data pertinent to future FDA clearance and or implementation in CLIA laboratories enabling oncologists to obtain valuable diagnostic information currently not available on multiple myeloma