Rapid, Near-Patient Tests to Monitor and Guide Therapy in Sickle Cell Disease Patients

Biomedomics, Inc., Resaerch Triangle Park NC

Investigators

Linked publications & trials

Abstract

? DESCRIPTION (provided by applicant): Rapid, Near-Patient Tests to Monitor and Guide Therapy in Sickle Cell Disease Patients The average life expectancy of a sickle cell disease (SCD) patient is 35 years of age in the developed world (National Center for Health Statistics), and significantly younger in the third world. The disease does not have a cure, but devastating complications such as stroke, acute renal failure, and acute chest syndrome can be controlled through therapies to improve patient survival and quality of life. Hydroxyurea and red blood cell (RBC) transfusion therapies are the two most common and effective treatments for SCD. As the only FDA- approved drug for SCD, hydroxyurea increases production of erythrocytes with higher levels of fetal hemoglobin (HbF) to interfere with the polymerization of sickle hemoglobin (HbS) and reduce sickling and vaso-occlusive events. Transfusions reduce the concentration of HbS in the patient through the introduction of fully functional hemoglobin (HbA) blood. Both therapies require the monitoring of HbF or HbS levels to allow the healthcare professional to make effective clinical decisions in dosing. Currently, Hb electrophoresis or high-performance liquid chromatography (HPLC) is used to monitor levels of Hb variants in patients during SCD therapy. The tests are high-cost (often over $100/test) and require significant turnaround time (often days). Biomedomics proposes to develop low-cost, rapid tests for the quantitative measurement of HbF and HbS in SCD patients receiving hydroxyurea and/or transfusion therapy. Using a lateral flow immunoassay platform, Biomedomics proposes the development of a test that can be manufactured for a little over $1 per cartridge. The proposed test platform is rapid, small-footprint, allowing for near-patient measurements of HbF or HbS levels within 15 minutes. In addition to reducing healthcare expenses, the proposed tests allow for immediate clinical decisions at the point-of-patient treatment. Biomedomics has developed proprietary antibodies for the measurement of Hb variants by immunoassay. Utilizing these antibodies and expertise in the field of point-of-care test development, Biomedomics proposes to (1) develop quantitative tests for measurement of HbF and HbS, (2) optimize tests to meet performance criteria to test clinical samples, and (3) deploy the tests in a clinical setting. These goals will be accomplished using a lateral flow sandwich immunoassay platform in conjunction with an inexpensive sampler module to treat and apply a small volume (5 µL) of blood sample. Fifteen minutes after sample addition, the test cartridge can be analyzed in a small, point-of-care reader. The proposed tests address an important need to enable the monitoring of SCD treatments near the patient to guide therapeutic decisions.