BIOMEDOMICS, INC. — Department of Health and Human Services SBIR Phase I: NHLBI

Description

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 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 $ 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 $ per cartridge The proposed test platform is rapid small footprint allowing for near patient measurements of HbF or HbS levels within 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 develop quantitative tests for measurement of HbF and HbS optimize tests to meet performance criteria to test clinical samples and 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 L 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 PUBLIC HEALTH RELEVANCE A cure does not yet exist for sickle cell disease SCD but diagnosis and early intervention in the thousands of affected babies born each year improves survival and quality of life allowing patients to live into adulthood Patients in the developed world receive treatments such as hydroxyurea to raise levels of fetal hemoglobin HbF and transfusion to reduce levels of sickle hemoglobin HbS thus lowering the risk of stroke and other complications from SCD BioMedomics Inc proposes to develop and implement point of care tests for HbF and HbS to immediately assess guide and monitor therapies at the patient treatment site