ALDERON BIOSCIENCES, INC. — Department of Health and Human Services SBIR Phase II: NICHD

Description

DESCRIPTION provided by applicant Lead exposure threatens the health of millions of children yet it is entirely preventable health problem Our project objective is to develop an advanced blood lead test to identify and protect those at risk through blood lead screening tests of children Even very low lead exposure measured by blood lead levels causes irreversible damage especially in very young children resulting in decreased IQ learning disabilities attention deficit disorders behavioral problems stunted growth and other serious individual and societal problems The US Department of Health and Human Services has established an ambitious goal of eliminating lead poisoning in children The Centers for Disease Control has lowered the level of blood lead that calls for concern down to g dL with predictions of settin a lower level of concern in the near future It is generally agreed that no level of lead exposure s safe To aid in this public health effort we propose to develop a new needed clinical blood lead test The Aims of our Phase II research and development project are to produce and validate a low cost diagnostic product by Aim developing an innovative sensor platform capable of sensor based measurement of blood lead levels by Aim developing the platform to meet current and emerging needs of accuracy and precision over the entire range of measurement for child tests down to blood lead levels of g dL using a single drop of blood by Aim producing a new proprietary Metexchange r reagent containing no toxic chemicals that effectively lyse RBC and releases Pb for sensitive and accurate ASV analysis of blood lead levels over the entire clinical range without bias to Graphite Furnace Atomic Absorption Spectroscopy GFAAS and by Aim validating accurate precise and sensitive measurements of total lead levels in clinical blood specimens over the entire range equal to or better than GFAAS No system yet accomplishes this PUBLIC HEALTH RELEVANCE Lead exposure threatens and harms millions of children yet it is an entirely preventable public health problem In children even very low levels of blood lead are associated with lowered IQ and attention de cit disorder and can lead to juvenile delinquency and criminal behavior More sensitive facile and lower cost blood lead tests are needed for screening children in resource poor settings The goal is to identify lead levels in children for medical and environmental remedial action To meet this need Alderon Biosciences is developing a andquot next generationandquot low cost blood lead test system for early diagnosis of childhood lead poisoning