Lead poisoning harms millions of people, yet is an entirely preventable health problem. The objective of this SBIR on "Point-of-Care Tests for Blood Lead Levels in Children" is to develop a significantly better blood lead test to identify and protect those at risk. Even at very low levels, ingested lead causes irreversible brain damage in developing children, resulting in decreased IQ, learning disabilities, attention deficit disorders, and behavioral problems. Because of these aspects of significantly decreased health and well being and increased education and healthcare costs, the U.S. Department of Health and Human Services has set an ambitious goal - the elimination of childhood lead poisoning through wide-spread screening. To aid in this effort, Alderon Biosciences proposes to develop a new, point-of-care test for determining blood lead levels that is cheaper, easier, faster, more sensitive, and uses smaller volumes. Alderon has the resources and expertise (laboratories, research scientists, engineers and commercial partners) to develop and commercialize the new product. The key innovations of our approach, proven feasible in Phase I and to be further developed in Phase II, will allow for accurate and highly sensitive point-of-care measurement of blood lead levels at lower cost, with smaller instruments and samples and without pre-test sample processing.
Four Specific Aims will guide our research on 'next generation'point-of-care tests to meet the need for improved blood lead testing.
Aim 1 research will develop new sensors and readers for more facile tests that eliminate the need for costly pre-test specimen preparation.
Aim 2 research will focus on test performance, aiming at 2 min tests, capable of measurements that have accuracy and precision equal to graphite furnace atomic absorption spectrometry (GFAAS) for blood lead levels ranging from 65 ug/dL down to 1.5 ug/dL.
Aim 3 research will show test utility at point-of-care for accurate, precise, and sensitive measurement of lead in clinical blood specimens. Building on these results, in Aim 4 we will fabricate the prototype test system and prepare a comprehensive report, technical specifications and plans to be used for guiding manufacture and clinical trials in Phase III commercialization of the product. Accomplishment of the four Specific Aims will thus set the stage for commercialization of a new 'next generation'product for blood lead testing that can deliver results that identify and protect children at risk at lower cost and with unprecedented simplicity. High project significance and impact lies in the lower cost and simplicity of the tests, which would extend testing into more resource poor settings in the U.S. and around the world, provide doctors with immediate knowledge of poisoned children, minimize loss of children whose parents do not return for followup, and aid in discovery and elimination of environmental lead sources that poison children.

Public Health Relevance

Lead poisoning threatens and harms millions of children, yet is entirely preventable. More sensitive, facile and lower-cost blood lead tests are needed to extend testing to resource-poor settings and to help identify lead- poisoned children for remedial action. Alderon Biosciences proposes to meet this need by developing sensors and readers for use at point-of-care that can support rapid and low-cost ASV determinations of blood lead levels without any pre-test sample processing and by validating the utility of this next generation blood lead testing product.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HD077971-02
Application #
8777702
Study Section
Special Emphasis Panel (ZRG1-IMST-M (13))
Program Officer
Urv, Tiina K
Project Start
2013-09-05
Project End
2016-07-31
Budget Start
2014-08-15
Budget End
2015-07-31
Support Year
2
Fiscal Year
2014
Total Cost
$453,545
Indirect Cost
Name
Alderon Biosciences, Inc.
Department
Type
DUNS #
137313813
City
Beaufort
State
NC
Country
United States
Zip Code
28516