HHS SBIR RFA-ES-14-005

Traditional exposure assessment has relied on the use of questionnaires, ambient monitoring of pollutants and limited personal exposure assessments for individual analytes in biomonitoring efforts. These approaches have identified many potential contributing factors but are known to suffer from limitations in misclassification due to spatial and temporal distribution of analytes, imprecision of the methods or failure to account for multiple covariate analytes or mixed routes of exposure.  For these reasons biomonitoring for chemicals and their metabolites, nutrition factors, and even chemical threat agents has become a primary factor in establishing the link between exposure and disease in human population studies. Through the National Biomonitoring Program (NBP) and The National Health and Nutrition Examination Survey (NHANES), the CDC has established gold standard methods to measure over 450 chemicals and nutritional markers in blood, serum, urine, breast milk and meconium. These include measuring toxic metals, phthalates, persistent organic pollutants, pesticides, vitamins and other micronutrients and tobacco smoke markers, including cotinine and NNAL, using a variety of mass spectrometry approaches. Although the NBP currently conducts biomonitoring analyses for state health departments and NIH-funded studies, including the National Children’s Study, capacity for analyzing biospecimens from other human population studies is limited. Traditional biomonitoring programs such as the CDC's often require large sample volume, especially for blood and serum analysis, making it impractical for many population studies where very small volumes of blood are collected for genetic or other analyses.  There is therefore an urgent need for technology development for biomonitoring capabilities to complement and expand the CDC’s efforts.

NIEHS and other NIH Institutes have supported a limited number of projects through the SBIR/STTR programs for biomonitoring technologies that use Raman spectroscopy, XRF technology, or antibody or aptamer-based approaches. However, a larger program is needed to develop point-of-use, field-deployable or laboratory-based methods that:

• Use small sample volumes, especially for blood
• Can measure multiple analytes or classes of compounds simultaneously in blood, serum, urine, saliva, breast milk, meconium, hair or toenails
• Are resistant to fouling or effects from interferents
• Are relatively low-cost, rapid and amenable to use in multiple laboratories
• Can measure chemicals or their metabolites at the level of ambient exposures with appropriate  limits of detection and specificity

Technologies should be developed to measure chemicals or functionally related compounds that include, but are not limited to, toxic metals, endocrine-active compounds, air pollution components (e.g., PAHs), persistent organic pollutants, pesticides, endogenous hormones, flame retardants, and chemical threat agents. Technologies that detect multiple toxins produced by pathogenic organisms, including dust mite or pet allergens, endotoxin, and mycotoxins are appropriate for this FOA; however, technologies to detect the pathogenic organisms themselves are not responsive.  Modular approaches that can be used to apply a single analytical technique to a range of possible chemical classes are encouraged.  For instance, a group may focus on a technology to detect all commercially-produced pesticides and their metabolites in one platform, a large set of known or suspected endocrine-disrupting compounds in a second, and genotoxic compounds in a third.  These ‘chips’ could then be selectively used by investigators to characterize the levels of some or all of these analytes in their study. Approaches that combine detection of individual analytes together with functional assays are also encouraged, but not required. For example, a technology may detect individual estrogen-active compounds along with a measure of overall estrogenic activity in that sample.

The long-term goal of this effort is to enable rapid, sensitive and low-cost detection of large sets of analytes reflecting the complexity of exposure in the personal environment, i.e., the "exposome" concept. Such technologies will be valuable not only to individual researchers in the field of environmental epidemiology and public health, but to Federal agencies, State and Local institutions including emergency responders, and to community-based efforts to understand exposures in susceptible populations.

This FOA supports development of technologies for detection of multiple analytes. Applications for biomonitoring technology for single analyte detection are not responsive.