ILS has provided federal contracting support more than 30 years. We are qualified as a small business under NAICS codes 541711 and 541712, and our SAM.gov account information is continually updated. A list of some of our current contracts is provided below.
National Institute of Environmental Health Sciences (NIEHS)
Support Contract for the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods
This contract promotes the development, validation, acceptance, and use of alternative and revised testing methods and strategies that shall be more predictive of human health and ecological effects than currently available methods and strategies, while replacing, reducing, and refining animal use. This 10 year contract was renewed to ILS in 2015. ILS formerly held the contract for over 10 years.
Genetic Toxicity Testing Services for the NTP
ILS performs GLP-compliant genetic toxicity testing in rodents (rats and mice), cultured mammalian cells, and bacteria. Key testing capabilities that are utilized under this contract include the Ames test (bacterial gene mutation test), the in vivo rodent peripheral blood and bone marrow micronucleus tests, the in vivo rodent comet assay for assessment of DNA damage, and the Pig-a gene mutation assay in rodents. The in vivo rodent micronucleus and comet assays are of two types—those conducted on site and studies in which exposures are conducted at another laboratory and samples are collected and shipped to ILS for processing and analysis. In addition, in vitro micronucleus and comet assays are conducted using cultured human cells. All tests, including flow cytometry-based micronucleus and Pig-a assays, are conducted using internationally accepted protocols. In-house in vivo studies are conducted in ILS’ AAALAC-accredited facility. Data are electronically entered into the NTP’s Chemical Effects in Biological Systems (CEBS) database. ILS has been the incumbent contractor for over 20 years and during that time has developed/validated in vitro and in vivo genotoxicity, DNA repair, and mutagenicity tests.
Scientific Information Management and Literature-Based Evaluations for the NTP (subcontractor to ICF)
ILS is responsible for all phases of the preparation and production of the NIEHS/NTP Report on Carcinogens (RoC). The RoC is a congressionally mandated report that lists substances that are either known or reasonably anticipated to be human carcinogens as defined by criteria established by the NIEHS/NTP. The activities ILS staff conduct include: assisting the Office of the RoC in preparation of concept documents for substances to be considered for listing, delisting, or a change in listing status; writing monographs that review the publicly available data for candidate substances selected by NIEHS/NTP and incorporate the NTPs assessment of the information; planning, organizing and managing meeting details for expert panel reviews; supporting the development of profiles for new listings; updating information on the carcinogenicity, exposure, and related topics for existing chemical profiles; and preparing draft editions of the RoC that include profiles of chemicals listed in the previous editions plus new profiles and supporting information for chemicals being added to the new edition of the RoC.
Pathology Peer Review and Pathology Support for the Divisions of the National Toxicology Program (DNTP) and the Division of Intramural Research (DIR) at the National Institute of Environmental Health Sciences (NIEHS)
ILS provides necropsy, histology, histopathological interpretation, data acquisition into electronic format, gene expression, molecular pathology, immunohistochemistry, cell growth assays, and microarray pathology evaluation. ILS conducts Pathology Working Group reviews of pathology and toxicology data, target tissues, potential treatment-related lesions, and other selected tissues and lesions. ILS also provides support tasks for clinical research activities and data entry. The Pathology Support contract spans 10 years, and was renewed to ILS in 2015. ILS previously held this contract for 10 years.
Integration of Genomic Biomarkers with Human Embryonic Stem Cells Screening Assay (Phase II SBIR)
In utero exposure to environmental chemicals or drugs accounts for approximately 5% of all birth defects and can have an impact in adult life by disrupting the epigenetic developmental programs that are activated later in life (e.g., puberty, aging). Human embryonic stem (hES) cells reflect a unique biological system that cannot be represented by any other cell type used in toxicology. This project is focused on developing and validating a rapid toxicogenomics-based signature profiling assay in a human-relevant assay using the cell type at the origin of human development, the hES cell. We are developing a toxicogenomics-based signature profile built on the unique stem cell transcriptome response (protein coding mRNA and non-coding RNA), and cellular pathways responsive to toxicant exposures, using bioinformatics-driven computational methods. This will allow development of a biologically relevant signature profile based on dysfunction of the highly regulated genome and epigenome circuitry that maintains stem cell functions.
CometChip: Development of a High Throughput DNA Damage Assay in Hepatocytes (Phase II SBIR)
DNA damage can lead to mutations that can cause birth defects and cancer. The development of higher throughput chemical screening assays to assess the potential to damage DNA offers an effective strategy for improving public health. One of the key challenges lies in the fact that many types of DNA damaging compounds are benign unless they are biotransformed into reactive substances that primarily occurs in liver. The vast majority of currently used high throughput assays lack the enzymes needed for the biotransformation of xenobiotics to water soluble products and into highly reactive intermediates known to cause DNA damage. To overcome these limitations, we are utilizing a combination of scientific and engineering innovation to create a high throughput DNA damage assay using liver derived metabolically competent human cells (HepaRG™) and comet assay-based technology—the CometChip platform, a micro-fabricated micro-well system that automates much of the analysis—dramatically increasing both sensitivity and throughput. In Phase I of this project we established approaches that are effective for detecting DNA lesions in hepatocytes and demonstrated efficacy of high throughput screening by analyzing a small library of select compounds. In Phase 2, we are leveraging this technology to develop a general screening platform to detect DNA damage caused by agents from a variety of chemical classes. Results of the proposed studies will fill a critical gap in genotoxicity testing both nationally and internationally. Resulting technologies will enhance the efficacy of genotoxicity testing.
Assay Development for Measuring Chemical Effects on the Epigenome in Stem Cells (Phase II SBIR)
Pluripotency and stem cell differentiation processes are driven by networks of genes largely regulated by the epigenome. A biomarker panel capable of detecting a chemical’s potential to induce epigenetic effects on genes relevant to stem cell function could have utility for hazard identification. The objective of this project is to develop a medium throughput assay platform to monitor histone modifications at a panel of developmentally-relevant genes in human embryonic stem (hES) cells. A comprehensive toxicogenomics evaluation of gene expression changes will be performed using a training set of chemicals representing various classes of chemicals known to affect enzymes that modulate histone acetylation and methylation, including some known teratogens. Correlating changes in specific active and repressive histone marks at the promoters of consensus differentially expressed genes will then be identified to define a biomarker signature indicative of an “epigenetic response” in stem cells. The signature will be validated by blind testing a set of chemicals using an assay platform that allows for all chromatin immunoprecipitation steps to be performed in a single 96-well plate. This project will result in a medium throughput platform for rapid and efficient screening of effects of environmental toxicants on the human epigenome that could lead to developmental defects or predispose an individual to disease.
U.S. Food and Drug Administration (FDA)
Evaluation of the Allergenicity and Sensitization Potential of Fragrance Substances Based on Survey of Scientific Literature
ILS staff are conducting a survey of available literature and data on a list of fragrance ingredients for the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition, the center within FDA that regulates cosmetic products. The survey will be used to develop comprehensive, concise, and objective reviews of the available toxicological data, human health concerns, and other related information identified in the published literature and other available resources. Based on the scientific evidence detailed in these reviews, ILS will develop conclusions regarding the allergenicity and sensitization potential of the fragrance ingredients.
National Institutes of Health (NIH)
Genetic Toxicology Support (subcontractor to Southern Research)
ILS provides genetic toxicology testing services to support NDA submissions. Services provided include flow cytometry- and slide-based assessment of micronuclei induction in blood or bone marrow of rodents, chromosome aberration assays in human lymphocytes, and bacterial mutagenicity assays.