Serum Biomarker Study of Permethrin-Exposed Pesticide Applicators Using the Olink Immuno-Oncology Panel

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Rockville, MD 20850, UNITED STATES The National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), plans to procure, on a sole source basis, serum biomarker information from Olink Proteomics of 201 Dexter Avenue Watertown, MA 02472. This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1 (b)(2) and 13.501-(a)(1) using simplified acquisition procedures for commercial acquisitionist. The North American Industry Classification System code is 541380 and the business size standard is $15M. It has been determined there are no opportunities to acquire green products or services for this procurement. The most commonly used synthetic pyrethroid insecticide, permethrin, was first registered for agricultural use in the United States in 1979. Today, over two million pounds of permethrin are used annually in the United States for a range of applications, including agricultural and residential use. Permethrin metabolites are readily detected in the urine of the general population suggesting widespread exposure. Permethrin works by interfering with sodium channels of pests causing paralysis and eventually death. For mammals, it is believed that this mechanism is largely ineffective due to their ability to rapidly metabolize permethrin. However, the long-term health effects of permethrin exposure not associated with the nervous system remain a concern. In fact, the United States Environmental Protection Agency has classified permethrin as "likely to be carcinogenic to humans". In the Agricultural Health Study (AHS), a large prospective cohort that includes pesticide applicators in Iowa and North Carolina, exposure to permethrin has been associated with an increased risk of multiple myeloma. Multiple myeloma, an incurable hematologic cancer that affects plasma cells, is newly diagnosed in over 30,000 people annually in the United States. The biological mechanisms through which permethrin may influence the etiology of multiple myeloma remain poorly understood. DCEG proposes to investigate the biological plausibility and mechanisms of action underlying the observed association between permethrin and multiple myeloma in the study of Biomarkers of Exposure and Effect in Agriculture (BEEA), a molecular epidemiologic substudy comprised of over 1600 male pesticide applicators from Iowa and North Carolina actively enrolled in the AHS. Within BEEA, the DCEG investigation will focus on a subset of individuals for whom serial biological samples have been collected prior to and directly following applications of permethrin. The availability of samples from this recently exposed group (REG) allows DCEG to effectively investigate acute biologic effects that may elucidate the molecular mechanisms through which permethrin exposure could influence multiple myeloma development in pesticide applicators. Previous work has demonstrated the association of permethrin exposure with risk of multiple myeloma, however initial molecular events driving this association are unknown. The technology developed by Olink utilizing a Proximity Extension Assay allows users to simultaneously measure 92 analytes of interest in a single sample, while measuring 96 samples simultaneously on a single run reducing concerns of cross-batch drift in our results. This also greatly reduces sample consumption by only requiring a single microliter per sample. Additionally, Olink has developed a dual recognition system to diminish cross-reactivity issues that may occur with similar immunoassay formats. The immuno-oncology panel specifically contains biomarkers that have been shown to be associated with multiple myeloma directly relating to our study hypothesis. The results from this study will benefit the U.S. government and the public by providing new information about the etiology of multiple myeloma related to permethrin exposure, which is an important public health concern particularly for pesticide applicators. The immuno-oncology panel developed by Olink using proprietary Proximity Extension Assay technology was identified as the only assay capable of measuring the specific biomarkers required to pursue our research objectives with such a low volume requirement (1 - L per sample). Olink is the only source that can provide the necessary level of expertise to run this assay for DCEG's analytes of interest on DCEG's study samples with the limited volume that is available for analysis. This notice is not a request for competitive quotation. However, if any interested party, especially small business believes it can meet the above requirement, it may submit a proposal or quote for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 3:00 PM ET, on August 3, 2018. All responses and questions must be via email to Miguel Diaz, Contracting Officer at contact@example.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must be registered and have valid certification through SAM.GOV and have Representations and Certifications filled out. Reference: N02RC85021-45 on all correspondence.