The Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E124, Rockville, MD 20850, United States.

2.0 DESCRIPTION

The U.S. Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB) intends to procure, on a sole source basis, services for the assessment of 267 unique circulating biomarkers from Olink Proteomics AB, Dag Hammarskjolds Vag 52B, Uppsala, Sweden.

The response close date of the notice for this requirement is in accordance with FAR 5.203(b). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and will be made pursuant to the authority in FAR Part 13.106-1(b)(1); and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541380 and the business size standard is $15M.

The period of performance shall be for one (1) 12-month base period from the date of award.

The anticipated award shall be firm fixed price for severable services.

It has been determined there are no opportunities to acquire green products or services for this procurement.

3.0 BACKGROUND

Inflammation is a hallmark of cancer, and cross-sectional data indicate that it is of key importance in the development of esophageal adenocarcinoma and its precursor metaplasia, Barrett's esophagus. This is also reflected in the risk factor profile of Barrett's esophagus which includes gastroesophageal reflux disease (GERD), obesity, and cigarette smoking. The direct mechanical effect of central obesity on Barrett's esophagus risk is widely accepted; central adiposity amplifies intra-gastric pressure and disturbs normal sphincter function, culminating in a higher propensity for GERD and subsequent increased risk of developing Barrett's esophagus. While GERD is understood to have direct carcinogenic effects on esophageal mucosa, it is unknown whether systemic inflammation may partly explain associations of obesity and smoking with this malignant process. Evidence is accumulating for an indirect inflammatory effect of central (visceral) adiposity in relation to the risk of Barrett's esophagus and esophageal adenocarcinoma. Underlying mechanisms of these associations possibly include genotoxic effects, promotion of GERD, and promotion of systemic inflammation and immune dysfunction. Elucidating whether systemic inflammation is a mechanism that underlies these exposures is important so that the Metabolic Epidemiology Branch (MEB) can have a clearer picture of pathogenesis providing knowledge for risk reduction strategies and highlighting molecular pathways for therapeutic intervention.

4.0 OBJECTIVE

The U.S. Department of Health and Human Services, National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG), Metabolic Epidemiology Branch (MEB) requires the assessment of 267 unique circulating biomarkers of inflammation including the high priority markers of interleukin-17A (IL-17A), interleukin-6 (IL6), tumor necrosis factor receptor 2 (TNF-R2), vascular endothelial growth factor receptor 3 (VEGFR-3), interleukin-17 receptor A (IL-17RA), interleukin-6 receptor subunit alpha (IL-6RA), resistin (RETN), trefoil factor 3 (TFF3), tumor necrosis factor (TNF), and tumor necrosis factor receptor 1 (TNF-R1) using 3 ul of serum per subject for a total of 100 subjects. The assay needs to be highly reproducible with low coefficients of variation. DCEG expects this study to further unravel the complex relationships between esophageal adenocarcinogenesis, obesity and circulating markers of inflammation.

The key purpose of this acquisition is to further unravel the complex relationships between esophageal adenocarcinogenesis, obesity, and circulating markers of inflammation. To date, there have been few prospective studies of inflammation-related biomarkers in relation to this malignancy, and none that have measured a broad array of biomarkers. This is in part due to the fact that Barrett's esophagus and esophageal adenocarcinoma are rare in the population. Elucidating whether systemic inflammation is a mechanism that underlies these exposures is important so that the MEB can have a clearer picture of pathogenesis providing knowledge for risk reduction strategies and highlighting molecular pathways for therapeutic intervention.

5.0 CONTRACTOR REQUIREMENTS

The Contractor shall:

Quantitate a total of 267 unique circulating biomarkers of inflammation including the high priority markers of interleukin-17A (IL-17A), interleukin-6 (IL6), tumor necrosis factor receptor 2 (TNF-R2), vascular endothelial growth factor receptor 3 (VEGFR-3), interleukin-17 receptor A (IL-17RA), interleukin-6 receptor subunit alpha (IL-6RA), resistin (RETN), trefoil factor 3 (TFF3), tumor necrosis factor (TNF), and tumor necrosis factor receptor 1 (TNF-R1) using 3 ul of serum per subject for a total of 100 subjects with coefficients of variation (CV) of <10% for a majority (~90%) of markers assessed. The Contractor shall use the same assay platform and the same lots of any reagents/kits etc. for all samples that could affect the assays. The Contractor shall provide raw, filtered and normalized assay results in an accessible format such as .txt, .xlsx, or .csv within ten (10) months after award.

6.0 PLACE OF PERFORMANCE

All work shall be performed at the Contractor's facility.

7.0 REPORT(S)/DELIVERABLES

All written drafts and final deliverable products for the quantitative results of 267 unique circulating biomarkers shall be submitted electronically in a .txt, .csv, or .xlsx format ten (10) months after award for review and comment by the Government's technical point of contact (COR) (TBD at award) for a review period not to exceed thirty (30) days. Final copies of approved drafts shall be delivered to the COR within ten (10) business days after receipt of the Government's comments. The criteria for acceptance include high quality data and outputs, specifically coefficients of variation (CV) of <10% for a majority (~90%) of markers assessed, as stated within the requirements section above.

8.0 UNIQUE QUALIFICATIONS OF THE CONTRACTOR

No other platform or Contractor is known that is able to reproducibly quantitate the high number of markers (including the set of high-priority markers) using such a small amount of specimen (3 ul serum per subject).
The high level of multiplexing while maintaining high reproducibility is due to the proprietary Proximity Extension Assay (PEA) technology of Olink that measures 92 proteins simultaneously using only one microliter of serum, plasma, or almost any other type of biological sample. Each biomarker is addressed by a matched pair of antibodies, coupled to unique, partially complementary oligonucleotides, and measured by quantitative real-time PCR. This dual recognition, DNA-coupled method provides exceptional readout specificity, since unlike in many other immunoassay formats, any antibody cross-reactivity that may occur during the multiplexed assay is excluded from the detection process.

Accurate quantitation of 267 biomarkers of inflammation captures a broad scope of putative inflammation processes that may be contributing to cancer development. This enables a more robust interrogation of biologic pathways that may have essential functions in loss of regular cell division and in the formation of a tumor. Being able to assess 267 biomarkers using just 3 ul serum is extremely important because this serum is extremely valuable when available from cohorts that have collected it many years before cancer development, especially given the rarity of being diagnosed with Barrett's esophagus or esophageal adenocarcinoma.

In fiscal year 2018, Olink Proteomics assessed the same 267 inflammation biomarkers for esophageal adenocarcinoma cases and controls. The current requirement to assess these biomarkers in Barrett's esophagus (the precursor to esophageal adenocarcinoma) as well as a control set, would enable value-added analyses across the two sets of patients that represent stages of cancer development. Given that quantitation of proteins varies by platform and technology, a change in Contractor would provide results that are not scientifically comparable to previous findings, thus being disruptive to the overall body of research.

This notice is not a request for competitive quotations. However, if any interested party, especially a 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 enough detail to allow NCI to determine if the party can perform the requirement. All responses and questions must be submitted via email to Adam Hernandez, Contract Specialist at [email protected]. Responses are due no later than 3:00 P.M. EST on Tuesday, June 18, 2019 (06/18/2019). 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 determining whether to conduct a competitive procurement. To receive an award, Contractors must be registered and have valid certification in the System for Award Management (SAM) through SAM.gov, and have Representations and Certifications filled out.

Reference: 75N91019Q00077 on all correspondence.