Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Bethesda, MD 20892, UNITED STATES

Description
The National Cancer Institute (NCI), Division of Cancer Epidemiology (DCEG), Epidemiology and Biostatistics Program (EBP), Infections and Immunoepidemiology Branch (IIB) plans to procure on a sole source basis Inflammation Analysis and Sample Preparation from Olink Proteomics, 65 Grove Street, Watertown MA 02472.

This acquisition will be processed in accordance with the simplified acquisition procedures as authorized by FAR Part 13.106-1 (b) (1) using simplified acquisition procedures for commercial acquisitions and prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. The North American Industry Classification System Code is 541380 and the business size standard is $15.0 million.

Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract.

The period of performance shall be 12 months from date of award.

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

BACKGROUND

Gallbladder cancer is a rare, but highly fatal cancer often diagnosed in late stages with an overall median survival rate of 3-7 months. Because early stage tumors can be cured with cholecystectomy, early detection is critical to increase survival. The prevalence of gallstones, the major risk factor for gallbladder cancer, is highest among Amerindian women. In the US, the prevalence is >60% among women with Amerindian ancestry, in contrast to 9% among non-Hispanic white women. Gallstones cause a constant inflammatory state, releasing inflammatory mediators, such as cytokines, chemokines, and prostaglandins, into the microenvironment. The sustained release of cytokines can lead to activation of oncogenes and inactivation of tumor suppressor genes, resulting in carcinogenesis. Latinos with Native American ancestry are more likely to develop gallstones earlier in life and more likely to have multiple gallstones (instead of single stones) than other ethnicities, resulting in prolonged chronic inflammation. Thus, evaluating inflammatory profiles in Amerindians may identify biomarkers that could be used for cancer prevention. To evaluate this question, the NCI will use baseline data from the Chile Biliary Longitudinal Study (Chile BiLS), women aged 50-74 with gallstones living in Chile. In this cohort, we can measure circulating inflammation proteins among Chileans of Mapuche ancestry (the major Amerindian tribe in Chile) compared to non-Mapuche Chileans.

Study Objectives: The NCI hypothesizes that circulating inflammation proteins will differ between women with and without Amerindian ancestry. Specifically, the NCI will assess:

1. The differences in inflammatory response between Mapuche and non-Mapuche women with regards to 4 inflammation markers previously associated with gallbladder cancer development and survival: CCL20, CXCL8, CXCL10, IL-6.

2. The differences in inflammatory response between Mapuche and non-Mapuche women with regards to all available inflammation markers from the Olink Inflammation panel.

Study Approach: The NCI will randomly select 200 self-reported Mapuche and 200 self-reported non-Mapuche women from this cohort and measure circulating immune related markers in serum collected at baseline. Approximately 25% of the cohort self-identifies as Mapuche. Preliminary data from Chile suggest good correlation between self-reported Mapuche and Native American ancestry. Women with European or Latino/Chilean ethnicity will be selected for the non-Mapuche comparison group. The NCI will ship 400 samples to the Contractor. The Contractor shall aliquoted these samples into 420 samples including 20 quality control samples (QCs). The Contractor shall test these 420 serum samples from these cohorts including the quality control samples (QCs) using an inflammation panel (N=92 markers).

OBJECTIVE

The NCI would like to aliquot (sample preparation) 420 serum samples. In addition, NCI plans to test these 420 aliquots using an inflammation panel (N=92 markers).

SCOPE

The Contractor shall test up to 420 samples using the Olink inflammation panel (N=92 markers) and aliquot (sample preparation) 420 serum samples. The inflammation panel was designed in close collaboration with experts in inflammation-related diseases and includes a number of cytokines, chemokines, and other inflammation markers related to cancer.

CONTRACTOR REQUIREMENTS

The Contractor shall perform the following task:

Task 1. Aliquot 420 (sample preparation) serum samples.

Task 2. Inflammation analysis of these 420 serum samples (N=92 markers) and delivery of test results.

The total amount of samples that NCI will ship to Olink for testing is 400.

Residual samples will be returned to NCI. The NCI will arrange shipment of these samples to and from the Contractor. Delivery of test results will be in an electronic encrypted file.

QUALITY ASSURANCE

Contractor Quality Requirements

Tests - Contractor shall use existing knowledge of acceptable libraries and sequencing output to verify that quality is maintained.

Supervision - This should be limited to avoid employee/employer relationships.
There is no potential conflict of interest on this point.

Review Requirements - None.

PLACE OF PERFORMANCE

At the Contractor's Facility.

REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE
Task 1. Aliquot 420 serum samples to NCI TPC (Technical Point of Contact.) Within 6 months after award is issued.
Task 2.
Inflammation analysis (N=92 markers) and delivery of test results: number of samples 420 to NCI TPC.

Within 8 months after award is issued.

Olink Proteomics has an inflammation panel that was designed in close collaboration with experts in inflammation-related diseases and includes a number of cytokines, chemokines, and other inflammation markers related to cancer. The cardiometabolic panel includes the most liver-specific proteins and proteins that have been associated with liver diseases based on databases like DisGeNET. In addition, a previous procurement was issued by Olink and in order to prevent a variation in results, Olink is the only known vendor that can continue to complete the specified work.

This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities 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 5:00 PM EST, on
February 5, 2019. All responses and questions can be emailed to Kimesha Leake, Contracting Officer via electronic mail at [email protected]. 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 in the System for Award Management (SAM) through sam.gov. Reference: 75N91019Q00011 on all correspondence.