Esophageal Adenocarcinoma and Circulating Inflammation Markers

Contracting Office Address Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E134, Bethesda, MD 20892, UNITED STATES. Non-USPS mail such as Fedex, UPS and other private carriers please use Rockville, MD 20850. This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. N02CP82627-24 includes all applicable provisions and clauses in effect through FAR FAC 2005-99 (July 2018) simplified procedures for commercial items. Only one award will be made as a result of this solicitation. This will be awarded a firm fixed price order. The period of performance will be 12 months from the date of award of the contract. BACKGROUND Inflammation is a hallmark of cancer and cross-sectional data indicate that it is of key importance in esophageal adenocarcinogenesis. This is also reflected in the risk factor profile of esophageal adenocarcinoma which includes gastroesophageal reflux disease (GERD), obesity, and cigarette smoking. The direct mechanical effect of central obesity on esophageal adenocarcinoma 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 malignant transformation. 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 esophageal adenocarcinoma. Evidence is accumulating for an indirect inflammatory effect of central (visceral) adiposity in relation to the risk of esophageal adenocarcinoma. Mechanisms underlying the association between cigarette smoking and esophageal adenocarcinoma 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 on cancer risk is important so that we can have a clearer picture of pathogenesis providing knowledge for risk reduction strategies and highlighting molecular pathways for therapeutic intervention. There have been many case-control studies of inflammation-related biomarkers and esophageal adenocarcinoma risk, but interpreting this literature is difficult due to reverse causation as well as cancer treatment and survivorship factors. There have been few prospective studies of inflammation-related biomarkers in relation to esophageal adenocarcinoma, and none that have measured a broad array of biomarkers. This is in part due to the fact that esophageal adenocarcinoma is a rare malignancy and most cohort studies have accrued less than 50 cases. Therefore, to conduct a study with broad scope and sufficient statistical power, DCEG designed a nested case-control study using seven prospective cohorts within in the NCI Cohort Consortium to evaluate whether pre-diagnostic circulating biomarkers of inflammation, immunity and metabolism are associated with risk of esophageal adenocarcinoma. The results of this study are currently under review for publication. In summary, this prospective study provided evidence that indirect effects of excess adiposity and cigarette smoking, via systemic inflammation, increased the risk of esophageal adenocarcinoma. DCEG now wishes to conduct a replication and expansion study of these results from the initial discovery study. DCEG plans to assess biomarkers with strong and independent associations with esophageal adenocarcinoma and test whether these associations replicate in a distinct study population. DCEG will also assess other biomarkers, particularly those that are metabolically- or biologically-related to the initial findings. OBJECTIVE The primary objective of this project is to assess 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) by analyzing a total of 3 - l of serum per subject for a total of 564 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 adenocarcinoma, obesity and circulating markers of inflammation. SCOPE 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) by analyzing a total of 3 - l of serum per subject for a total of 564 subjects. The coefficients of variation are expected to be less than 10% for a majority (~90%) of markers assessed. The Contractor shall use the same assay platform and the same lots of any reagents/kits for all samples that could affect the assays. DCEG expects raw, filtered and normalized assay results to be provided in an accessible format such as .txt, .xlsx, or .csv within a period of 12 months of the award date. CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS (IF APPLICABLE) The Contractor shall: 1. 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) by analyzing a total of 3 - l of serum per subject for a total of 564 subjects. PLACE OF PERFORMANCE All work shall be performed at the Contractor's facility. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE All written draft and final deliverable products shall be submitted in electronic copy for review and comment by the Government's Contracting Officer Representative (COR) 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, with expected CVs of <10% for a majority (~90%) of markers. DELIVERABLE DELIVERABLE DESCRIPTION / FORMAT REQUIREMENTS DUE DATE 1 Raw, filtered and normalized quantitative assay results of 267 unique circulating biomarkers of inflammation on 564 serum samples in .txt, .csv, or .xlsx format 12 months after award PROVISIONS AND CLAUSES The following FAR provisions and clauses apply to this acquisition: FAR 52.212-3, Offeror Representations and Certifications - Commercial Items (November 2017) - with Addenda [Representation By Corporations Regarding an Unpaid Delinquent tax Liability or a Felony Conviction Under Any Federal Law and FAR 52.204-6, Unique Entity Identifier (October 2016)] FAR 52.212-4, Contract Terms and Conditions - Commercial Items (January 2017) FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (November 2017) FAR 52.237-3, Continuity of Services (Jan 1991) The Contractor shall comply with the FAR clauses in this paragraph that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items: FAR 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) FAR 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) FAR 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) FAR 52.219-8, Utilization of Small Business Concerns (Nov 2016) FAR 52.219-28, Post Award Small Business Program Representation (Jul 2013) FAR 52.222-3, Convict Labor (June 2003) FAR 52.222-21, Prohibition of Segregated Facilities (Apr 2015) FAR 52.222-26, Equal Opportunity (Sept 2016) FAR 52.222-35, Equal Opportunity for Veterans (Oct 2015) FAR 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) FAR 52.222-37, Employment Reports on Veterans (FEB 2016) FAR 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) FAR 52.222-54, Employment Eligibility Verification (OCT 2015) FAR 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) FAR 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) FAR 52.232-33, Payment by Electronic Funds Transfer System for Award Management (Jul 2013) Quotation Submission / Instructions FAR 52.212-1, Instructions to Offerors-Commercial Items (January 2017) FAR 52.212-2, Evaluation - Commercial Items (October 2014) BASIS FOR AWARD: Selection of an offeror for award will be based on an evaluation of proposals against four factors. The factors, in order of importance are: Technical Approach, Experience and Expertise of Staff, past performance and price. All evaluation factors other than cost or price, when combined, are significantly more important than cost or price. However, cost/price may become a critical factor in source selection in the event that two or more offerors are determined to be essentially equal following the evaluation of all factors other than cost/price. The process described in FAR 15.101-1 may be employed, which permits the Government to make tradeoffs among cost or price and non-cost factors to consider award to other than the lowest price offer or other than the highest technically rated factor. The Government intends to make an award to the offeror whose proposals provide the best overall value to the Government. The evaluation will be based on the demonstrated capabilities of the prospective Contractors in relation to the needs set forth in the Combined Synopsis/Solicitation. The merits of each proposal will be evaluated carefully. Each proposal must document the feasibility of successful implementation of the requirements of the Combined Synopsis/Solicitation. Offerors must submit information sufficient to evaluate their proposals based on the detailed factors listed below. The Evaluation Process: The Government will award a contract resulting from this quotation to the responsible Contractor whose quote conforming to the quotation will be the most advantageous to the Government, price and other factors considered. The following evaluation factors shall be used to evaluate the prospective contractors and are listed in order of importance. 1. Technical Approach (60) 2. Experience and Expertise of Staff (40) 3. Past Performance (Evaluated but not scored) 4. Price (Evaluated but not scored) 1. Technical and Management Approach (60 points) The Government has a need to quantitatively assess 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 a maximum of 3 - l of serum per subject for a total of 564 subjects. The potential Contractor shall be able to deliver a 4-7 week turnaround timeframe. Specific criteria that offerors will be evaluated on include: - A proven ability to accurately measure a minimum of 267 circulating biomarkers of inflammation (including the above specified markers) using 3 - l of serum per subject. This shall be determined by: o Published full-length manuscripts of conducted case-control or prospective cohort studies in peer-reviewed journals. o Transparent and fully-disclosed technology on a company website as well as in published full-length manuscripts in peer-reviewed journals. - A proven ability to conduct large scale projects (at least 500 subjects) in a timely manner. This shall be determined by: o Published full-length manuscripts of conducted case-control or prospective cohort studies in peer-reviewed journals. o Demonstrable evidence and testimony from prior customers that large (500+ subjects) projects can undergo individual quantitation of the 267 unique markers in less than a 7-week turnaround. This period of time includes past, and current, queues for assessment. - A proven ability to quantitate a majority (>90%) of the 267 circulating biomarkers of inflammation with high sensitivity and high specificity, indicated by overall (within and across batch/plate) coefficients of variation of less than 10% with independent verification by assessment of blinded samples for a study conducted by a group external to, and fully independent of, the offeror. - A proven ability to quantitate all of the specified (IL-17A, IL6, TNF-R2, VEGFR-3, IL-17RA, IL-6RA, RETN, TFF3, TNF, TNF-R1) circulating biomarkers of inflammation with high sensitivity and high specificity, indicated by overall (within and across batch/plate) coefficients of variation of less than 10%, with independent verification by assessment of blinded samples for a study conducted by a group external to, and fully independent of, the offeror. - Demonstrable evidence that large (500+ subjects) projects are managed effectively, efficiently, and without significant error. This includes: o Retaining specimens at -80'C pre- and post-quantitation. o The ability to return unused specimens in a frozen state with appropriate packaging and dry ice within 24 hours of being taken out of -80'C storage. o Having minimal requirements for hands-on time with the specimens that can increase errors in handling. o Having minimal requirements for aliquoting or transferring specimens that can increase errors in handling. o Having a logistics pipeline for receipt through to post-analysis of specimens that minimizes risk of errors or loss of integrity of the specimens. o Clear and timely communication throughout the project regarding status of the samples and project timeline. 2. Experience and Expertise of Staff (40 points) Offerors will be evaluated on the demonstrated experience, expertise, and successful history of assessing circulating inflammation markers. The Offeror's staff will be evaluated based on their ability to deliver the test results within the proposed timeframe and appropriate validity of quantitation. Specific criteria that offerors will be evaluated on include: - At least three senior staff in the biological sciences field and a summed total of at least 15 years' experience in laboratory sciences subsequent to attaining their doctorate, or equivalent, degrees. - Research staff who will conduct the assays must have at least 5 years' experience in laboratory research after, and not including, their highest degree attained. - Technical or research, peer-reviewed manuscripts authored by members of the offerors team using the technology proposed. Past Performance (Evaluated but not scored) Offerors shall submit the following information as part of their response: - A list of three (3) contracts providing similar services for quantitation of circulating inflammation markers currently in process that are similar in nature to the solicitation. Contracts listed may include those entered into by the Federal Government, agencies of state and local governments and commercial concerns. Include the following information for each contract or subcontract: 1. Name of Contracting Organization 2. Contract Number (for subcontracts, provide the prime contract number and the subcontract number) 3. Contract Type 4. Total Contract Value 5. Description of Requirement 6. Contracting Officer's Name and Telephone Number 7. Program Manager's Name and Telephone Number Each quoter/offeror may be evaluated on their performance under existing and prior contracts for similar products or services. The Government is not required to contact all references provided by the quoter/offeror. Also, references other than those identified by the quoter/offeror may be contacted by the Government to obtain additional information that will be used in the evaluation of the quoter/offeror's organizational experience. The Government may evaluate the offeror's past performance on organizational experience based on information obtained from references provided by the offeror, other relevant past performance on organizational experience information obtained from other sources known to the Government, and any information supplied by the offeror concerning problems encountered on the identified contracts and corrective action taken. The Government will assess the relative risks associated with each offeror. Performance risks are those associated with an offeror's likelihood of success in performing the acquisition requirements as indicated by that offeror's record of past performance. Additional Submission Instructions The quote must be prepared in two SEPARATE volumes: Volume I - "Technical Volume" and Volume II - "Price/Business Volume". Each of these parts shall be separate and complete in itself so that the evaluation of one may be accomplished independently of the evaluation of the other. The Request for Quotation (RFQ) number should be included on the front cover of each volume. Your quote must stipulate that it is predicated upon all the terms and conditions of this RFQ and signed by an official authorized to bind your organization. In addition, it must contain a statement to the effect that it is firm for a period of at least 60 days from the date of receipt thereof by the Government. This RFQ does not commit the Government to pay any of the costs associated with the preparation and submission of your quote. In addition, the Contracting Officer is the only individual authorized to legally commit the Government to the expenditure of public funds in connection with this requirement. By submitting a quote in response to this solicitation, it is understood that your quote shall become a part of the official contract file. Questions Questions relating to this acquisition shall be submitted to Contracting Officer, Kimesha Leake, via email at contact@example.gov no later than 5:00 PM EST on August 13, 2018. All email inquiries shall have "Question - Solicitation # N02CP82627-24" included in the subject line. Submission Deadline Quotes are due no later than 5:00 PM EST on Friday, August 16, 2018 to Contracting Officer, Kimesha Leake, via email at contact@example.gov. All quotation submissions shall have "Quotation - Solicitation # N02CP82627-24" included in the subject line. Evaluation and award will be conducted in accordance with the requirements of FAR 13.106. The Government does not anticipate requesting revisions to quotes, so Quoters should provide their best solution and price in response to the Solicitation. However, the Government reserves the right to request quote revisions that seek additional price discounts, provide revisions to the technical quote, or clarify aspects of the quote. In the event quote revisions are requested, the Government will not necessarily be seeking revisions from all Quoters. The technical volume must not contain references to price; however, resource information, such as data concerning labor hours and categories, materials, etc., must be contained in the technical volume so that the Respondent's understanding of the scope of work may be evaluated. Quoters must provide clear responses, including objectives and outcomes, to each task addressing the work to be performed in the SOW. The technical volume must reflect a clear understanding of the nature of the work being undertaken. Quotes which merely offer to conduct a project in accordance with the Government's requirements will not be eligible for award.