Contact Points
Boulder, CO, 80301-2255, United States
This notice of proposed acquisition is posted as an intent to award a firm-fixed price service contract on a non-competitive basis to Somalogic, Inc. for SomaScan Discovery, which is the Proteomic Assessment of Dietary Restriction in Non-Human Primate Plasma. Previous discovery-based proteomics projects within the National Institute on Aging have been completed internally using mass-spectrometry based methods. Currently, TGB wishes to assay approximately 7,000 proteins using approximately 130 microliters of plasma per sample. While this is not possible using previously employed mass-spectrometry based methods, this can be done using the SomaScan assay developed by SomaLogic.
The essential characteristics of the SomaLogic SomaScan Disvoery that limit the availability to a sole source are proprietary proteomic assay is based on individual SOMAmer reagents: synthetic protein affinity reagents purposefully selected in vitro by the SELEX process under the assay conditions in which they are to be used. This SELEX approach allows for fine control of the reagents, optimizing their binding properties specifically for the downstream assay, thereby generating high affinity reagents geared specifically towards sensitivity, specificity, multiplexing, and detection in the SomaScan® assay. This is in contrast to antibody generation in animals where conditions cannot be modified to tailor-make antibodies for assay conditions. Additionally, after SELEX, the SOMAmer reagents are synthesized by well-established DNA synthesis techniques allowing for a more uniform and consistent reagent.
The SomaScan assay has been deployed for the discovery of biomarkers in biospecimens that are transferred to SomaLogic, Inc. laboratories. The nearly 7,000 targets in the assay represent proteins including cytokines, growth factors, receptors, proteases, protease inhibitors, kinases, structural proteins, and hormones known to be important in human diseases.
The SomaScan assay is performed under the control of the SomaLogic Quality System (QS) in a laboratory that is CLIA accredited. The assay consumes only 100 μL of plasma or serum (although we ask collaborators to provide 150 μL so there is enough for two runs), and hundreds of assays can be run in parallel in 96-well plates. Assay qualification studies show that the assay performs with median sensitivity of 100 fM (limit of detection) and median coefficient of variation (CV) of approximately 5% across all analytes measured repeatedly in replicate runs of plasma samples. In addition, the overall detection range of the platform spans 10 logs in plasma or serum.
This acquisition is being conducted under Federal Acquisition Regulations (FAR) Part 13 – Simplified Acquisition Procedures, and FAR Part 12—Acquisition of Commercial Items, and the resultant contract award will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2023-04 dated June 2, 2023.
The purpose of this acquisition is to procure services for the SomaScan Discovery delivering v4.1 7k protein measurements from other matrices in three dilutions with plasma diluent. The National Institute on Aging (NIA) Translational Gerontology Branch (TGB) require proteomic assessment of dietary restriction in non-human primates for ongoing research studies. Individual responses to different dietary restriction paradigms can be highly variable between individuals and is not well understood. Easily accessed blood biomarkers that predict individuals that will have favorable or detrimental responses to these interventions would have a great clinical utility for tailoring treatments for individuals. Therefore, it is critical to identify proteomic biomarkers that predict and evaluate response to diet. Previous studies have examined responses to dietary restriction paradigms in non-human primates as well as the effects on health outcomes and the microbiome . The aim is to utilize a proteomic platform to identify signatures that can predict health and microbiome responses to calories restriction interventions in non-human primate plasma samples collected from a completed study in the translational gerontology branch. This will provide new insight into molecular signatures of dietary responses and outcomes.
SCOPE OF WORK
GENERAL REQUIREMENTS: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:
SPECIFIC REQUIREMENTS:
- The Contractor shall perform discovery-based proteomic assays on approximately 37 non-human primate samples from the translational gerontology branch cohort to identify proteomic signatures that predict clinical responses to diet across a span of ages.
- The contractor shall use the aptamer-based assay to measure levels of approximately 7,000 proteins including cytokines, growth factors, receptors, proteases, protease inhibitors, kinases, structural proteins, and hormones known to be important in human diseases.
- The assay should require approximately 100 microliters of plasma or serum and allow hundreds of assays to be run in apreallel 96-well plates.
- The contractor shall use a modified aptamer-based reagent comprised of synthetic single-stranded DNA sequences with protein-like appendages that bind to specific target proteins.
- The single-stranded DNA SOMAmer reagent should then be quantifiable by hybridization to a custom DNA microarray containing probes complementary to the SOMAmer sequences.
LEVEL OF EFFORT: Senior researcher or technical researcher.
GOVERNMENT RESPONSIBILITIES: The government shall provide adequate quantities of archived plasma samples to the contractor to enable the performance of the proteomic assays detailed above.
DELIVERY OR DELIVERABLES: The contractor shall provide an electronic copy of spreadsheet or database files including quantitative measurement of all proteins assayed in the provided plasma samples and relevant quality control metrics (including specimen usage, assay coefficients of variation, assay success/failure rates, normalization process) as well as an electronic copy of a report summarizing the laboratory methods and technical specifications used, both to be delivered within 365 calendar days of receipt of the samples by the contractor.
REPORTING REQUIREMENTS: The contractor shall submit via e-mail as PDF or a MS Word document a progress report during the contract period. The progress report shall include tasks completed and a list of tasks to be completed, inclusive of timeframe. This report shall also describe any problems that arose and state the resolution or provide an explanation if a solution was not identified.
TRAVEL: N/A
KEY PERSONNEL: The key personnel requirements for the senior researcher are as follows:
- A master’s or PhD in a laboratory science field
- Extensive experience in high throughput lab methods.
DATA RIGHTS: The National Institute on Aging shall have unlimited rights to and ownership of all deliverables provided under this contract including reports, recommendations, briefings, work plans and all other deliverables. This includes the deliverables provided under the basic contract and any optional task deliverables exercised by the contracting officer. In addition, it includes any additional deliverables required by contract change. The definition of “unlimited rights” is contained in Federal Acquisition Regulation (FAR) 27.401, “Definitions.” FAR clause 52.227-14, “Rights in Data-General,” is hereby incorporated by reference and made a part of this contract/order.
Section 508—Electronic and Information Technology Standards: The contractor is not required to develop, procure, maintain, or use Electronic and Information Technology (EIT) in the performance of the SOW.
CONFIDENTIALITY of INFORMATION: The government will not provide to the contractor any information or data of a personal nature about individual(s) or proprietary information or data pertaining to an institution or organization which is confidential.
Contract Type: A Firm Fixed Price type order award not exceeding the Simplified Acquisition Threshold is anticipated to be awarded resulting from this requirement.
SUMMARY STATEMENT:
The Unique Entity Identifier (UEI), the Taxpayer Identification Number (TIN), certification of country of ownership, and the certification of business size must be included in the response.
All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
Quoter Terms and Conditions (To be completed by the Offeror):
- Period of Performance OR Delivery Date After Receipt of Order:
- Shipping Point (F.O.B. OR Destination):
- Payment Discount Terms:
- NIH BPA Number:
- SAM UEI No:
- Name of Company:
- Street Address, City, State, Zip code:
- Name of Person Authorized to Provide Quote:
- Telephone Number and Email Address of Person Authorized to Provide Quote:
ADDITIONAL TERMS AND CONDITIONS, PROVISIONS, AND REPRESENTATIONS
The FAR Clauses are incorporated by reference and are provided in full text at https://www.acquisition.gov/
- FAR Provision 52.212-1 Instructions to Offerors-Commercial Items (Mar 2023) is applicable to this solicitation.
- FAR Provision 52.212.2 Evaluation-Commercial Items (Nov 2021) is applicable to this solicitation. The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes: Technical capability of the item offered to meet the Government requirement; Price; and Past performance [see FAR 13.106-2(b)(3)]
- FAR Provision 52.212-3, Offeror Representations and Certifications-Commercial Items (Dec 2022), is applicable to this solicitation.
- FAR Clause 52.212-4, Contract Terms and Conditions-Commercial Items (Dec 2022), is applicable to this solicitation.
- FAR clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (Jun 2023) is applicable to this solicitation.
- FAR Clause 52.227-14, Rights in Data - General
In addition, the following FAR provisions and clauses are applicable to this solicitation and incorporated by reference:
- 52.204-7 System for Award Management (Oct 2018),
- 52.204-13 System for Award Management Maintenance (Oct 2018),
- 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020),
- 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020)
- HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)
- FAR 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023)
The following provisions and clauses apply to this acquisition and are incorporated as an attachment. Offerors MUST complete the provision at 52.204-24 and 52.204-26 and submit completed copies as separate documents with their quotation.
- FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
- FAR 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)
- FAR 52.204-26, Covered Telecommunications Equipment or Services-Representation (Oct 2020)
- NIH Invoice and Payment Provisions
All responses must be received by September 17, 2023, at 5:00 pm EST and must reference announcement/ solicitation number NIA-23-011464. Responses may be submitted electronically to Carla Blalock (Carla.blalock@nih.gov). Fax responses will not be accepted.
Interested parties may identify in writing their interest and capability in response to this requirement. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.
All responses must be received by closing date and must reference the announcement. Responses may be submitted electronically to the attention of the contract specialist. Fax responses will not be accepted.
All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.