Sol_75N98026Q01135.pdf

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National Institutes of Health OD - Office of Logistics and Acquisition Operations 6100 Executive Blvd., Room 6B05 Bethesda, MD 20892-7511

75N98026Q01135

NICHOLAS CAPOBIANCO

+10

000-000000

09/14/2026 1300 ED

Multiple

The purpose of this COMBINED SYNOPSIS /

SOLICITATION (COMPETITIVE - BRAND NAME)

is to acquire high-throughput proteomic screening and preliminary biostatistical analysis of approximately 258 anonymized human plasma and bone marrow plasma samples using the Olink® Explore HT platform.

The following FAR clauses and Provisions are applicable to this award.

FAR 52.204-13 System for Award

Management Maintenance (Oct 2018);

FAR 52.204-18 Commercial and Government

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Continued...

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NSN 7540-01-152-8067

75N98026Q01135

HHSAR 352.222-70, Contractor Cooperation in

Equal Employment Opportunity Investigations

(Dec 2015).

FAR 52.212-4 Contract Terms and Conditions -In addition to all the applicable commercial

Products and Commercial Services (Nov 2023)

52.217-8 - Option¿to Extend Services¿(Nov 1999)

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE

COMBINED SYNOPSIS / SOLICITATION (COMPETITIVE — BRAND NAME)

Title: Large-scale Blood Protein Testing and Data Analysis — Olink® Explore HT Proteomic Profiling Service (Brand Name)

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N98026Q01135. This solicitation is issued as a competitive combined synopsis/solicitation for commercial products or commercial services. The Government intends to award a purchase order resulting from this solicitation on a competitive basis limited to the Olink® Explore HT platform under the brand-name authority of FAR 13.106-1(b)(1). The associated brand-name justification is posted with this notice in accordance with FAR 5.102(a)(6). Competition is open to Olink Proteomics Inc.

and all currently Olink-certified service provider laboratories capable of delivering Olink® Explore HT data meeting the specifications below.

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and Simplified Acquisition Procedures at FAR Subpart 13.5. The total estimated value is below the Simplified Acquisition Threshold.

The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, seeks to award a firm-fixed-price purchase order to the responsible offeror whose proposal represents the best value to the Government.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2026-01, effective March 13, 2026.

(iv) The associated NAICS code is 541380, Testing Laboratories and Services, with a small business size standard of $19.0 million.

This requirement is unrestricted.

(v) Description of Requirement:

The National Heart, Lung, and Blood Institute (NHLBI), Hematology Branch (HB) requires high-throughput proteomic screening and preliminary biostatistical analysis of approximately 258 anonymized human plasma and bone marrow plasma samples using the Olink® Explore HT platform. The requirement is brand-name restricted to Olink® Explore HT because NHLBI's ongoing intramural research depends on the specific Proximity

Extension Assay (PEA) chemistry, Explore HT panel design, dual-antibody specificity profile, sample-processing workflow, quality-control metrics, and NPX-based data outputs of that platform for comparability with existing Olink datasets in the study program.

Technical Specifications — Salient Characteristics:

• Proximity Extension Assay (PEA) chemistry with dual-antibody recognition and Next Generation Sequencing (NGS) readout

• Simultaneous quantification of ≥5,000 unique human protein biomarkers per sample using the Olink® Explore HT panel

• Capacity to process the full sample set in the minimum practicable number of batches to control for inter-batch variability

• Validated performance on human EDTA plasma; contractor shall confirm capability and any special handling for bone marrow plasma matrix

• Sample volume requirement compatible with limited-volume clinical aliquots (≤2 µL per assay preferred)

• Data delivery in Normalized Protein Expression (NPX) format with accompanying Certificate of Analysis

• Current Olink certification for Explore HT service delivery (offerors shall provide evidence of certification and Olink Concordance Test results, if applicable)

Data Analysis Deliverables:

• Standard Olink quality control of resulting data (assay-level and sample-level QC metrics, intra- and inter-CVs, detectability, LOD per assay)

• Biostatistical support to examine correlations and differences between samples, sample types, and anonymized patient characteristics provided by NHLBI

• First-pass filtering of hits for clinical, biological, and/or statistical significance

• Return of all unused sample aliquots to NHLBI upon completion, with certification of secure destruction of any anonymized clinical data

Period of Performance / Deliverables Schedule:

• Initial data delivery: within three (3) months of receipt of samples from NHLBI

• Final data and biostatistical analyses: within twelve (12) months of receipt of samples from NHLBI

Security and Data Handling:

Personally identifiable information (PII) and protected health information (PHI) will not be provided to the contractor. Limited anonymized clinical data necessary for biostatistical analysis shall be securely stored during performance and destroyed upon completion, with written certification of destruction provided to the Government. Samples shall be provided as anonymized aliquots and stored securely until returned to NHLBI.

(vi) Delivery Location:

Samples will be shipped to the contractor's facility for processing and interim storage. Data deliverables and unused specimens shall be returned to:

David J. Young National Heart, Lung, and Blood Institute Bldg 10-CRC, RM 5-3150, MSC 1454 10 Center Drive Bethesda, MD 20892-1454

(301) 827-7823 david.young2@nih.gov

(vii) [Reserved]

(viii) FAR 52.204-7, System for Award Management, applies to this acquisition.

(ix) The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition. Offerors shall submit quotations in accordance with paragraph (xiv) below.

(x) The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

(a) The Government will award a purchase order resulting from this solicitation to the responsible offeror whose offer, conforming to the solicitation, represents the best value to the Government, price and other factors considered.

(b) Evaluation Factors (listed in descending order of importance; non-price factors, when combined, are approximately equal to price):

1. Technical Capability — Current Olink certification for Explore HT service delivery;

demonstrated ability to process the full sample set within a minimized batch structure; validated capability for the specified sample matrices (plasma and bone marrow plasma); adequacy of proposed QC and biostatistical approach.

2. Past Performance — Recent and relevant experience delivering Olink® Explore HT data for research studies of comparable scale and sample complexity, including any relevant Olink Concordance Test results.

3. Delivery Schedule — Ability to meet or improve upon the three-month initial and twelve-month final delivery milestones.

4. Price — Total evaluated price, including all sample processing, data analysis, biostatistical support, sample storage during performance, and return shipment of unused aliquots.

(c) A written notice of award or acceptance of an offer, issued within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer before the expiration date.

(xi) FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xii) Additional contract requirements or terms and conditions:

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders—Commercial Products and Commercial Services, applies.

Applicable clauses shall be identified in the resulting award.

• Inspection and Acceptance: All data deliverables shall be reviewed by the Project Officer, David J. Young, for completeness, adherence to Olink QC standards, and conformance to the specifications above. The Government reserves 30 calendar days after receipt of each deliverable for inspection and acceptance.

• Sample chain-of-custody: The contractor shall maintain documented chain-of-custody for all samples from receipt through return shipment. Samples shall be stored at contractor-standard conditions appropriate for plasma and bone marrow plasma preservation.

• Data destruction certification: Upon completion of the period of performance, the contractor shall provide written certification that all anonymized clinical data provided by NHLBI has been securely destroyed.

(xiii) The Defense Priorities and Allocations System (DPAS) is not applicable.

(xiv) Submission Requirements:

Responses must include sufficient information to demonstrate the offeror's capability to provide the required service. Quotations shall include, at a minimum:

• Evidence of current Olink certification for Explore HT service delivery

• Unit price per sample and total firm-fixed price for the estimated 258-sample scope, including all processing, QC, biostatistical analysis, sample storage during performance, and return shipping

• Any shipping and handling costs, itemized separately

• Proposed delivery timeframe after receipt of samples (initial data and final deliverables)

• Delivery terms and F.O.B. point (destination or origin)

• Technical approach addressing each salient characteristic in paragraph (v), including confirmation of capability for bone marrow plasma matrix

• Proposed batch structure and justification for minimizing inter-batch variability across the sample set

• Past performance information: two to three references for comparable Olink® Explore HT projects completed within the past three years, including point-of-contact information

• Any Olink Concordance Test results (if applicable)

• Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification under NAICS 541714

All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov at the time of quotation submission and through the date of award.

All responses must be received by September 14, 2026 at 1:00 PM EDT and must reference solicitation number 75N98026Q01135. Responses shall be submitted electronically to nicholas.capobianco@nih.gov.

(xv) Point of Contact:

Nicholas Capobianco Contracting Specialist National Institutes of Health Email: nicholas.capobianco@nih.gov

Statement of Work (SOW)

1. Project Title

Large-scale blood protein tes2ng and data analysis

2. Introduc3on and Background

The Na2onal Heart, Lung, and Blood Ins2tute (NHLBI), in collabora2on with the Na2onal Cancer Ins2tute (NCI) and Na2onal Human Genome Research Ins2tute (NHGRI), through transla2onal studies of large pa2ent biobanks, examines the role of various processes in human blood diseases including their causes, treatments and outcomes. Through collabora2ve long-term studies with NCI and NHGRI, NHLBI has curated a large collec2on of blood and bone marrow samples from pa2ents with gene2c disorders associated with blood diseases. The plasma (liquid phase) of such samples contain thousands of different proteins and other biomarkers whose abundance is being studied to understand how processes such as inflamma2on, cell-to-cell signaling, and drug therapies drive these chronic illnesses with the goal of iden2fying new markers of disease and/or targets for poten2al treatment.

3. Statement of Need and Objec3ves

The Na2onal Heart, Lung, and Blood ins2tute (NHLBI), Hematology Branch (HB) requires a high-throughput screen (HTS) capable of iden2fying and quan2fying proteins and other biomarkers from human blood and bone marrow plasma samples in an unbiased manner (i.e., biomarker discovery). In addi2on to handling and processing the samples provided by NHLBI, HB also requires basic analy2c and sta2s2cal support for quality-control and first-pass analyses of the resul2ng data from this HTS.

The Olink(R) Explore HT plaPorm is required because the research depends on the specific Olink(R) assay chemistry, Explore HT panel design, sample-processing workflow, quality control metrics, and data-analysis outputs. No other available HTS approaches meet these requirements. The requirement is limited to the analysis of research specimens and delivery of scien2fic data needed for ongoing NHLBI intramural research.

4. Product Specifica3ons/Features/Salient Characteris3cs

High-throughput screening (HTS):

Proximity extension assay (PEA)-based HTS HTS capable of iden2fying/quan2fying 5000+ proteins and other biomarkers in an unbiased fashion Minimum capacity of 172 samples per run to minimize batch effects

Data Analysis:

Ini2al quality control of resul2ng data Biosta2s2cal support to examine correla2ons and differences between samples, sample type, and key pa2ent characteris2cs (to be provided as anonymized data)

First-pass filtering of hits for clinical, biological and/or sta2s2cal significance

5. General Contractor Responsibili3es

Contractor will conduct processing and analysis of the supplied samples, ensuring quality controls (QC) are met, and provide data and analyses as noted above. Samples will be stored un2l QC and preliminary data acquisi2on is complete. Remaining sample not needed for analysis will be returned to NHLBI.

6. Delivery or Performance Loca3on

Samples will be shipped to the contractor for processing and storage at their local facility. Data and unused specimens will then be returned to:

David J. Young

Bldg 10-CRC, RM 5-3150, MSC 1454 10 Center Drive Bethesda, MD 20892-1454

(301) 827-7823 david.young2@nih.gov

7. Delivery Date

Ini2al data within 3 months of award and receipt of samples from NHLBI

Final data and biosta2s2cal analyses within 1 year of award and receipt of samples from NHLBI

8. Inspec3on and Acceptance

Data and results shall be reviewed with David Young for completeness and quality assurance

9. Point of Contact

David J. Young

Bldg 10-CRC, RM 5-3150, MSC 1454 10 Center Drive Bethesda, MD 20892-1454

10. Security

Personally iden2fiable informa2on (PII) and protected health informa2on (PHI) will not be provided to the contractor; however, it is expected that the limited, anonymized clinical data necessary for basic biosta2s2cs will be securely stored and destroyed upon comple2on of this work. Samples will also be provided as anonymized aliquots, but shall nonetheless be stored in a secure fashion un2l returned.

11. Government Furnished Property (GFP) and Government Furnished Informa3on (GFI)

No GFP or GFI is expected to be necessary for this contract.

12. Invoices

• Two-Way Invoices: The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing Platform (IPP) at:

1. https://www.ipp.gov and

2. NHLBIContractsBranchB@mail.nih.gov

• Invoices shall be submiged on a monthly basis no later than 10 business days aher the billing cycle of the previous month.

• Invoices shall include only those services rendered during the billing period.

• Invoices shall be billed at the rates, and in accordance with the Contract Line Item Number (CLIN), as listed in the Schedule of Items.

• The Contractor shall submit invoices to the Department of Treasury’s Invoice Processing

PlaPorm (IPP) at hgps://www.ipp.gov

Title