Proteomic Biomarker Testing Services Using CNS Panel 220 Argo NULISA Platform

SOURCES SOUGHT NOTICE

Proteomic Biomarker Testing Services Using CNS Panel 220 Argo NULISA Platform

Notice Type: Sources Sought / Market Research
Agency: Department of Health and Human Services (HHS), National Institutes of Health (NIH)
Office: NIA/CARD
Notice Number: SS-NIH-PCA-NIA-01589
PSC: Q301 – Medical Laboratory Testing
NAICS: 541380 – Testing Laboratories and Services
Response Due Date: May 13, 2026 11:00am EST

DISCLAIMER

This is a Sources Sought Notice issued solely for information and planning purposes and does not constitute a solicitation. This notice is issued in accordance with FAR Part 10, Market Research. This is not a Request for Proposal (RFP), Request for Quotation (RFQ), or Invitation for Bid (IFB), and it does not obligate the Government to award a contract or otherwise pay for the information submitted.

The purpose of this notice is to identify qualified and interested sources capable of meeting the Government’s requirement and to assist the Government in determining the appropriate acquisition strategy, including whether a set-aside is feasible.

Responses to this notice are voluntary. The Government will not reimburse any costs incurred in preparing or submitting a response. Any information received may be used by the Government for planning purposes only.

1. TITLE

Proteomic Biomarker Testing Services for Alzheimer’s Disease and Related Dementias Research Using the CNS Panel 220 Argo NULISA Platform

2. INTRODUCTION

The National Institutes of Health (NIH), Intramural Center for Alzheimer’s Disease and Related Dementias, is conducting market research to determine the availability and capability of qualified contractors to provide proteomic biomarker testing services using the CNS panel 220 Argo NULISA platform for Government-furnished biospecimens.

The Government seeks sources capable of performing high-throughput, quality-controlled proteomic testing and providing associated data files, quality control documentation, and harmonization-related reporting to support Alzheimer’s disease and related dementias (AD/ADRD) research.

3. BACKGROUND

The NIH Intramural Center for Alzheimer’s Disease and Related Dementias is an interdisciplinary initiative dedicated to advancing the understanding, diagnosis, and treatment of Alzheimer’s disease and related dementias. Biomarkers are critical for understanding disease mechanisms, supporting diagnosis, and monitoring disease progression and therapeutic efficacy.

NIH requires standardized, high-throughput proteomic analysis to support these objectives. The Government intends to furnish biospecimens from well-characterized patient cohorts for testing using the CNS panel 220 Argo NULISA platform. Resulting data will be used to identify biomarkers associated with underlying molecular changes in AD/ADRD and to support cross-cohort harmonization and downstream scientific analysis.

4. OBJECTIVE

The objective of this requirement is to obtain high-quality proteomic biomarker data from Government-furnished biospecimens through standardized NULISA testing, including:

• appropriate normalization,
• bridging controls,
• quality control procedures, and
• reporting sufficient to support cross-cohort harmonization and downstream scientific analysis.

5. DRAFT REQUIREMENT / SCOPE OF WORK

The Contractor shall furnish all management, supervision, labor, facilities, materials, equipment, supplies, transportation, and other resources necessary to perform the required services, except as otherwise specified as Government-furnished.

The Contractor shall perform CNS panel 220 Argo NULISA proteomic analysis on Government-furnished biospecimens and generate quality control data and required reports in accordance with the terms of any resulting contract.

5.1 Sample Processing Volumes

The Contractor shall be capable of processing up to the following maximum number of biospecimens during each contract period:

Base Year: August 1, 2026 through July 31, 2027

Maximum total: 8,970 samples

• PREVENT-AD cohort: 3,738
• Geneva cohort: 2,131
• DABNI/SPUN cohort: 3,101

Option Year 1: August 1, 2027 through July 31, 2028

Maximum total: 8,970 samples

• DABNI/SPUN cohort: 1,406
• K-ROAD cohort: 7,564

Option Year 2: August 1, 2028 through July 31, 2029

Maximum total: 8,970 samples

• K-ROAD cohort: 1,236
• Unspecified neurodegenerative disease cohort: 7,734

The Government does not guarantee a minimum quantity. Quantities are maximum estimated quantities for planning purposes unless otherwise stated in any resulting solicitation or award.

5.2 Required Analytical Services

The Contractor shall be capable of performing the following:

1. Perform CNS panel 220 Argo NULISA proteomic analysis on all Government-furnished biospecimens submitted under the contract.
2. Run pooled Government samples with known analytes on each plate for normalization during quantification of proteins and library preparation, when such samples are furnished by the Government.
3. Include a NuLISA quality control bridging cohort to assess analytical performance over time and normalize datasets.
4. Ensure the QC bridging cohort is matched to the relevant biofluid of interest, including:
   • cerebrospinal fluid (CSF), or
   • EDTA plasma.
5. Use the QC bridging cohort across multiple Government sample cohorts to support dataset harmonization among cohorts.
6. Use the QC bridging cohort to control for:
   • lot-to-lot variation,
   • between-cohort variation, and
   • batch effects requiring correction.
7. Include quality control measures consisting of:
   • a NuLISA plate for external controls, and
   • internal Contractor controls sufficient to monitor and control individual plate variance.
8. Maintain throughput capacity sufficient to prepare NuLISA libraries for up to 2,400 samples per week.
9. Provide raw sequencing data in FASTQ format via a secure cloud-based delivery method within two (2) weeks after receipt of prepared libraries, unless otherwise approved in writing by the Contracting Officer.
10. Perform quality control review of generated data and provide final QC-reviewed results to the Government within an additional two (2) weeks, provided all applicable QC benchmarks have been met.

5.3 Standards of Performance

The Contractor shall perform all services in a timely, competent, and professional manner consistent with:

• current manufacturer platform requirements;
• accepted industry standards for proteomic laboratory analysis;
• all applicable federal, state, and local laws and regulations; and
• the terms and conditions of any resulting contract.

5.4 Contractor Responsibility

The Contractor shall be responsible for the professional quality, technical accuracy, completeness, and coordination of all services performed. The Contractor shall, without additional compensation, correct or revise any errors, omissions, deficiencies, or nonconforming services resulting from Contractor fault or failure to comply with contract requirements.

6. PERIOD OF PERFORMANCE

The anticipated period of performance is:

• Base Year: August 1, 2026 through July 31, 2027
• Option Year 1: August 1, 2027 through July 31, 2028
• Option Year 2: August 1, 2028 through July 31, 2029

Exercise of options, if any, will be at the sole discretion of the Government.

7. PLACE OF PERFORMANCE

The principal place of performance is anticipated to be the Contractor’s facility or facilities, unless otherwise approved by the Government.

No travel is anticipated under this requirement.

8. DELIVERABLES

The Government anticipates requiring the following deliverables, as applicable to each cohort, batch, or reporting period:

1. Biomarker Readout File(s): CSV files containing log2 values for each biomarker.
2. Data Quality Control File(s): CSV files containing QC metrics and results.
3. QC Summary Report(s): PDF report(s) summarizing cohort-level and batch-level QC findings.
4. Raw Sequencing Data: FASTQ files delivered through a secure cloud server or other Government-approved secure method.
5. Bridging Sample Results: Separate CSV and PDF files documenting bridging cohort results and interpretation.
6. Study QC Results: Separate CSV and PDF files documenting study-level QC and harmonization-related findings.

Anticipated Delivery Schedule

Unless otherwise approved in writing by the Contracting Officer:

• Raw sequencing data in FASTQ format shall be delivered within two (2) weeks after receipt of prepared libraries.
• Biomarker readouts, QC data files, and QC summary reports shall be delivered within two (2) weeks of sample processing.
• Final QC-reviewed results shall be delivered within an additional two (2) weeks, provided QC benchmarks are met.

9. CONTRACTOR REQUIREMENTS

Interested sources should be capable of providing:

• qualified personnel with appropriate education, training, and experience;
• a designated Project Manager with authority to act on behalf of the Contractor;
• laboratory procedures and quality systems sufficient to support high-throughput proteomic analysis;
• secure handling of biospecimens and data;
• compliance with confidentiality, privacy, data protection, shipping, workplace safety, records retention, and inspection requirements; and
• management and oversight of any subcontractors used in performance.

10. GOVERNMENT-FURNISHED PROPERTY / INFORMATION

The Government anticipates furnishing, as applicable and available:

• biospecimens and associated information necessary for performance;
• pooled Government samples with known analytes for normalization, if applicable;
• technical coordination through a designated Government point of contact; and
• review and acceptance of submitted deliverables.

11. CONFIDENTIALITY, DATA PROTECTION, AND SECURITY

The Contractor shall be required to protect all Government-furnished information, biospecimens, data, and materials against unauthorized access, use, disclosure, modification, loss, or destruction.

The Contractor shall use Government-furnished biospecimens, data, and information solely for purposes of contract performance and for no other purpose unless expressly authorized in writing by the Contracting Officer.

The Contractor shall implement and maintain appropriate administrative, technical, and physical safeguards, including:

• access controls limiting access to authorized personnel;
• secure storage of physical and electronic materials;
• secure transmission methods;
• password protection or equivalent controls for electronic files; and
• procedures for incident reporting and response.

To the extent the Contractor receives or accesses personally identifiable information (PII), protected health information (PHI), coded human subject data, or other sensitive information, the Contractor shall comply with all applicable federal laws, regulations, HHS/NIH policies, and contract clauses governing privacy, confidentiality, and information security.

12. MARKET RESEARCH QUESTIONS / CAPABILITY QUESTIONS

Interested parties shall submit a capability statement that addresses the questions below. The Government requests clear, concise responses sufficient to assess the respondent’s capability and business status.

12.1 Company Information

Provide the following:

1. Company name
2. SAM Unique Entity ID (UEI)
3. CAGE code
4. Business size under NAICS 541380
5. Socioeconomic status, if applicable:
   • Small Business
   • Small Disadvantaged Business
   • 8(a)
   • HUBZone
   • SDVOSB
   • WOSB/EDWOSB
6. Name, title, phone number, and email address of the point of contact
7. Company address and place(s) of performance
8. Website address

12.2 Technical Capability Questions

Please address the following:

1. Does your organization currently perform CNS panel 220 Argo NULISA testing? If yes, describe your capability, platform access, and whether testing is performed in-house.
2. If your organization does not currently perform CNS panel 220 Argo NULISA testing, describe any equivalent or closely related proteomic biomarker testing capabilities and explain how your organization would meet this requirement.
3. Describe your experience processing human biospecimens, including:
   • cerebrospinal fluid (CSF),
   • EDTA plasma, and
   • other relevant biofluids.
4. Describe your maximum weekly throughput capacity and whether your organization can support preparation of NuLISA libraries for up to 2,400 samples per week.
5. Describe your quality control procedures for:
   • plate-level controls,
   • external controls,
   • internal controls,
   • bridging cohorts,
   • lot-to-lot variation,
   • batch effects, and
   • between-cohort harmonization.
6. Describe your experience using pooled control samples with known analytes for normalization.
7. Describe your ability to provide the following deliverables in the required formats and timelines:
   • CSV biomarker readout files with log2 values,
   • CSV QC files,
   • PDF QC summary reports,
   • FASTQ raw sequencing files,
   • bridging sample result files, and
   • study QC result files.
8. Describe your laboratory quality system, including any certifications, accreditations, CLIA status, CAP accreditation, ISO standards, or other relevant quality frameworks.
9. Describe your data management and secure transmission capabilities, including secure cloud-based delivery methods.
10. Describe your procedures for protecting Government-furnished biospecimens and sensitive data, including incident response procedures.
11. Describe your project management approach for handling multiple cohorts, batch scheduling, issue escalation, and deliverable tracking.
12. Identify any limitations, assumptions, or dependencies the Government should consider regarding this requirement.

12.3 Relevant Experience / Past Performance

Provide up to three (3) examples of recent and relevant projects performed within the last five (5) years that are similar in scope, size, and complexity. For each example, include:

1. Customer name
2. Contract number or agreement number, if applicable
3. Period of performance
4. Description of services provided
5. Approximate number of samples processed
6. Biospecimen types analyzed
7. Whether the work involved:
   • proteomic biomarker testing,
   • high-throughput laboratory processing,
   • bridging controls,
   • harmonization across cohorts,
   • secure data delivery, and
   • QC reporting
8. Customer point of contact, if available and releasable

12.4 Business and Acquisition Strategy Questions

Please address the following:

1. Is your organization interested in serving as a prime contractor for this requirement?
2. If not, would your organization be interested in participating as a subcontractor or team member?
3. If your organization is a small business, do you believe this requirement is suitable for a small business set-aside under NAICS 541380? Please explain why or why not.
4. If a set-aside is not feasible, identify which portions of the requirement, if any, could reasonably be subcontracted to small businesses.
5. Identify any contract type recommendations the Government should consider for this requirement (e.g., fixed-price, IDIQ, requirements-type, etc.), with rationale.
6. Identify any anticipated risks or challenges associated with performance of this requirement.

13. RESPONSE INSTRUCTIONS

Interested parties shall submit an electronic capability statement in response to this notice.

Submission Requirements

Responses should include:

• a cover page containing the notice number, company name, UEI, CAGE code, business size, and point of contact information;
• responses to the capability questions in Section 12; and
• any additional information the respondent believes is relevant to the Government’s market research.

Responses should be limited to 5 pages, excluding the cover page. The Government requests that responses be submitted in PDF format.

Submission Method

Responses shall be submitted by email to:

Linda Smith, Contracting Officer
Email: linda.smith2@nih.gov

Subject Line

Sources Sought Response – Proteomic Biomarker Testing Services / CNS Panel 220 Argo NULISA

Due Date

Responses are due no later than:

5/13/2026 11:00am EST

Late responses will not be considered.

14. QUESTIONS REGARDING THIS NOTICE

Questions regarding this Sources Sought Notice may be submitted by email to the point of contact identified above no later than 5/13/2026 11:00am EST.

15. ADDITIONAL INFORMATION

This notice is for market research purposes only. The Government may use the information received to:

• determine whether adequate competition exists;
• determine whether a small business set-aside is appropriate;
• refine the requirement;
• finalize the acquisition strategy; and
• identify capable sources.

The Government reserves the right to consider a firm’s failure to provide a complete response as an indication that the firm may not be capable of satisfying the requirement.