Neurodegenerative Disease Research - Proteomic Analysis Services

SYNOPSIS WORKSHEET

NIH-NOI-26-PCA-NIA-01589 NAICS 541380 - TESTING LABORATORIES AND SERVICES

PSC Q301 Reference Laboratory Testing

This is a Notice of Intent (NOI). This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This is a Notice of Intent to award a sole source, firm-fixed price purchase order under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 13.106-1(b) and 13.501(a)- Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for quotes. The National Institutes of Health (NIH) intends to negotiate on an other than full and open competition to the maximum extent practicable consistent with the agency's minimum needs. For this acquisition, however, full and open competition is not contemplated. The acquisition is being conducted under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Based on the market research conducted, Banner Sun Health is the only known source capable of providing the required NULISA protein analysis services together with the established and validated quality control (QC) bridging cohort necessary to meet the Government's minimum needs. The Government's requirement is not limited to routine NULISA assay execution. It includes the ability to support: - Longitudinal analytical consistency across assay runs, batches, and study periods; - Assessment and correction of analytical drift; - Normalization of datasets generated over time; and - Harmonization of current project data with future datasets and external collaborators. Banner Sun Health is uniquely qualified because it already maintains a dedicated, validated, matrix-matched, dynamic-range-qualified, and biobanked NULISA QC bridging cohort designed specifically for these purposes. No other known source was identified that could provide this capability immediately and without substantial duplication of cost, unacceptable delay, and unacceptable risk to scientific validity and data integrity. The Period of Performance shall consist of one (1) twelve-month base period and two (2) twelve-month option periods, as follows:

Base Period

8/1/2026 7/31/2027

Option Period One

8/1/2027 7/31/2028

Option Period Two

8/1/2028 7/31/2029 Services shall be performed in Bethesda, MD. The NIH Intramural Center for Alzheimer's Disease and Related Dementias (CARD) is an interdisciplinary initiative dedicated to advancing the understanding, diagnosis, and treatment of Alzheimer's disease and related dementias. CARD supports translational and clinical research efforts designed to improve scientific knowledge of disease mechanisms and accelerate the development of effective diagnostic and therapeutic strategies. Biomarkers are central to this mission. They are essential for understanding disease biology, identifying molecular changes associated with disease onset and progression, supporting diagnosis, monitoring disease progression, and evaluating therapeutic efficacy. CARD requires access to advanced biomarker testing technologies to analyze well-characterized patient samples and generate high-quality data that can be integrated with clinical and phenotypic information. This requirement is for NULISA (a novel proteomic liquid biopsy platform with attomolar sensitivity and high multiplexing) testing services to identify biomarkers that provide information about the underlying molecular changes associated with Alzheimer's Disease/Related Dementia's (AD/ADRD). The resulting data will support NIH research efforts focused on molecular characterization, biomarker discovery, and translational applications relevant to Alzheimer's disease and related dementias. NIH requires immediate access to an existing and validated NULISA QC bridging framework to support ongoing research without interruption. Any alternate vendor would need time to create and validate a comparable bridging cohort, which would cause unacceptable delay to project execution. Delays in establishing a new QC framework could disrupt continuity of biomarker testing and reduce comparability with prior and future datasets. The existing Banner Sun Health cohort is already biobanked and available for use, making it compatible with the required project start and continuity needs. The North American Industry Classification (NAICS) code for this acquisition is 541380 - TESTING LABORATORIES AND SERVICES which has a size standard of $19.0 Million. Banner Health is an other than small business. This will be the only notice of the Government's intent to solicit, negotiate, and award to one source to satisfy this requirement. The Government plans to award a contract for this requirement within 90 days of this notice. While this synopsis does not constitute a solicitation, interested vendors may identify their interest and capability to satisfy this requirement. The Government understands that Banner Health is the only vendor who can provide required laboratory services for biomarker identification. However, firms that believe they can provide the capability required to fully meet the Government's requirement may submit a capabilities statement, including past performance, in writing to the identified point of contact within fifteen (15) days after publication of this notice. Such documentation shall be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Interested parties may identify their interest and capability to respond to the requirement or submit offers on NIH-NOI-26-PCA-NIA-01589. This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. For additional information or to submit responses, please contact Linda Smith, Supervisory Contract Specialist at linda.smith2@nih.gov and Danielle Tines at Danielle.tines@nih.gov