SYNOPSIS WORKSHEET

NOI-NIAID-26-2280298

NAICS – 325414 – Biological Product (except Diganostic) Manufacturing

6550- IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS

THIS IS A NOTICE OF INTENT AND NOT A REQUEST FOR QUOTATIONS.

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)(2) and 13.501(a) - Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for competitive proposals.

The National Institute of Allergy and Infectious Diseases (NIAID) intends to negotiate on a sole source basis with SomaLogic Operating Co, Inc, 2945 Wilderness Place, Boulder, CO 80301 on an other than full and open competition basis to obtain SomaScan 7KPlasma (900-00020), Serum (900- 200021), Urine (900-00026), Cerebral Spinal Fluid (900-00025), Cell and Tissue Kits (900-00027) and/or 11K Plasma (900-00050), Serum (900-00051), CSF (900-00055), Cell and Tissue (900- 00057) Assay Kits. QTY 15.

Justification:

The CHI develops and applies systems biology approaches combining computation, modeling, and experimental data to study the immune system at the organismal, cellular, and molecular levels. The proteomic data generated from the samples that will be run on the assay from this acquisition will be coupled to information from orthogonal experimental techniques to uncover an immunology-based model of disease systems. The government requires SomaScan 7K and 11K assay kits, manufactured by SomaLogic Operating Co. (SomaLogic), to measure 11,000 proteins across 10 logs of concentration dynamic range in <150 uL of human biological samples (Serum, Plasma, CSF, Urine, Cell Lysate, Tissue Homogenate, etc.) with median %CV <5% across all analytes. The data generated from the SomaScan 7K and 11K assay kits must be directly comparable to previously generated data that utilized the SomaScan 7K and 11K assay kits as many of the studies utilizing this requirement are continuations of longitudinal studies, and any differences in data comparability may result in detrimental impacts such as the creation of data artifacts that cannot be overcome as well as potential damage to study data integrity where remediation would not be possible.

The purpose of this acquisition is to purchase 15 SomaScan 7K and 11K assay kits for the Center for Human Immunology (CHI) for the ability to analyze clinical samples (serum, plasma, cell lysates, tissue homogenates, urine, and cerebrospinal fluid) with highly multiplexed analytes and high throughput proteins. The kits will be used to measure 11,000 proteins across 10 logs of concentration dynamic range in less than 150 uL of human biological samples with median %CV<5% across all analytes. Currently, there are numerous CHI projects and NIH fee-for-service customers from various institutes and centers in the NIH Intramural Research Program (IRP) that are awaiting their samples to be run on the platform for their clinical protocols.

The purpose of this acquisition is to procure 15 SomaScan 7K and 11K assay kits to run samples to generate proteomic data for various studies and projects for NIAID and other institutes and centers at the NIH on the existing SomaScan V4.1 Assay, which runs on a Tecan fluent liquid handling platform. These assay kits have been integrated into longitudinal studies and are required for the final step in those projects that have spanned across multiple years dating back to 2015. Moreover, they are critical for work on ongoing clinical trials as well. The assay kits are unique in that they can rapidly and simultaneously measure more than 11,000 low and highabundance proteins across 10 logs of dynamic range (concentration) with very high accuracy and reproducibility (median %CV of replicate measurements less than 5%) and low sample volume input requirements (less than 55uL).

They enable highly multiplexed (greater than 11,000 analytes) and high throughput (96 samples per kit) analysis of 11,000 proteins in clinical samples (e.g., human serum, plasma, cell lysates, tissue homogenates, urine, cerebrospinal fluid, etc.). Other technologies in this field, including other affinity-based protein assays, targeted protein assays, or mass-spectrometry based proteomic detection assays and technologies can only do some, but not all, of the capabilities of the SomaScan Assay. Furthermore, alternative technologies measure fewer proteins than the SomaScan Assay, do not have the ability to detect low abundance proteins (e.g. cytokines) as is possible with the SomaScan Assay, require patient sample volumes that far exceed what is required with the SomaScan Assay and more sample volume than is available to be analyzed, have poorer reproducibility than the SomaScan Assay leading to nondetection of biological signal changes, have sample throughputs far lower than that of the SomaScan Assay leading to increased wait times, labor costs, and delayed results; and the cost to run samples is far greater with other technologies than to run them on the SomaScan Assay. In addition to being independently verified in peer-reviewed scientific papers, the capabilities of the SomaScan Assay have also been verified by direct testing in our lab, and is therefore, the reason why the SomaScan Assay was selected in our laboratory for this type of work. The proteomic data generated from the samples run on the assay from this acquisition will be coupled to information from orthogonal experimental techniques to uncover a systems immunology-based model of disease. The data generated from the assay kits must be directly comparable to previously generated data from utilization of the SomaScan 7K and 11K assay kits.

Many studies utilizing this requirement are continuations of longitudinal studies, and any differences in data comparability could create data artifacts that cannot be overcome as well as potentially damage study data integrity. If alternative technologies and kits, other than the existing SomaScan Assay and the proprietary SomaScan 7K and 11K assay kits, are used for this work, the samples previously analyzed with the SomaScan Assay may not be directly comparable to those analyzed on other platforms. This could necessitate significant costs and resources to re-analyze these samples.

Furthermore, some of the previously analyzed samples have no remaining sample volume.

Additionally, alternative platforms may produce inferior, unreliable, and incomplete Only one award will be made because of this notice. This will be awarded as a firm-fixed price purchase order.

Shipping cost FOB destinations to BLDG 10 - Clinical Center 7th Floor, Wing N 10 Center Drive Bethesda, MD 20814

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 7 days of this notice.

The statutory authority for this sole source requirement is 41 U.S.C. 253(c)(1) as implemented by FAR 6.302-1 (b)(1)(i) only one source available, no substitutions possible. THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS All responsible sources that could provide comparable services may submit a capability statement that will be considered by email to Linda Smith at Linda.Smith2@nih.gov by 5:00 pm EST on May 13, 2026. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Any responses received by NIAID after this date and exact time specified are late and will not be considered.

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 it’s 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, Contracting Officer at Linda.smith2@nih.gov or Jessica Emerson, Procurement Technician at Jessica.emerson@nih.gov mailto:Linda.Smith2@nih.gov mailto:Linda.smith2@nih.gov mailto:Jessica.emerson@nih.gov