IDT_Sole_Source_Synopsis_(1)_1.docx

PUBLIC NOTICE OF PROPOSED ACQUISITION

Office of Acquisitions, Office of Management National Heart, Lung, and Blood Institute

(FAR Subparts 5.101(a)(2))

1. Announcement/Number: 75N98026Q01200

2. Post Date: September 11, 2026

3. Closing Response Date: September 14, 2026

4. Proposed Award Date: 9/30/26

5. Project Title: Methylation Sequencing Library Preparation Kits for Cell-Free DNA Analysis in Organ Transplants

6. Contracting Office: R&D and Professional Services - Division B, OALM Office of the Director, National Institutes of Health, 6701 Rockledge Drive, Rockledge Building 2, Suite 400, Bethesda, Maryland 20892-7902

7. Contact Point/Contracting Officer/Contract Specialist: Rashida Ferebee- Rashida.Ferebee@nih.gov

8. Acquisition Authority: This acquisition is being conducted under Federal Acquisition Regulations (FAR) Part 13 - Simplified Acquisition Procedures, and the resultant award will include all applicable provisions and clauses in effect through Federal Acquisition Circular 2026-01.

9. North American Classification System (NAICS) Code: 325414

10. Small business size standard: 1,250 Employees

11. Classification Code: 6505 - Drugs and Biologicals

12. Set-aside Status: None, this is a single-sole source (including brand-name) non-competitive action.

13. Description: The National Heart, Lung, and Blood Institute (NHLBI), Division of Intramural Research (DIR), Laboratory of Applied Precision Omics requires Integrated DNA Technologies (IDT) methylation sequencing library preparation products to support research on methylation profiles of cell-free DNA (cfDNA) in organ transplant recipients. Epigenetic profiling of cfDNA, particularly DNA methylation analysis, is used to characterize tissue- and cell-type-specific signatures associated with allograft status and organ injury. Accurate and reproducible methylation profiling is fundamental to the scientific objectives of this ongoing clinical research program.

The required products are xGen Methyl-Seq Library Prep, Catalog No. 10009824; xGen 2S Plus DNA Library Prep, Catalog No. 10009878; and xGen UDI 10nt Primer Plates 1-16, Catalog No. 10008054. The requisition includes 12 kits of xGen Methyl-Seq Library Prep, 6 kits of xGen 2S Plus DNA Library Prep, and 1 kit of xGen UDI 10nt Primer Plates 1-16, plus shipping and handling, for a total estimated cost of $77,117.11.

The specific IDT (Swift Biosciences) kits have been evaluated and validated by the laboratory using clinical samples from organ transplant patients. The established laboratory workflow depends on continued use of these products to maintain consistency and comparability of results across the study cohort.

14. Statutory Authority:

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13 - Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), Soliciting from a single source, and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13 - Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6 - Competition Requirements.

15. Single-sole Source (Including brand-name) Determination:

The determination by the Government to make a single-sole source (including brand-name) award is based on the market research and technical evaluation supporting this acquisition. Several DNA methylation sequencing library preparation kits are commercially available; however, each uses a distinct specialized workflow. Through evaluation using clinical samples from organ transplant patients, the laboratory identified the IDT (Swift Biosciences) kits as the optimal products for this research application. The IDT workflow is specifically designed to minimize adapter and primer dimer formation, a technical challenge in cell-free DNA library preparation that can reduce sequencing quality and data yield. In the laboratory's evaluation, the IDT kits consistently produced the highest-quality and most reproducible next-generation sequencing results for methylated DNA from transplant patient samples. Because the established laboratory workflow is built around these validated kits, continued use is essential to ensure data consistency and comparability across the study cohort. Accordingly, Integrated DNA Technologies is the recommended source for the required products.

16. Closing Statement:

This notice is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses shall contain sufficient information to establish the interested party's bona-fide capability to fulfill the requirement and include unit price, list price, shipping and handling costs, delivery period after award, prompt payment discount terms, F.O.B. point (Destination or Origin), Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and certification of business size. All offerors must have an active registration in the System for Award Management (SAM).

A determination by the Government not to compete this proposed action based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by the closing response date and time identified in this notice. Responses must be submitted via email to the Contract Specialist and Contracting Officer identified above.

All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

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