CareDX Lab Solutions Inc. Allo Seq Tx17 Next Generation Sequencing (NGS) Reagent Kits

Title

CareDX Lab Solutions Inc. Allo Seq Tx17 Next Generation Sequencing (NGS) Reagent Kits

• Product Service Code: 6550
• NAICS Code: 541714
• Place of Performance:

Bethesda, MD 20892 USA

POTS: 26-000014

Description

This is a notice of intent, NOT a request for a quotation. A solicitation document will NOT be issued, and quotations will NOT be requested.

The National Institutes of Health (NIH) plans to issue a firm fixed-price purchase order to CareDx Lab Solutions Inc. located in West Chester, Pennsylvania, 19382, on a sole source basis. This order is for Next Generation Sequencing (NGS) reagent kits needed by the Department of Transfusion Medicine.

The purpose of this acquisition is for the National Institutes of Health (NIH) Human Leukocyte Antigen (HLA) Laboratory to secure a one-year supply of Next Generation Sequencing (NGS) reagents from CareDx Lab Solutions Inc. Shipments are planned for, February 2026, May 2026, and August 2026. These quarterly deliveries will ensure the HLA Lab maintains adequate stock for patient testing. The contract's performance period will run from January 16,2026 to September 30, 2026.

The NIH is the leading federally funded biomedical research institution in the United States, comprising twenty-seven Institutes and Centers. The NIH Clinical Center (CC), located on the NIH campus, serves as the onsite hospital, fully supporting clinical studies in both inpatient and outpatient settings. The NIH CC is an 870,000 square-foot facility equipped to accommodate 240 inpatient beds and 82 day-hospital stations.

The Human Leukocyte Antigen (HLA) Laboratory within the Department of Transfusion Medicine at the Clinical Center has several key functions:

1. To provide clinical diagnostic laboratory testing for patients at the Clinical Center, aiding in potential transplant eligibility or enrollment in relevant protocols for their specific conditions.
2. To offer clinical consultations to Clinical Center physicians regarding patient management in potential transplant scenarios.
3. To maintain accreditation from various accrediting agencies to ensure the delivery of quality results.
4. To engage in research aimed at developing new diagnostic laboratory tests.
5. To support and develop protocols that involve HLA testing and its implications for patient care.

The below items are required for this action:

Quantity/Item

80/ASTX.17 1(24)-RUO KIT

80/ASTX17.1(24), Box 1-RUO AlloSeq Tx 17 Kit Box 1 of 5 (24 Samples) - RUO  80/ASTX17.1(24), Box 2-RUO AlloSeq Tx 17 Kit Box 2 of 5 (24 Samples) - RUO 80/ASTX17.1(24), Box 3-RUO AlloSeq Tx 17 Kit Box 3 of 5 (24 Samples) - RUO 80/ASTX17.1(24), Box 4-RUO AlloSeq Tx 17 Kit Box 4 of 5 (24 Samples) - RUO 80/ASTX17.1(24), Box 5-RUO AlloSeq Tx 17 Kit Box 5 of 5 (24 Samples) – RUO

4/Dry Ice

4/Gel Packs

4/Freight

The proposed vendor, CareDx Lab Solutions Inc., is the sole manufacturer of these NGS reagents, which are currently utilized by the HLA lab. These reagents have undergone testing and validation. There are no known vendors that can provide these specific reagents.

This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1), For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available.  Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

Interested parties may identify their interest and capabilities in response to this posting. The determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.

Comments to this announcement, referencing this posting number, may be submitted to the Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Shasheshe Goolsby, Lead Contract Specialist, shasheshe.goolsby@nih.gov by January 10, 2026, 6:00AM EST.

*** Please send your capability statements ONLY. This IS NOT a request for proposal. ***