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CareDx Next Generation Sequencing Reagents for the Human Leukocyte Antigen Lab

POTS: 24-000007

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) intends to award a fixed price contract with a nine-month base period from 11/1/2023-8/31/2023 to CareDx Lab Solutions, Inc., West Chester, Pennsylvania 19382 on a sole source basis to provide the Next Generation Sequencing (NGS) reagents to the Department of Transfusion Medicine/Human Leukocyte Antigen (HLA) Lab at the NIH Clinical Center (CC).

The function of the Human Leukocyte Antigen Laboratory (HLA) of the Department of Transfusion Medicine, CC is to (1) provide clinical diagnostic laboratory testing for patients in the Clinical Center to facilitate possible transplant or enrollment into an appropriate protocol for the patient’s particular condition; (2) to conduct clinical consultations for Clinical Center physicians in the management of patient care in regards to potential transplant scenarios; (3) to maintain accreditation through various accrediting agencies in order to provide quality results (4) to conduct research in the development of new diagnostic laboratory tests (5) to facilitate the support and development of protocols which involve HLA testing and the implications for patient care.

The CareDx AlloSeq NGS kits provide the highest level of resolution available for HLA tying. CareDx reagents are the only reagents that have been extensively tested and validated for use on the existing Illumina MiSeq instrument in the HLA Laboratory to provide the required three field resolution necessary for the NIH transplantation protocols serviced. The high resolution enables the HLA Lab to provide the clinicians with the most complete information when searching for donors for a hematopoietic stem cell transplant. The higher the resolution, the better the chance of success for the transplant. Testing validation requires parallel testing with known samples and would involve up to two months of testing and additional funding to purchase the reagents. The American Society of Histocompatibility and Immunogenetics (ASHI) is the accrediting organization for HLA testing, and the current validation of the CareDx reagents has met all standards required.

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 CC, 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 October 23, 2023, at 6:30AM EST.

*****Please send capability statements only! This is not a request for proposal. Thank you! *****

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