CareDx Next Generation Sequencing (NGS) Reagents for the HLA Lab

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 one (1) twelve-month base year 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.Good Laboratory Practice requires the availability of multiple reagents to resolve complex HLA testing issues.  The reagents provided by CareDx will fulfill this requirement.  Without a secondary option for NGS reagents, there could be a very large delay in obtaining results for the clinicians.  Additionally, even after the delay, there is a risk that the results may not be as specific as what would have been obtained by NGS.  NGS offers the highest resolution results for HLA typing of transplant recipients and donors.  The HLA Lab currently uses another vendor for the typing of the department's patients; however, good laboratory practice requires the availability of a secondary vendor’s reagents for clarification and resolution of complex typings.  The reagents provided by CareDx have been previously tested in the HLA Lab and have been proven to provide a greater ability to resolve problems.  Due to the quantity of tests required, it is in the best interest of the government for the HLA Lab to utilize CareDx as the primary NGS vendor.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 Kerry-Ann Chisholm, Contract Specialist, kerry-ann.chisholm@nih.gov by the due date and time marked in this notice.