Whole Genome Sequencing (WGS) services for genetic testing of NIAID patients in clinical trials

PRE-SOLICITATION NOTICE **NOTICE OF INTENTNOI-NIAID-23-2183356NAICS – 541380, Testing ServicesThis is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on an other than full and open competition basis with Clinical Research Sequencing Platform, LLC of Cambridge, MA to procure Whole Genome Sequencing (WGS) needed to support a Division of Intramural Research (DIR) initiative involving genetic testing of all NIAID patients enrolled in clinical trials located at the NIH Clinical Center.The National Institute of Allergy and Infectious Disease (NIAID) Division of Intramural Research (DIR) scientists study all aspects of infectious diseases, including the causative agent, vectors, and pathogenesis in human and animal hosts. Clinical research is an integral part of this mission, enabling key lab discoveries to be rapidly translated into methods to prevent, diagnose,

or treat disease. DIR researchers annually conduct more than 200 clinical trials at the NIH Clinical Center on the Bethesda, Maryland, campus and at collaborating U.S. and international sites. In support of clinical research, the NIAID Centralized Sequencing Program (CSP) is a comprehensive program that obtains genetic testing, harmonizes phenotypic and genomic data, performs variant interpretation, and provides clinically validated results for patients enrolled in a diverse set of protocols at the NIH Clinical Center. The goal of the NIAID Centralized Sequencing Program is both to contribute to the understanding of underlying genetic etiology of disease and to address the clinical need for genomic evaluations. The purpose of this acquisition is to support the mission of DIR to obtain genetic testing for the NIAID Centralized Sequencing Program. The objective is to purchase whole genome sequencing services. The Centralized Sequencing Program will have direct implications for the care of NIH patients and for the discovery of disease mechanisms. Genome sequencing will allow for discovery of monogenic and polygenic contributions to immune system disorders. This work will have direct implications for the care of NIAID patients, who may be referred for bone marrow transplant as a result, and for the discovery of the mechanisms of human immunity. Due to the critical need to provide timely genomic evaluation for participants at NIAID, this acquisition is being awarded to this vendor in this one circumstance to conduct a NIAID Centralized Sequencing Program Genome Sequencing Pilot seeking high quality data with a faster turnaround time of 28 days and at a substantial cost savings over what has been previously used, as a trial run to review overall results.The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered by email (subject line to reference NOI-NIAID-23-2183356) to Dana Monroe at dana.monroe@nih.gov, by 5:00pm ET, Monday, August 7, 2023. All responses received by the closing date of this synopsis will be considered by the Government. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.