Notice of Intent to Sole Source - PacBio HiFi Genome Sequencing Services

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THIS IS A NOTICE OF INTENT AND NOT A REQUEST FOR QUOTATIONS

This notice is published in accordance with Federal Acquisition Regulation (FAR) 5.101(a)(1) requiring the dissemination of information regarding proposed contract actions. This is a Notice of Intent to award a sole source, firm-fixed price order under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1 - Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for competitive proposals.

The National Institute of Allergy and Infectious Diseases (NIAID) intends to negotiate on a sole source basis with Infinity Biologix LLC dba Sampled, 30 Knightsbridge, Building 3, Piscataway, NJ 08854.

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 comprehensive program that obtains genetic testing, harmonizes phenotypic and genomic data, performs variant interpretation, and provides clinically validated results for patients enrolled in 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 obtain genetic testing for the NIAID Centralized Sequencing Program to support the mission of DIR. The objective is to purchase research long read sequencing; 75 orders of Whole-Genome Sequencing Service PacBio Revio at both 20X and 30x coverage depths. Long read sequencing is needed to support a DIR initiative involving genetic testing of patients enrolled in clinical trials located at the NIH Clinical Center. Long read sequencing is the emerging as the new industry standard (compared to traditional short read genome data) to identify single nucleotide variants, structural variants, and variant phasing (cis v. trans). As well as epigenetic markers (methylation and acetylation).

Sampled is the only Certified Service Provider of PacBio HiFi long-read sequencing that can ensure we will continue to receive consistent and compatible data for this research project. The success of this multi-year project requires a smooth transition between fiscal year purchase orders. The only way to ensure a smooth transition is to have a consistent vendor utilizing the same sample preparation, data generation, and data delivery methodologies.

Switching vendors may produce inconsistencies between the data sets making them incompatible, hindering the impact of the prior investments in time and funding dedicated to this project. Therefore, switching vendors would limit the ability of this research project to inform up-to-date genetics-based approaches to healthcare at the NIH.

Period of Performance: July 30, 2025 – July 29, 2026

Place of Performance: Bethesda, MD.

The North American Industry Classification (NAICS) for this acquisition is 541380 – Testing Laboratories and Services, which has a size standard of $19 million. Sampled is an other than small business.

This will be the only notice of the Government's intent to solicit, negotiate, and award to one source to satisfy this requirement. The Government plans to award a contract for this requirement within 15 days of this notice.

While this synopsis does not constitute a solicitation, interested vendors may identify their interest and capability to satisfy this requirement. The Government understands that Sampled is the only vendor who can provide the requested services for NIAID. However, firms that believe they can provide the capability required to fully meet the Government's requirement may submit a capabilities statement, including past performance, in writing to the identified point of contact within 10 days after publication of this notice. Such documentation shall be evaluated solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Interested parties may identify their interest and capability to respond to the requirement or submit offers on NOI-NIAID-25-2261621.

This notice does not obligate the Government to award a contract or otherwise pay for any information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted.

For additional information or to submit responses, please contact Seth Schaffer, Contract Specialist at seth.schaffer@nih.gov.

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