High depth of coverage (1000X) exome sequencing services for the NIAID Centralized Sequencing Program

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 purchase order under the authority of 41 U.S.C. 3304(a)(1), as implemented by FAR 13.106-1(b)(2) and 13.501(a) - Only One Responsible Source and No Other Supplies or Service Will Satisfy Agency Requirements and is not a request for competitive proposals. This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2025-05 August 7, 2025. The North American Industry Classification System (NAICS) code for this procurement is 541380, Testing Laboratories and Services, with a small business size standard of $19.0 million. The requirement is being competed, full and open competition, un-restricted and without a small business set-aside. The National Institute of Allergy and Infectious Diseases (NIAID), intends to negotiate on a sole source basis with Baylor College of Medicine, Human Genome Sequencing Center, One Baylor Plaza, MSC BCM-226, Huston, Texas 77030. The purpose of this acquisition is to advance the mission of the Division of Intramural Research (DIR) by enabling access to state-of-the-art genetic testing through the NIAID Centralized Sequencing Program. Specifically, the objective is to acquire high-depth (1000X) exome sequencing services. This level of sequencing coverage represents a significant enhancement over conventional exome sequencing, which typically achieves much lower coverage. High-depth (1000X) exome sequencing is a powerful and essential research tool for the detection of mosaic variants'genetic changes that are present in only a fraction of an individual's cells. These mosaic variants are often undetectable using standard exome or genome sequencing approaches, which generally provide insufficient coverage to reliably identify low-frequency variants. By increasing the sequencing depth to 1000X, the sensitivity for detecting these rare and potentially clinically significant variants is greatly improved. Unlike targeted deep sequencing panels, which focus on a limited set of genes and therefore sacrifice breadth for depth, high-depth exome sequencing maintains comprehensive coverage across the entire exome. This approach ensures that no genes are excluded from analysis, thereby maximizing the potential for novel gene discovery and comprehensive variant detection. This is particularly important for research and clinical investigations where the genetic basis of disease is unknown or may involve genes not previously associated with the phenotype under study. The results generated from this high-depth exome sequencing will have immediate and direct implications for the care of NIH patients. By enabling the detection of mosaic variants that would otherwise go unnoticed, this approach can inform more accurate diagnoses, guide clinical management, and potentially identify new therapeutic targets. Furthermore, the comprehensive nature of the data will facilitate the discovery of novel disease mechanisms, contributing to the broader scientific understanding of genetic disorders. In summary, the acquisition of 1000X exome sequencing services is critical for supporting the DIR's mission to conduct cutting-edge research and provide exemplary patient care. This technology will empower researchers and clinicians to uncover genetic variants that are invisible to conventional methods, thereby advancing both the science and practice of genomic medicine at the NIH. Specifically, the need is to obtain 1000X Exome Sequencing test listed below: NSX_WES_Hybs16plex_Seq8plex Samples, Quantity 336 Samples Samples will be provided over a twelve (12) month period Samples will be shipped to Building 15, Room 104, E2, Bethesda, Maryland 20892 Baylor is the only known source to meet the government's requirement for high depth exome sequencing'specifically, the 1000X Exome Sequencing test'is uniquely fulfilled by the Human Genome Sequencing Center (HGSC) at Baylor College of Medicine. Baylor's HGSC stands as the sole vendor capable of providing this specialized service, which delivers comprehensive exome coverage at an unprecedented depth, enabling the reliable detection of mosaic variants and low-frequency mutations that are routinely missed by conventional exome or genome sequencing platforms. The - 1000X Exome Sequencing test employs Baylor's proprietary protocols, advanced sequencing technologies, and rigorous quality control measures to ensure the generation of high-quality validated data with rapid turnaround times. This test is distinguished by its ability to combine high coverage with the full breadth of exome interrogation, a capability not advertised, to our knowledge, by any other commercial or academic sequencing provider. Baylor's HGSC has a proven track record of delivering reliable, reproducible, and actionable results that meet the stringent requirements necessary for both clinical and research applications. The critical need to provide timely, targeted exome evaluation for NIAID research participants can only be met by Baylor's unique offering, which supports both patient care and the advancement of scientific discovery. Other sequencing laboratories do not offer this specific test, nor do they possess the infrastructure, expertise, or validated protocols required to achieve the necessary depth and quality for detecting mosaicism and rare genetic variants. Thus, only Baylor's 1000X Exome Sequencing service can satisfy the government's needs for high-quality, comprehensive, and clinically relevant genetic data. Only one award will be made as a result of this notice. This will be awarded as a firm-fixed price purchase order. 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 7 days of this notice. The statutory authority for this sole source requirement is 41 U.S.C. 253(c)(1) as implemented by FAR 6.302-1 (b)(1)(i) only one source available, no substitutions possible. THIS IS NOT A SOLICITATION FOR COMPETITIVE QUOTATIONS. All responsible sources who can provide the 1000X Exome Sequencing test - NSX_WES_Hybs16plex_Seq8plex Samples, Quantity 336 Samples should submit a capability statement via email to Linda Smith at Linda.Smith2@nih.gov. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Any responses received by NIAID after this date and exact time specified are late and will not be considered. 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 it is 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 Linda Smith, Contract Specialist at Linda.smith2@nih.gov.