PRE-SOLICITATION NOTICE ** NOTICE OF INTENT

NOI-NIAID-23-2180562

NAICS – 541380, Testing Laboratories

This 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 Baylor Miraca Genetics Laboratories, LLC to procure continued chromosomal microarray analysis – HR + SNP screen (comprehensive) services for the NIAID Centralized Sequencing Program located in Bethesda, MD.

The 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 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.

1. PURPOSE AND OBJECTIVES OF THE ACQUISITION

The purpose of this acquisition is to support the mission of DIR to obtain genetic testing for the NIAID Centralized Sequencing Initiative. The objective is to purchase microarrays that will be coupled with whole genome sequencing, and RNAseq. The centralized sequencing initiative will have direct implications for the care of NIH patients and for the discovery of disease mechanisms.

The types of sequencing required for the initiative are: custom microarrays for Comparative Genomic Hybridization (CGH), SNP microarrays, Whole Genome Sequencing (WGS) and RNAseq. Genome sequencing allows for discovery of monogenic and polygenic contributions to disease. Microarrays will provide clinical analysis of copy number variants contributing to those diseases. CGH microarray sequencing will provide analysis of over 2000 target genes selected by NIAID that cause, or are suspected to cause, immunological diseases in the patient population. This specific acquisition focuses on the microarrays.

1. CONTRACTOR REQUIREMENTS:

• Clinical SNP and/or CGH microarray with targeted coverage of neuropsychiatric phenotypes (N = 16)
  • • Sample processing and microarray scanning.
    • Feature extraction: Processing of raw image files.
    • CNV calls: Use of the vendor’s genetics pipeline for making copy-number calls from the microarray data.
    • Report: Data review by the vendor’s Genetics team with input from NIAID team for determination of which copy-number calls should be reported clinically. Generation of a report for use by the NIAID team.
    • Web-based access to cases and database: Online access for members of the NIAID team to the vendor database of prior results. This is useful for interpretation and clinical reporting.
    • Data release of raw image files and any intermediate files upon request.

1. CONTRACTOR SUPPLIED MATERIALS

The Contractor shall provide plates for shipping and all consumable reagents except those mentioned below.

1. GOVERNMENT FURNISHED MATERIALS

NIAID will supply patient samples. NIAID will also supply microarray chips for the NIAID custom clinical chromosomal microarray analysis.

1. REPORTING REQUIREMENTS AND DELIVERABLES FOR CLINICAL WHOLE GENOME SEQUENCING:

• Turn-around time for microarrays is 2 weeks from the time the contractor receives the patient sample.
• Report: Data review by the vendor’s Genetics team with input from NIAID team for determination of which copy-number calls should be reported clinically. Generation of a report for use by the NIAID team.
• Web-based access to cases and database: Online access for members of the NIAID team to the vendor database of prior results. This is useful for interpretation and clinical reporting.
• Data release of raw image files and any intermediate files upon request.

1. INSPECTION AND ACCEPTANCE

All deliverables will be inspected by the project manager, an employee of the Division of Intramural Research. Acceptance will occur when results are successfully transferred to NIH per the specifications and format outline in the requirements above.

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 along with documentation proving they can provide the required services listed herein; this will be considered by email (subject line to reference NOI-NIAID-23-2180562 to Dana Monroe at [email protected] by 5:00pm EDST Wednesday, July 5, 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.