Notice of Intent 75N98026Q01002.pdf

Notice of Intent to Sole Source

Solicitation Number: 75N98026Q01002 Solicitation Type: Sole Source (Non-Competitive) Title: Clinical Division Genetic Testing and

Next Generation Sequencing Services for Active Clinical Protocols- bone marrow failure syndromes, aplastic anemia, myeloid neoplasms, clonal hematopoiesis, and related hematologic disorders

NAICS / Size Standard: 622110/ $47M

Introduction

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO

AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN

COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to The University of Chicago Medical Center to provide Clinical Division Genetic Testing and Next Generation Sequencing

Services for Active Clinical Protocols- bone marrow failure syndromes, aplastic anemia, myeloid neoplasms, clonal hematopoiesis, and related hematologic disorders to the Division of Intramural

Research in accordance with the following information.

Background Information

The Division of Intramural Research (DIR) of the NHLBI maintains a robust clinical program dedicated to advancing the detection, diagnosis, and treatment of cardiovascular, pulmonary, and hematologic diseases. By bridging intensive patient studies with basic bench research, the DIR oversees a diverse portfolio of more than 160 active clinical protocols that translate scientific discoveries into public health solutions. Because accurate identification of inherited genetic mutations is critical for patient management, family counseling, and research, these efforts rely heavily on specialized testing. The

Clinical Division requires ongoing access to specialized clinical laboratory services capable of performing comprehensive germline genetic analysis on patient specimens.

Purpose and Objectives

The purpose of this acquisition is to perform comprehensive germline genetic testing using validated Next

Generation Sequencing methodologies for the detection and characterization of inherited genetic variants associated with bone marrow failure syndromes, aplastic anemia, myeloid neoplasms, clonal hematopoiesis, and related hematologic disorders. The results will provide Clinical Division investigators with access to a clinically validated sequencing panel that evaluates genes known to be associated with inherited bone marrow failure and hematologic disease predisposition syndromes.

Contractor Requirements

The Contractor shall provide a validated Next Generation Sequencing assay capable of analyzing approximately 111 genes known to be associated with hematologic malignancies, inherited bone marrow failure syndromes, and related disorders. At a minimum the assay shall include:

• Complete sequence analysis of coding regions of genes included in the testing panel.

• Analysis of the 5' untranslated regions (UTRs) of ANKRD26, DKC1, TERC, and TERT.

• Analysis of clinically relevant pathogenic variants in GATA2 and other genes included within the validated panel.

• Coverage of all coding exons and applicable flanking intronic sequences necessary for variant detection.

• Target enrichment utilizing validated capture technologies and custom probes, as required.

• DNA sequencing performed using Illumina or equivalent next-generation sequencing technology with paired-end sequencing capability.

• Alignment and analysis using validated bioinformatics pipelines and reference genome standards.

• Supplemental Sanger sequencing or equivalent orthogonal confirmation methods to resolve regions of poor coverage and to confirm pathogenic and likely pathogenic variants.

• Generation of clinical reports identifying pathogenic, likely pathogenic, and other clinically significant variants in accordance with accepted clinical laboratory standards.

Sole Source Justification

The Clinical Division at the National Heart, Lung, and Blood Institute (NHLBI), is responsible for the evaluation and management of patients assigned to active clinical protocols. The requested sequencing results are critical for guiding clinical decision‑making, including selection of appropriate bone marrow transplant donors and determining eligibility for immunosuppressive therapy, which are foundational to the safety of patients and the integrity of the clinical trials being conducted. The University of Chicago provides a clinically validated sequencing panel covering 111 genes uniquely implicated in bone marrow failure syndromes.

The University of Chicago has served as the exclusive laboratory of record for this clinical program throughout ongoing clinical trials. Procuring these services from any other source would introduce severe, unmitigated risks to both patient safety and federal research. The University of Chicago is the only institution that can provide the required gene panel at the specified level of comprehensiveness.

Transitioning to a new laboratory introduces technical variance and differing variant-calling algorithms that, in the high-stakes environment of bone marrow failure syndromes, could lead to misdiagnosis, inappropriate donor selection, or delayed life-saving interventions, thereby directly threatening patient safety. Furthermore, because these ongoing clinical trials rely on continuous, standardized longitudinal data gathered over years, introducing a new testing platform with a different proprietary assay design would create insuperable analytic variance where new data could not be reliably compared to historical baselines, effectively invalidating years of accumulated clinical research and rendering prior phases of the study scientifically useless. The University of Chicago is the only vendor capable of delivering the required 111-gene panel with the necessary comprehensiveness, analytical continuity, and clinical validation to avoid unacceptable scientific risk, protocol failure, and potential harm to human subjects.

Regulatory Authority

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart

12.102 (a), restricting competition. For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available.

FAR Clauses

The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Products and Commercial

Services, applies to this acquisition.

The provision at FAR clause 52.212-2, Evaluation – Commercial Products and Commercial Services, is applicable. The Government will award a contract resulting from this notice to the offeror listed above.

The following factors shall be used to evaluate the offer: The contractor shall demonstrate its ability to provide the services listed that meets the specifications provided above.

FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award

Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

FAR clause at 52.204-13 System for Award Management Maintenance, applies to this acquisition.

The provisions at FAR clause 52.203-17, Contractor Employee Whistleblower Rights, applies to this acquisition.

The provisions at FAR clause 52.222-41, Service Contract Labor Standards, applies to this acquisition.

The provision at FAR clause 52.225-25, Prohibition on Contracting With Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications, applies to this acquisition.

FAR clause FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, applies to this acquisition.

HHSAR clause 352.239-78, Information and Communication Technology Accessibility Notice

HHSAR clause 352.239-79, Information and Communication Technology Accessibility

HHSAR clause 352.232-71, Electronic Submission of Payment Requests

Additional Information

The North American Industry Classification System (NAICS) Code is 622110 and the Small Business Size

Standard is $47M. This acquisition is being conducted under RFO FAR Part 12, Acquisition of

Commercial Products and Commercial Services, therefore the requirements of FAR Part 6, Competitive

Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01 effective March 13, 2026.

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier

(UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

All responses must be received by September 08, 2026, at 12:00PM ED and must reference synopsis number 75N98026Q01002. Responses shall be submitted electronically to noelle.decenzo@nih.gov.

Responses will only be accepted if dated and signed by an authorized company representative. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

http://www.sam.gov/ mailto:noelle.decenzo@nih.gov