Intent to Sole Source.pdf
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- Solicitation number
- 36C24227Q0003
About this file
This is a Special Notice of Intent to Award a Sole Source Procurement issued by the Department of Veterans Affairs, Northport VA Medical Center. The Department intends to award an Indefinite Delivery/Indefinite Quantity (IDIQ) contract for thyroid nodule molecular diagnostic testing services to CYTOPATH BIOPSY LAB INC. under FAR 6.103-1 for Only One Responsible Source. The contract is not set-aside and falls under NAICS code 621511 (Medical Laboratories). The Period of Performance runs from October 1, 2026, through September 30, 2027, with four provisional option years. The RFI solicitation number is 36C24227Q0003, with a due date of Wednesday, June 24, 2026, at 10:00 AM EST for Expressions of Interest.
The clinical requirement involves specialized cytopathology services for evaluating thyroid nodules with indeterminate cytology (AUS/FLUS categories), including cytopathology evaluation of fine needle aspiration samples, reflex molecular testing using Next-Generation Sequencing of DNA and RNA, analysis of thyroid-related mutations and alterations, and delivery of a single integrated Positive/Negative risk classifier. The facility currently utilizes ThyroSeq® Genomic Classifier, which provides combined cytopathology and reflex molecular sequencing within a single laboratory ecosystem using a proprietary 112-gene DNA/RNA genomic classifier. The notice states that no alternative test meets the minimum requirements for compatibility with existing Veteran molecular records or seamless integration into the established diagnostic workflow, as alternative platforms would produce non-comparable results. However, interested vendors may submit capability statements demonstrating their ability to provide integrated cytopathology and reflex molecular NGS, perform DNA and RNA sequencing covering mutations, fusions, copy number alterations, and expression alterations, deliver comparable results to ThyroSeq® data, and meet required turnaround times and clinical performance thresholds. All responses must be emailed to Mariangie.Rivera@va.gov by the deadline. The notice does not constitute a solicitation, does not commit the Government to a contract award, and will not reimburse response preparation costs. No telephone inquiries are accepted.
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TITLE: SPECIAL NOTICE OF INTENT TO AWARD A SOLE SOURCE PROCUREMENT
RFI SOL: 36C24227Q0003
DUE: Wednesday June 24, 2026, at 10:00 AM EST.
SET ASIDE: Not Set-Aside
NAICS: 621511 – Medical Laboratories
POP: 10/01/2026 – 09/30/2027 + four provisional option years
AGENCY: Department of Veterans Affairs NCO 2 Samuel S. Stratton Albany, NY 12208
POC: Mariangie Rivera, email Mariangie.Rivera@va.gov
SPECIAL NOTICE OF INTENT TO AWARD A SOLE SOURCE PROCUREMENT
The Department of Veterans Affairs, Northport VA Medical Center (79 Middleville Road, Northport, NY) intends to award a sole source, Indefinite Delivery/Indefinite Quantity (IDIQ) contract for thyroid nodule molecular diagnostic testing services to: CYTOPATH BIOPSY LAB INC.
This acquisition will be conducted in accordance with: FAR Overhaul 6.103-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.
This is not a request for competitive proposals.
DESCRIPTION OF REQUIREMENT
Northport Veterans Affairs Medical Center (VAMC) requires specialized cytopathology services with comprehensive testing for the evaluation of thyroid nodules with indeterminate cytology Atypia of Undetermined Significance (AUS)/ Follicular Lesion of Undetermined Significance (FLUS) and related categories.
The clinical requirement includes:
• Cytopathology evaluation of fine needle aspiration (FNA) samples
• Reflex molecular testing only when cytopathology is indeterminate
• Next‑Generation Sequencing (NGS) of DNA and RNA from thyroid nodule FNA material
• Analysis of thyroid‑related mutations, gene fusions, copy number alterations, and expression alterations
• Delivery of a single integrated Positive/Negative risk classifier compatible with current clinical management pathways used by Northport VAMC endocrinology and pathology
• Compatibility with existing Veterans’ historical molecular results
The facility currently utilizes the proprietary testing of ThyroSeq® Genomic Classifier (GC) as part of established diagnostic workflow and longitudinal patient management. ThyroSeq® platform provides the mailto:Mariangie.Rivera@va.gov combined cytopathology + reflex molecular sequencing performed within the same laboratory ecosystem and the proprietary 112‑gene DNA/RNA genomic classifier required for clinical comparability with prior Veteran test results.
No alternative test meets the Northport VAMC’s minimum requirements for compatibility with existing Veteran molecular records or seamless integration into the established Pathology & Laboratory Medicine Service (PALMS) diagnostic workflow. Use of a different testing platform would produce non‑comparable results due to differing gene panels, classifier algorithms, and reporting structures, which in turn would introduce diagnostic variability and increase clinical risk. Only the ThyroSeq® Genomic Classifier provides results consistent with the facility’s current clinical pathways and historical patient data.
Based on clinical validation, workflow integration, and the need for result continuity, the ThyroSeq® GC test is uniquely capable of meeting Northport VAMC’s minimum requirements.
However, interested parties may identify their interest and capability to respond to this requirement.
Interested vendors may submit a capability statement demonstrating their ability to:
• Provide integrated cytopathology and reflex molecular NGS in a single laboratory workflow
• Perform DNA and RNA sequencing of thyroid nodules covering mutation, fusion, CNA, and expression alterations
• Deliver results comparable to existing ThyroSeq® data to maintain continuity of care
• Meet required turnaround times and clinical performance thresholds
Capabilities that do not meet the agency’s minimum requirements will not be considered.
The Government MAY consider all Expressions of Interest (EOI) received prior to Wednesday June 24, 2026, by 10:00 AM EST.
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.
This Special Notice is issued solely for information and planning purposes. It does not constitute a solicitation or promise to issue a solicitation in the future. The Government will not reimburse costs associated with preparing or submitting responses to this notice.
All responses to this notice must be emailed to Mariangie.Rivera@va.gov and it must be received no later than Wednesday June 24, 2026, at 10:00 AM EST. This notice does not commit the Government to a contract award, nor does it guarantee any additional information will be provided.
No telephone inquiries will be accepted.
mailto:Mariangie.Rivera@va.gov
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