Intent to Sole Source Cytopathology and Thyrosequence Testing

Summary (Newest Update)

Background The Northport Veterans Affairs Medical Center (VAMC), part of the Department of Veterans Affairs, is seeking to award a sole source contract for specialized cytopathology services. The goal of this contract is to provide comprehensive testing for the evaluation of thyroid nodules with indeterminate cytology, specifically Atypia of Undetermined Significance (AUS) and Follicular Lesion of Undetermined Significance (FLUS). This acquisition is necessary due to the unique requirements that only one responsible source can fulfill, which is CYTOPATH BIOPSY LAB INC. Work Details The contractor will be responsible for the following tasks: - Conducting cytopathology evaluations of fine needle aspiration (FNA) samples. - Performing reflex molecular testing only when cytopathology results are indeterminate. - Executing Next Generation Sequencing (NGS) of DNA and RNA from thyroid nodule FNA material. - Analyzing thyroid-related mutations, gene fusions, copy number alterations, and expression alterations. - Delivering a single integrated Positive/Negative risk classifier that is compatible with current clinical management pathways used by Northport VAMC endocrinology and pathology. - Ensuring compatibility with existing Veterans’ historical molecular results. The facility currently utilizes the proprietary ThyroSeq® Genomic Classifier as part of its established diagnostic workflow. Period of Performance The contract will be performed from October 1, 2026, to September 30, 2027, with four provisional option years. Place of Performance Northport Veterans Affairs Medical Center, 79 Middleville Road, Northport, NY. Bidder Requirements Interested vendors must demonstrate their capability to provide integrated cytopathology and reflex molecular NGS in a single laboratory workflow. They must also be able to perform DNA and RNA sequencing covering mutation, fusion, CNA, and expression alterations while delivering results comparable to existing ThyroSeq® data to maintain continuity of care. Additionally, they must meet required turnaround times and clinical performance thresholds. Incumbent Analysis (see Incumbents section for more detail) The Northport VAMC appears to have a confirmed incumbent for cytopathology and ThyroSeq testing, with Cytopath Biopsy Lab awarded contract 36C24222D0005 (and related option/task order periods) valued at $167,065 for 10/05/21–09/30/26, including subsequent option funding through 09/30/26. The prior work includes cytopathology assessment of thyroid FNA samples with reflex ThyroSeq Genomic Classifier next-generation sequencing for indeterminate AUS/FLUS cases, reporting integrated positive/negative risk results based on DNA/RNA analysis of thyroid-related genes. This closely aligns with the current requirement for specialized cytopathology and reflex molecular NGS for AUS/FLUS thyroid nodules and continuity with existing ThyroSeq-based workflows.