Q301--Intent to Sole Source Cytopathology and Thyrosequence Testing

The Department of Veterans Affairs, Veterans Integrated Service Network 2, issued an intent to sole source an IDIQ contract for cytopathology and thyroid nodule molecular diagnostic testing services to CYTOPATH BIOPSY LAB INC., with expressions of interest due by June 24, 2026, at 10:00 AM EST. Northport Veterans Affairs Medical Center requires specialized cytopathology services and comprehensive molecular testing to evaluate thyroid nodules with indeterminate cytology, specifically Atypia of Undetermined Significance (AUS) and Follicular Lesion of Undetermined Significance (FLUS) categories. The clinical scope includes 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 risk classifier. The facility currently uses the ThyroSeq Genomic Classifier, a proprietary 112-gene DNA/RNA genomic classifier; the Government states that no alternative test meets minimum requirements for compatibility with existing Veteran molecular records or seamless integration into the established diagnostic workflow. However, interested vendors may submit capability statements demonstrating ability to provide integrated cytopathology and reflex molecular NGS covering DNA and RNA sequencing, deliver comparable results to ThyroSeq data, and meet required turnaround times and clinical performance thresholds. The contract period runs October 1, 2026, through September 30, 2027, with four provisional option years. Responses must be emailed to Mariangie.Rivera@va.gov. This notice does not commit the Government to a contract award and will not reimburse response preparation costs.