Q301--Cytopathology and Thyrosequence Testing Service

NOTICE OF INTENT. The Department of Veterans Affairs, Network Contracting Office 2 intends to solicit and award a sole-source, firm-fixed-price, Indefinite Delivery Contract (with individual task orders issued for the annual ordering periods) with Cytopath Biopsy Lab, Inc. (760 Westchester Ave., Rye Brook, NY 10573-1341) in accordance with 41 U.S.C. 1901, as implemented by FAR 13.106(b)(2)(i): Only one responsible source and no other supplies or services will satisfy agency requirements. The contract anticipated effective date is October 1, 2021 for one year with four option years. This contract is for Cytopathology & Thyrosequence Testing Service. Contractor shall provide for the Northport VA Medical Center (79 Middleville Rd., Northport, NY 11768) approximately 96 tests per year. Patient samples obtained through fine needle aspirate (FNA) biopsies are collected for both cytopathology assessment and ThyroSeq GC. Initially cytopathology assessment is conducted. If the cytopathology diagnosis is benign, suspicious for malignancy, malignant or non-diagnostic, the Cytopathology FNA Analysis is complete. If the cytopathology diagnosis is indeterminate [includes Follicular lesion of Undetermined Significance (FLUS)/Atypia of Undetermined significance (AUS) and (suspicious for) Hurthle/Follicular Neoplasm], the thyroid nodule is greater than or equal to 1 cm and the patient is 21 or older, The ThyroSeq GC Next Generation gene sequencing is performed. ThyroSeq Genomic Classifier (GC) test utilizes next-generation sequencing to analyze DNA and RNA of 112 thyroid-related genes for four main classes of molecular alterations, including mutations, gene fusions, copy number alterations, and gene expression alterations. The results are processed by a unique Genomic Classifier (GC) and reported as Positive or Negative. The NAICS code is 621511 (Medical Laboratories) with a small business size standard of $35 Million. This is for informational purposes only and is not be construed as a commitment by the Government. This is not a request for offers. A determination by the Government not to compete this procurement based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct future competitive procurements for this item. Point of Contact is Brad Mills, Contracting Officer, at email William.Mills4@va.gov, phone 914.737.4400 x202074.