Thyroseq V3 molecular testing for fine needle aspiration biopsy samples of thyroid nodules

COMBINED SYNOPSIS / SOLICITATION Title: Thyroseq V3 molecular testing for fine needle aspiration biopsy samples of thyroid nodules This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued. The solicitation number is 75N98026Q00822. This solicitation is issued as a competitive combined synopsis/solicitation for commercial products or commercial services. The Government intends to award a contract or purchase order resulting from this solicitation using full and open competition. This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold of $350,000.00. The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, seeks to award a Firm-Fixed-Price to the responsible offeror whose proposal represents the best value to the Government. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01 March 13, 2026. The associated NAICS code is 621511, and the small business size standard is 41,500,000 employees. This requirement is NOT A SET-ASIDE for small businesses. Description of Requirement: Thyroseq V3 molecular testing for fine needle aspiration biopsy samples of thyroid nodules. BACKGROUND Whenever a thyroid nodule is found in a patient, a fine needle aspiration (FNA) biopsy is performed to check whether the nodule is benign or malignant. A clear classification of a thyroid nodule into benign or malignant helps both the patients and the physicians with determining the next best step regarding the treatment option for the patient. However, a number of nodules (anywhere from 30% - 50% of FNA biopsies) get resulted as ‘indeterminate’ or ‘borderline’ (known as atypia of undetermined significance or Bethesda III or follicular neoplasm or Bethesda IV). The options for management of such nodules until the last decade were either a repeat FNA or a diagnostic thyroid lobectomy. This indeterminate nature of these nodules would cause undue anxiety to the patients and would lead to unnecessary surgeries or repeat procedures as several of these nodules are generally benign and would lead to a lot of preventable expenses for the institute. OBJECTIVE To continue to provide molecular testing for patients with indeterminate thyroid nodules, which is the current standard-of-care for the management of this subset of nodules. CONTRACTOR REQUIREMENTS TASK AREAS: Thyroid nodule testing, up to 20 thyroid nodules The collection, handling, and shipping of the biopsy samples is performed by the cytopathology division of the laboratory of pathology at the NCI. The FNA biopsy of thyroid nodules, determination for testing of the nodules, filling out the requisition forms, and receipt of the reports is done by the NIDDK. The contractor shall send all the requisition forms and sample collection and storage equipment at no additional cost to the NCI cytopathology unit. Contractor shall include a detailed report on the identified mutations and the corresponding risk for malignancy, and the recommended next steps for management for each test. The report shall also include a comprehensive description of all the identified mutations. TASK AREA 1 – delivery timelines: 2 weeks. TASK AREA 2 - shipping instructions – handled by the NCI cytopathology unit. TASK AREA 3 - Installation requirements – None. The tubes and storage boxes are provided by the contractor to the NCI cytopathology unit, and they are stored in a designated refrigerator. The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition. Add any agency-specific instructions as required. The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation represents the best value to the Government, price and other factors considered. Evaluation Criteria The evaluation will be based on the demonstrated capabilities of the prospective Offeror in relation to the needs of the project as set forth in the Statement of Work. The merits of the proposal will be evaluated carefully and will be deemed Acceptable or Unacceptable. The proposal must document the feasibility of successful implementation of the requirements of the Statement of Work. The Offeror must submit information sufficient to evaluate the proposal based on the detailed factors listed below. The Offeror should note that the evaluation criteria listed in order of importance are: Lowest Price Technically Acceptable (LPTA) Service Specifications: Next-generation molecular testing for fine needle aspiration biopsy samples of thyroid nodules, sequencing platform testing for about 110 thyroid cancer-related genes in indeterminate thyroid nodule fine needle aspiration biopsy samples, up to 20 nodules per year.  Evaluation Criteria Acceptable Unacceptable A. Technical The services proposed by the vendor meet(s) the requirements in the SOW Summary Overall Rating (Overall Risk) C. Cost/Price 1. Offerors will be evaluated based upon LPTA. Technical Evaluation Rating Definitions Rating Definition Acceptable Proposal meets requirements and indicates an adequate approach and understanding of the requirements, and risk of unsuccessful performance is no worse than moderate. Unacceptable Proposal does not meet requirements of the solicitation, and thus, contains one or more deficiencies, and/or risk of unsuccessful pe…