B504--Genomic Sequencing Classifier CPT INTENT TO SOLE SOURCE

Good day, SDVOSB s, VOSB s & SB's- INTENT TO SOLE SOURCE This Sources Sought is issued solely for informational and planning purposes only.  It does not constitute the issuance of a solicitation or a promise to issue an solicitation in the future. The purpose of this notice is to conduct market research and obtain information from qualified SBs. This is not a request for bids, quotes, offers, or proposals. The responses to this announcement will assist in determining the socio-economic status such as a SDVOSB set-aside if feasible.  If insufficient SDVOSB responses are received to establish the basis for setting this requirement aside for SDVOSB s, the requirement may be solicited as a VOSB or a SB set aside, if no or not enough small business responses are received, this may be solicited as unrestricted, all interested parties responding shall be eligible to compete. Please direct reply in the affirmative via email if you are interested and can provide the required product/service for this requirement. Please provide your capability statement, letter of supply if applicable or available.  I will accept responses for this Sources Sought until the 15th of June 2026 14:00, thanks. General: C.W. Bill Young Veterans Medical Center is seeking Genomic Sequencing Classifier (GSC) testing for thyroid cancer patients. This test is used to determine treatment plan for thyroid cancer patients in a prognostic, predictive, comprehensive, individualized risk assessment. Afirma GSC is proven to detect medullary thyroid cancer a rare, but aggressive, form of the disease.
These procedures require the services of an outside/reference laboratory to provide comprehensive, individualized risk assessments with results provided in a quantitative score, based on a continuous scale from 0-100. 2.Objective: The reference laboratory shall provide technical and professional services for performance and interpretation of the genomic-based testing for our thyroid cancer patients. The test will deliver critical genomic information to guide treatment decisions. In addition to GSC, Xpression Atlas (XA) provide physicians with a comprehensive solution for a complex landscape in thyroid cancer diagnosis and individualization of care. The combined offering enables physicians to answer multiple clinical questions for their thyroid patients using a single, minimally invasive fine needle aspiration (FNA) sample. 3.Scope: The VAHCS requires the reference laboratory to have the capability to perform and interpret the following list of tests on thyroid biopsies: Afirma FNA - CPT Code 81546 TERT DNA - CPT 81345
4.Reference Laboratory BAA: A signed VHA HIPPA Business Associate Agreement (BAA) is not required from reference laboratories for appropriate security and privacy handling of PHI-patient health information and identity. Reference Laboratories are considered continuity of care. Tasks: The Reference Laboratory must: Be a CLIA licensed/approved laboratory Provide Bay Pines VAHCS a copy of licensure upon request Provide preprinted order form Call all critical results to provider Provide a written descriptive, professional report to include comments that reflect clinical application.