Hologic Panther Analyzer HPV Testing Supplies

The Defense Health Agency (DHA) Southeast Contracting Division intends to negotiate a modification to a contract on a sole source basis (IAW FAR 13.501(a) sole source acquisitions). The proposed source is Hologic Sales and Service, LLC; Cage Code: 5JP89 located at 250 Campus Drive Marlborough, MA 01752.It is the contractor’s responsibility to be familiar with the applicable FAR and DFARS clauses and provisions. The FAR and DFARS clauses may be accessed in full text at the below-referenced addresses:FAR Clauses: http://acquisition.gov/browsefarDFARS Clauses: https://www.acq.osd.mil/dpap/dars/dfarspgi/current/The requirement is supplies for HPV testing to operate specifically on the Hologic Panther Analyzer. The item numbers consist of PRD-303570, Aptima HPV Assay (100 test), PRD-303236 Aptima HPV 16

18/45 Genotype Assay (100 test), PRD-301154CAptima Specimen Transfer Kit (LPT) which are required for HPV real-time testing on the existing Hologic Panther analyzer. Hologic is identified as the only company to provide HPV test supplies that are required for utilization on the Panther Analyzer. The Assay test reagents, transfer kits are required to perform patient testing on the Hologic Panther analyzer. The Aptima assays have been validated for use with the Panther system. The firmware in the Panther system is necessary for running the Aptima assays and is unique to Hologic. The kits and reagents were developed and qualified to be used with the Aptima assays and may include proprietary technology.There are no set-aside restrictions for this requirement. The intended procurement will be classified under North America Industry Classification System (NAICS) 325413-In-Vitro Diagnostic Substance Manufacturing. This notice of intent is not a request for competitive proposals and no solicitation document exists for this requirement. However, parties interested in responding to this notice will need to submit technical data sufficient to determine capability in providing the same product. All capability statements received by the closing date of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.If a vendor challenges the basis of this requirement, please email product capability statements (formats for submission: PDF, MS Word, or MS Excel) to April Gillespie at april.m.gillespie2.civ@health.mil and Jessica Horst at jessica.l.horst5.civ@health.mil. Closing date for challenges is no later than 03:30 PM ET on 16 November 2023. No phone calls will be accepted.