65--Request for Info./Notice of Intent to Sole Source for Hologic Aptima HIV-1/ HCV RNA Qualtitative and Hologic Aptima Combo 2 test kits.

This notice announces the intent by the U.S. Army Medical Acquisition Activity (USAMRAA), 820 Chandler St, Fort Detrick, Maryland, 21702, intends to award a sole source contract to Hologic, Inc. for FDA-cleared Molecular test kits from Hologics, Inc. to include: Aptima HIV-1 RNA Qualitative, Aptima HCV RNA Qualitative and Aptima Combo2 (Panther) test kits in support of HIV-1 diagnosis for the WRAIR HIV Diagnostics and Reference Laboratory (HDRL). The proposed contract action is for supplies for which the government intends to solicit and negotiate with only one source under the statutory authority 10 U.S.C. 2304 (c)(2). The FAR citation is 6.302-1(a)(2)(iii), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The primary mission of the WRAIR HIV Diagnostics and Reference Laboratory (HDRL), US Military HIV Research Program, WRAIR is to provide HIV screening and supplemental confirmatory testing for US Army and US Military Entrance Processing Command (MEPCOM) accession candidates, US Army Soldiers and their Beneficiaries, and our sister services; the US Navy and US Air Force including Dover Air Base, Armed Medical Examiner System, upon request. HDRL serves as the DoD Reference Laboratory for HIV-1 Diagnosis. A second mission is to provide molecular testing services for detection of the Human Immunodeficiency Virus (HIV) for confirmation of the diagnosis of HIV-1 and for monitoring of HIV-1 viral load, HCV viral load (upon request) and HIV-1 Genotype Resistance in HIV-1 infected US Army Soldiers and Beneficiaries to allow clinicians to provide appropriate treatment decisions. The Hologic Aptima HIV-1/ HCV RNA Qualtitative Test Kits along with assay specific instrumentation is the only FDA-approved, commercially available assay of its kind in the marketplace. MEDCOM and the DoD require use of a FDA cleared test if available. No other such assay is available. Likewise, the Hologic Aptima Combo 2 test kit is the only FDA-cleared Chlamydia/Gonorrhea test kit that can be performed on the Panther Instrument System, DX. No other FDA cleared assay can be performed on the Panther instrument owned and validated in the lab. An RFQ will be issued on a sole source basis. The North American Industry Classification System (NAICS) for this requirement is 325413 and the size standard is 500 employees. This announcement fulfills the synopsis requirements under FAR 5.102(a)(6) and 5.203(a). USAMRAA intends to publish a solicitation no sooner than 15 days after publishing this synopsis. This Special Request for Information is not a request for competitive quotes. Information received in response to this notice will be considered solely for the purpose of determining whether a competitive procurement is in the best interest of the Government. If no written responses are received by the date listed below, which reflects at least fifteen (15) days after the publication of this notice, the solicitation will be issued as sole source. All questions and responses concerning this notice shall be emailed to Ms. Amanda Best at [email protected]. Interested concerns must identify their capability to the above email address no later than 2:00 PM Eastern Time, 11 June 2015.