FDA Cleared External Control Kits

Added: Feb 23, 2017 4:48 pm The U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, on behalf of The Joint Project Management Office for Medical Countermeasure Systems - Joint Product Management Office for Diagnostics, intends to award a sole source firm fixed price contract for the acquisition of FDA cleared external control kits for use with a BWA Assay developed under the Next Generation Diagnostic System (NGDS) Increment 1 program. This contract will be awarded under the authority of Federal Acquisition Regulation (FAR) Subpart 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The contract will be established for a one (1) year base period with three (3) one year option periods. The Government intends to negotiate on a sole source basis with Maine Molecular Quality Controls, Inc. (MMQCI) operating as a Small Business located in Saco, ME.

The NGDS FilmArray® system and the related assays developed under the NGDS Increment 1 program are FDA Cleared items. As such the FDA requires an approved external/quality control test for use with the NGDS Inc 1 BWA in vitro diagnostic (IVD) panel. In order to meet this FDA requirement, the NGDS Increment 1 BWA IVD panel external/quality controls (Positive & Negative Control Vials) were developed by MMQCI specifically for the NGDS Increment 1 program. The information required to develop and produce the IVD panel external/quality controls is sensitive information and not available to the medical diagnostic assay industry unless provided through the DoD. MMQCI is the only source that can meet the Governments need for the required FDA approved external/quality control kits.

The North American Industry Classification System (NAICS) code is 325413. The Small Business Size Standard is 1,250 employees. This is not a Small Business Set-Aside. The Government anticipates awarding one (1) contract award. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. This notice is posted for ten (10) business days. No solicitation package will be available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. If no affirmative written response is received by 3:00 pm EST, March 7, 2017, the contract will be issued without further notice. A determination by the Government not to compete this contract is based on this notice and is solely within the discretion of the Government. Any questions shall be made in writing and directed to: Ms. Yvette M Daltorio, Contract Specialist, via email at yvette.m.daltorio.civ@mail.mil.