The U.S. Army has issued a Request for Proposals under the Next Generation Diagnostics System (NGDS) acquisition program for development and fielding of a portable human diagnostic system for Chemical, Biological, Radiological, and Nuclear (CBRN) threats and emerging threats of concern.
The NGDS effort, spearheaded by the Joint Project Manager for Chemical Biological Medical Systems (JPM CBMS), is intended to eventually replace and improve upon the current Joint Biological Agent Identification and Diagnostic System (JBAIDS). Required CBRN threat assays not available at the time of selection will be developed under this contract. Any fielded system must be suitable for use at military field microbiology laboratories, including shipboard environments.
The government anticipates that three contracts will be awarded for the procurement for the competitive prototyping stage requirements. Upon completion of the competitive prototyping stage, the Government anticipates conducting a ‘down select’ which will result in one award taking the contractor through the remainder of the development phases to FDA clearance.
The NGDS candidates selected for initial award must either be currently under clinical evaluation as an in vitro device (IVD) for the U.S. market; be cleared via a 510(k) or Premarket Approval (PMA) by the FDA as an IVD or submitted for clearance or approval; or have received approval by the European Medicines Agency (EMA) as an IVD. The contractual intent is to for the system to be FDA cleared for threat diagnostics at the time of fielding.
The contract is anticipated to be a 10-year effort with a base year and nine one year option periods. The guaranteed minimum order will be the negotiated value of the first delivery order, and the cumulative total of all delivery orders awarded to all awardees will not exceed $250,000,000.00 over the life of the contract.
Full details are available under Solicitation Number: W911QY-12-R-0021. The response deadline is September 4, 2012.