An updated timeline for the Next Generation Diagnostics System (NGDS) acquisition program was announced by the U.S. Army last week, shifting the estimated release of a formal Request for Proposals (RFP) to sometime within the next 20 days.
The NGDS effort, spearheaded by the Joint Project Manager for Chemical Biological Medical Systems (JPM CBMS), is intended to develop, test and field a portable human diagnostic system for Chemical, Biological, Radiological, and Nuclear (CBRN) threats and emerging threats of concern. Such a deployable component system is intended to eventually replace and improve upon the current Joint Biological Agent Identification and Diagnostic System (JBAIDS).
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 contract 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 period of approximately nine months 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 is W911QY-12-R-0021. The government anticipates proposals will be due 45 days after the RFP is released. Notes and supporting materials from the NGDS Industry Day held in April are available at the Natick Contracting Division website.