Next Generation Diagnostics System Increment 1

Added: Jul 20, 2012 11:21 am This synopsis is being posted to both the Federal Business Opportunities (FBO) page located at http://www.fbo.gov and the Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division (ACC-APG NCD) site located at http://www3.natick.army.mil/NGDS.html. While it is understood that FBO is a single point of entry for posting of synopsis and solicitations to the internet, NCD is the alternative in case FBO is unavailable. Please feel free to use either site to access the information posted by the ACC-APG NCD.

The ACC-APG NCD on behalf of the Joint Project Manager for Chemical Biological Medical Systems (JPM CBMS) under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD) intends to release a solicitation to procure, on a full and open competitive basis, the Next Generation Diagnostics System (NGDS) Increment 1 Deployable Component system, system consumables, U.S. Food and Drug Administration (FDA) cleared biological warfare agent (BWA), other infectious disease and Chemical Biological Radiological and Nuclear (CBRN) threat in vitro diagnostic (IVD) assays, BWA and non-BWA environmental assays, and contractor logistics support. The NGDS Increment 1 Deployable Component candidates selected for initial award must either be currently under clinical evaluation as an IVD for the U.S. market (clinical trial); 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 CBRN warfare threat diagnostics at the time of fielding. Required CBRN threat assays not available at the time of selection will be developed under this contract. NGDS Increment 1 is anticipated to be, a portable, reusable, adaptable analytical system for preparing and processing human clinical samples (e.g., blood, sputum, stool, urine, etc.). At a minimum, the fielded system will be suitable for use at field microbiology laboratories (land-based Army, Air Force and Navy Role deployable medical treatment facilities, including shipboard environments).

The Government anticipates that three contracts, incorporating a combination of firm fixed price and cost type Indefinite Delivery/Indefinite Quantity (IDIQ) CLINs, 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 TD Phase to FDA clearance. 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 for the contract will be $600,000.00, and the cumulative total of all delivery orders awarded to all awardees will not exceed $240,000,000.00 over the life of the contract.
NAICS Code 334516 - Analytical Laboratory Instrument Manufacturing with a small business size standard of 500 Employees will apply.

The Request for Proposals (RFP) will be released on 20 July 2012, and proposals will be due 45 days after the RFP is released. The solicitation number is W911QY-12-R-0021.

Offerors must be registered in the Central Contractor Registry (CCR). Offeror may obtain information on registration in the CCR by calling 1-888-227-2423, or via the Internet at https://www.ccr.gov.

The Contract Specialists responsible for this action are Mr. John Conlin and Ms. Yvette M. Daltorio. Please direct any questions regarding this announcement to Mr. John Conlin, by email at John.Conlin3.civ@mail.mil or Ms. Yvette M. Daltorio, by email at yvette.m.daltorio.ctr@mail.mil.