--Request for Information for Next Generation Diagnostics (Joint Biological Agent Identification and Diagnostic System Block III) Roadmap Study Investigation 2006

This is a Request for Information (RFI). The Chemical Biological Medical Systems (CBMS) Joint Project Management Office, under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), is issuing a request for information (R FI) to survey available and/or emerging technologies that may be incorporated into a military pathogen identification and diagnostic system to meet the needs of all U.S. DoD military services. This RFI is specifically seeking information on technologies t hat will support delivery of the Next Generation Diagnostics Joint Biological Agent Identification and Diagnostic System (JBAIDS), previously referred as JBAIDS Block III. Information gathered in response to this RFI will be used to support the Medical Identification and Treatment Systems (MITS)-JBAIDS program office in strategic planning for development of a Next Generation Diagnostics JBAIDS acquisition strategy. The Block I JBAIDS has successfully been developed to meet Joint Service requirements wit h fielding initiated in 2005. Block I is a polymerase chain reaction (PCR)-based system that includes assays for 16 targets representing 14 different biological warfare (BW) pathogens; JBAIDS assays have demonstrated greater than 95% sensitivity at the 90 % confidence level in a variety of both environmental and clinical matrices with specificity greater than 90% against genetic near neighbors. The Next Generation Diagnostics JBAIDS is envisioned to employ, in a system-of-systems design approach, a combina tion of nucleic acid detection and non-nucleic acid detection (not limited to conventional methods), supplemented by an automated (or semi-automated) sample preparation component. This next generation system will be modular in design and will likely depen d on a fusion of protein (or other molecular target) and nucleic acid detection results; ideas or technologies addressing this approach are solicited. This RFI seeks submissions that will provide contributions to any or all of the following components of the next generation system: nucleic acid detection, non-nucleic acid detection (proteins/other molecular targets), automated sample preparation, data-fusion, and a communication subsystem module to allow system connectivity to DoD medical/ information repo rting systems and into the DoD Global Information Grid (GIG). Responders are encouraged to clearly specify which modular subsystem component(s) will be addressed in their technology submissions. A detailed system specification is beyond the scope of this RFI and only the fundamental technology needs will be highlighted within this document. The desired system-of-systems will perform simultaneous orthogonal identification of multiple pathogens and toxins in both clinical and environmental samples with spe cificity of greater than or equal to 95% and achieve levels of threat agent identification (sensitivity) with high fidelity and statistically supported confidence. Capability is desired to test both clinical specimens and environmental samples for a broad spectrum (e.g. up to 50) of agents and pathogens. An evolutionary development and fielding approach is envisioned with the initial fielded Next Generation Diagnostics JBAIDS being capable of meeting or exceeding the capabilities of the JBAIDS Block I sy stem described above and adding capability to identify a minimum of 5 toxins in both environmental and clinical samples. The envisioned next generation system will require little or no ancillary sample prep support equipment. Manufacturing of this system and associated assay kits, if required, must be cGMP compliant as the Next Generation Diagnostics JBAIDS will be required to obtain FDA approval as a clinical diagnostic device. After initial fielding, the Next Generation Diagnostics JBAIDS capability wi ll be incrementally increased by adding additional BW agents and toxin identification capabilities. Minimal logistics and personnel support is desired for oper ation of the Next Generation Diagnostics JBAIDS. Capability of the system to operate using reagent-less systems, or minimal or no fluidics, is highly desirable. Sample preparation, if required, must be automated and integrated within the system. The sys tem must be able to be successfully operated by personnel with limited training and technical skill sets. The final design must be small (objective: 20 lbs or less, briefcase size or smaller), easily transportable, and ruggedized). The Next Generation Dia gnostics JBAIDS must have onboard software that is capable of device operation, output analysis, and information transfer using conventional methods (such as ethernet or serial communication) which can interface with existing DoD medical/information report ing systems and the DoD GIG. The envisioned operational use is far forward in the battle space. In contrast to prior RFIs and solicitations from the MITS-JBAIDS program office, this RFI is not necessarily targeted at commercial off-the-shelf systems. Co mpanies with technologies/systems/subsystems under development in the prototype/brassboard stage are encouraged to respond to this RFI. Early developmental efforts will be considered. Additionally, companies that have developed technologies/subsystems th at can serve as partial solutions to an integrated JBAIDS next generation platform are also encouraged to respond to this RFI. The desired development time frame would be for the subsystem to achieve a technology readiness level (TRL) of 4-5 or higher to support a Government acquisition concept refinement effort (Milestone A) into a functional brassboard device in 2 years (2008). However, information on the level of development achievable at both the 2-year and 5-year time frame is desired. JPEO-CBD defi nitions for TRLs are available upon request by contacting the MITS-JBAIDS program office as noted below. The following information is requested from prospective companies electing to respond to this RFI: 1) Notification in writing to the Government  comp any POC and address; 2) a written statement (3-5 pages maximum) describing the company's ability to provide a Next Generation Diagnostics JBAIDS subsystem or subsystems (nucleic acid detection, protein detection, sample preparation, data-fusion, and commu nication module). Companies interested in this RFI are also asked to use a quad chart (available upon request) as a summary template for initial responses back to the Government. Companies are encouraged to additionally provide brief technology developme ntal plans for how their proposed Next Generation Diagnostics JBAIDS subsystem will be matured over the next 2-4 years to include making their proposed subsystems smaller in physical size. Also, the Government is interested in any companys strategic part nerships or cooperative research and developmental areas the candidate technology may leverage in the developmental process. The Government may request meetings with the candidates to provide more in-depth technical briefings as necessary to complete the survey. Responses to this RFI will be accepted for review if received by 30 November 2006 by 4:00PM EST. Responding companies also need to state that their company is eligible to receive a DoD Secret-Level Clearance. Companies desiring to participate in this RFI notice effort should contact Dr. James Karaszkiewicz for a copy of the JPEO-CBD Assigning Technology Readiness Levels reference document and the summary quad chart. Dr. Karaszkiewiczs e-mail address is contact@example.gov in Frederick MD, phone: +1 (555) 000-0000; and mailing address: JPM CBMS, Attn: SFAE-CBD-CBMS-MITS/Dr. James Karaszkiewicz, 64 Thomas Johnson Dr., Frederick MD 21702. The CBMS-MITS-JBAIDS referenced material will be e-mailed to requesting companies. This notice is being released by the US Army Space and Missile Defense Command, Attn: Susan Dell (contact@example.gov), Contract Specialist, 64 Thomas Johnson Dri ve, Frederick MD 21702. Written responses to this RFI notice must be forwarded to Ms. Dell and Dr. Karaszkiewicz via e-mail and hardcopy to the above mentioned mailing addresses. The Government makes no future guarantees of a request for proposal release on a Next Generation Diagnostics JBAIDS (Block III) development effort. The above technical material responses from companies will be used in developing a DoD BW medical diagnostic equipment roadmap for future DoD investment strategies. This RFI is issu ed solely for information and planning purposes only and does not constitute a solicitation or issuance thereof. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to this RFI will not be re turned. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.