SPECIAL NOTICE
A -- Next Generation Diagnostics System (NGDS) Increment 1
- Notice Date
- 10/20/2010
- Notice Type
- Special Notice
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- US Army Space and Missile Defense Command, Deputy Commander, ATTN SMDC-CM-AP, P.O. Box 1500, Huntsville, AL 35807-3801
- ZIP Code
- 35807-3801
- Solicitation Number
- RDECOM-RFI-NGDS
- Archive Date
- 1/18/2011
- Point of Contact
- Cynthia Gnam, 301-619-8453
- E-Mail Address
-
US Army Space and Missile Defense Command, Deputy Commander
(cynthia.gnam@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- This is a Request for Information (RFI), issued to promote exchanges of information between government and industry, as defined in FAR 15.201. Responses to this notice will NOT be considered an offer and cannot be accepted by the government to form a binding contract. PROGRAM DESCRIPTION: The Chemical Biological Medical Systems Joint Project Management Office (CBMS JPMO), under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), is issuing a RFI to obtain information on Commercial-Off-The-Shelf (COTS) systems that may be applicable to the Next Generation Diagnostic System (NGDS) Increment 1 program. The NGDS Increment 1 rapid acquisition program is intended to provide a complementary identification or diagnostic capability to existing Department of Defense (DoD) Joint Biological Agent Identification and Diagnostic System (JBAIDS) users or an initial capability to the broader DoD human and veterinarian community. The Increment 1 acquisition strategy includes Preplanned Product Improvements (P3I) to the initial capability to add additional U.S. Food and Drug Administration (FDA)-cleared diagnostic assays for Biological Warfare Agents (BWA) (e.g. anthrax and smallpox) threats and emerging infectious diseases over the system's lifecycle. The NGDS will follow an evolutionary acquisition approach to best meet near and long-term goals and to exploit the exponential growth in the biotechnology field. The overall NGDS program is envisioned to be family-of-systems providing modular orthogonal diagnostics capabilities across all operational echelons (tactical, field confirmatory, fixed facilities) and fielded over several acquisition increments. Subsequent NGDS increments will not replace Increment 1 but will expand upon Increment 1 in a modular and/or echeloned approach. NGDS may also include enabling technologies to enhance the screening, collection and transport of clinical samples for diagnostic analysis and back end data analysis and fusion. A broad range of potential materiel solutions may be applicable to NGDS Increment 1: "Diagnostic nucleic acid detection platforms and assays "Diagnostic non-nucleic acid detection platforms and assays "Non-diagnostic platforms and assays for pathogens, toxins and/or biomarkers of chemical, biological or radiological exposure "Automated sample preparation - integrated or standalone "Human and animal non-diagnostic and point-of-care diagnostic field screening tools "Clinical sample preservation, packaging and transport kits "Field analytical support equipment (consumable storage/preservation, sample tracking, work flow aids, contamination control, waste disposal) DESIRED CAPABILITY: Respondents are requested to describe their identification system with respect to the following metrics [desired capabilities]. "Rapid identification of multiple targets for a broad range of pathogens and toxins in clinical and environmental sample matrices (blood, sputum, buffer solution with environmental clutter, surface swabs) "Technical approach used for sample preparation and analysis "List of existing biological pathogen and toxin assays available for platform "Sensitivity and specificity per assay in a given sample matrix "Number of simultaneous samples that can be processed "Number of simultaneous targets that a sample can be screened for "Single sample analysis time (time to process 1 sample from receipt to result, including sample preparation, if any) "Throughput (samples/8 hours) with single operator "Minimal logistics (weight, cube and storage requirements of consumables) "Room temperature stable consumables [18C-28C for greater than 1 year] "Flexible analysis (test 1 sample for many targets or test many samples for few targets) "Minimal operator interaction (minutes of operator time per sample/batch) "Minimal training [less than 2 weeks for laboratory technician skill level] "Communication via Ethernet / USB 2.0 "Power usage "Total footprint (ft2) in operational configuration "Total system weight and cube (ft3) in shipping configuration of system plus all support equipment and consumables needed to process 30 clinical samples (assume power is provided, may be distributed over multiple shipping containers). "Maximum single container weight: 2-person lift/carry for 10 meters in transit/shipping configuration [less than84 lbs. in accordance with Mil-Std-1472F] "Physical shock, vibration and weather resistance in transit/shipping configuration "Need for secondary containment for sample processing - glove box / hood Respondents are requested to address the following in their response: "Availability of COTS hardware, for briefing or demonstration in approximately February 2011. "FDA clearance or pending 510k status for diagnostic systems and assays "Electrical hardware must be UL or ENEC listed "Diagnostic systems must be manufactured in compliance with current good manufacturing practice (cGMP) "System is manufactured in the United States or a have a transition plan for manufacturing by a U.S. subsidiary "Company is eligible to receive a DoD Secret-Level Clearance and is eligible to work with CDC/USDA Select Agents "Corporate ability to rapidly develop new assays for platform "Unit cost, consumable cost per test "Open architecture software / file formats readable without proprietary software "Compatibility electronic patient records / HIPAA "Current commercial applications of system "Intellectual property position, licenses and Government Use Rights "Plans to ensure stability of manufacturing and supply through the year 2022 "Available warranties and service agreements Respondents offering products other than identification platforms (enabling technologies) should provide a system description, discussion of prior use in military or civilian applications and highlight the product's competitive advantages. SCENARIOS: The following scenarios are provided to help prospective respondents to this RFI determine the relevance of their system to the NGDS Inc 1 program. Operational scenarios: "NGDS Increment 1 platforms will be operated in permissive, improved locations with line power, lighting and a stable fixed, mobile, or fly-away laboratory workspace "NGDI Increment 1 platforms may be used in parallel with JBAIDS (requiring sample splitting) to provide tests for additional agents beyond those available with JBAIDS or as an orthogonal test for the same agents as JBAIDS "NGDS Increment 1 platforms may be used as a standalone capability in mobile or fly-away laboratory applications (without JBAIDS) "Screening tools and point of care diagnostic kits may be used in permissive but austere areas by personnel who are collecting clinical samples to be transported to a laboratory. Acquisition scenarios: "Standalone automated sample preparation system to decease the operator time, logistical footprint and per sample cost of the existing JBAIDS "Standalone automated sample preparation and identification components from the same or different vendors that can be qualified for use together as a system by the government "Physically integrated sample preparation and identification system "Enabling technologies that enhance the performance of existing or newly acquired identification platforms or the timeliness of clinical sample collection. SUBMISSION INFORMATION: Information gathered in response to this RFI will be used to support the development of an NGDS acquisition strategy. Respondents are encouraged to clearly specify which system or subsystem component(s) will be addressed in their submissions and whether these functional components are integrated into one platform or are modular. Companies are encouraged to provide a brief description of on-going commercialization and developmental efforts for the proposed system or components which will be matured over the next 2-4 years. Also, the Government is interested in the companys strategic partnerships or cooperative research and developmental areas that the candidate technology may leverage in the development process. Companies interested and qualified in meeting these requirements can forward the information requested herein to NGDSRFI@amedd.army.mil for receipt not later than 4:00 p.m. Eastern Standard Time, 22 November 2010. Hard copy responses will also be accepted for receipt not later than 4:00 p.m. Eastern Standard Time, 22 November 2010, mailed to CBMS/BSV, Cynthia Gnam, ATTN: MELODY SMITH, 64 Thomas Johnson Drive, Frederick, MD 21702. In order to ensure your response is received and considered, DO NOT SEND INFORMATION OR QUESTIONS TO ANY OTHER ADDRESSES. Eligibility in participating in a future solicitation related to NGDS-Increment 1 does NOT depend upon a response to this notice. All information received in response to this RFI that is marked company proprietary will be handled accordingly. If proprietary information is submitted, it must clearly be marked proprietary on every sheet containing such information, and the proprietary information must be segregated to the maximum extent practicable from other portions of the response (e.g., use an attachment or exhibit). Information provided in response to this RFI will not be returned. 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. Any questions regarding this Notice should be submitted ONLY to NGDSRFI@amedd.army.mil. This announcement and any additional information, when published, may also be found on the Joint Program Executive Office for Chemical and Biological Defense (JPEO CBD) website at: http://www.jpeocbd.osd.mil/packs/Default.aspx?pg=321.
- Web Link
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- Record
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