SOURCES SOUGHT
66 -- Next Generation Diagnostics System (NGDS) Request for Information (RFI)
- Notice Date
- 10/27/2011
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- ACC-APG SCRT - Natick (SPS), ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street, Natick, MA 01760-5011
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-12-R-NGDS
- Response Due
- 11/18/2011
- Archive Date
- 1/17/2012
- Point of Contact
- John Conlin, 508-233-6164
- E-Mail Address
-
ACC-APG SCRT - Natick (SPS)
(john.conlin3@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Next Generation Diagnostics System (NGDS) Request for Information (RFI) October 27, 2011 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 Request for Information (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 acquisition program is intended to provide FDA-cleared diagnostic capabilities for Chemical, Biological, Radiological, and Nuclear (CBRN) threats and emerging threats of operational concern. The anticipated acquisition strategy for NGDS is to develop, test and field an initial U.S. Food and Drug Administration (FDA)-cleared CBRN diagnostic capability and add additional FDA-cleared assays over a 4-year period. The NGDS program is also interested in enabling technologies to enhance the patient screening and collection and transport of clinical samples for diagnostic analysis. A broad range of potential materiel solutions may be applicable to NGDS Increment 1: -Diagnostic molecular detection platforms and assays -Diagnostic immunoassay detection platforms and assays -Assays for pathogens, toxins and/or biomarkers of chemical, biological or radiological exposure -Automated sample preparation - integrated or modular -Clinical sample collection, preservation, packaging and transport kits -Analytical support equipment (perishable consumable storage/preservation, sample tracking, work flow aids, contamination control, waste disposal) Desired Capability: Respondents are requested to describe their diagnostic system with respect to the following desired capabilities. -Rapid identification of multiple pathogens, toxins or host response biomarkers in a broad range clinical sample matrices (blood, sputum, stool, urine) ---Technical approach used for sample preparation and analysis ---List of existing 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 [18 C-28 C for >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 [<< 2 weeks for laboratory technician skill level] -Communication via Ethernet / USB 2.0 [Net Ready] -Power usage and compatibility -Total footprint (ft2), cube (ft3) and weight in operational configuration and shipping configuration, including support equipment (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 [<84 lbs. in accordance with Mil-Std-1472F] -Physical shock, vibration and weather resistance in transit/shipping configuration -Need for secondary containment for sample processing - i.e. glove box / hood Additionally, respondents are requested to address the following in their response: -Availability of hardware, software and assays for delivery by May 2012 to support a planned capabilities demonstration/testing FDA clearance, pending 510k, or EMEA/CE Mark for diagnostic systems and assays -CLIA Complexity categorization (i.e. CLIA-waived, moderately complex, highly complex) -Confirmation that any electrical hardware is either UL or ENEC listed -Diagnostic systems and consumables 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 -Any previous or existing contracts with DoD or other US Government agencies awarded for diagnostic systems or CBRN assays -Company's ability to rapidly develop and conduct FDA clinical trials for multiple assays for platform simultaneously (up to 6) -Company's ability to support multiple Government research and assay development efforts through the provision of research use only assays or the establishment of a partnership with Government developers. -Company's surge capacity to produce DoD-unique assays, once developed -Volume unit cost for system and assays -Open architecture software / file formats readable without proprietary software -Compatibility with electronic patient records / HIPAA compliance -Current commercial applications of system -Intellectual property position, licenses and Government Use Rights -Plans to ensure stability of manufacturing and supply through the year 2024 -Available warranty and service agreements -Small Business status for North American Industry Classification System code 334516 - Analytical Laboratory Instrument Manufacturing, which has a size standard of 500 employees. -Company's compliance with generally accepted accounting practices or DCAA approved accounting practices. 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 systems will be operated in permissive, improved locations with line power, lighting and a stable fixed, mobile, or fly-away laboratory workspace -NGDS Increment 1 systems will be adapted for use in shipboard environments Acquisition scenarios: -Standalone automated sample preparation system to decrease operator time, logistic footprint and per sample cost -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 of Information: Information gathered in response to this RFI will be used to support the development of an NGDS acquisition and contracting strategy. Respondents should specifically identify which system, subsystems, or component(s) in this RFI submission 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 company's strategic partnerships or cooperative research and developmental areas that the candidate technology may leverage in the development process. Respondents shall provide the company POC, address, email, phone, and facsimile information. This notice is being released by the U.S. Army Contracting Command-Aberdeen Proving Ground, Attn: John Conlin (John.Conlin3@us.army.mil), Contract Specialist, Natick Contracting Division, 100 Medway Road, Milford, MA 01757. Request responses to this RFI to the Contract Specialist stated below by 1600 hours EST, November 18, 2011. Written responses to this RFI notice must be forwarded to Mr. John Conlin via e-mail and/or hardcopy to the above mentioned mailing addresses. The Government makes no future guarantees of a Request for Proposal (RFP) release on a NGDS program. This RFI is issued solely for information and planning purposes and does not constitute a solicitation or issuance thereof. All information received in response to this RFI that is marked company proprietary will be handled accordingly. Responses 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.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/f38bf9574037414873f853e691c4c321)
- Place of Performance
- Address: ACC-APG SCRT - Natick (SPS) ATTN: AMSRD-ACC-N, Natick Contracting Division (R and BaseOPS), Building 1, Kansas Street Natick MA
- Zip Code: 01760-5011
- Zip Code: 01760-5011
- Record
- SN02613913-W 20111029/111027234304-f38bf9574037414873f853e691c4c321 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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