SOURCES SOUGHT
66 -- JOINT PROJECT MANAGEMENT MEDICAL COUNTERMEASURE SYSTEMS (JPM-MCS) - REQUEST FOR INFORMATION (RFI) - Identification of Diagnostic Devices for Biological, Chemical, Toxin, and Nuclear Threats
- Notice Date
- 3/24/2015
- Notice Type
- Sources Sought
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- ACC-APG - 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-15-S-0006
- Response Due
- 4/8/2015
- Archive Date
- 5/23/2015
- Point of Contact
- Jennifer, 301-619-8401
- E-Mail Address
-
ACC-APG - Natick (SPS)
(jennifer.s.bassett.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- SYNOPSIS: The purpose of this Request For Information (RFI) is to conduct Market Research for the advanced development, procurement, fielding, and sustainment of medical treatment, prophylactic, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) warfare agents. Respondents are invited to provide materials related to their capabilities to fulfill ALL or ANY of the requirements listed below. Respondents should provide whether their level of interest and current capability is to fulfill the entire scope of the effort, or a limited aspect of the effort, such as teaming as a subcontractor with another firm. If candidates are interested in teaming with other sources, please include in your response authorization to release your company's name, area of interest, and POC information to be made available on a public website. All proprietary information should be identified as Company Proprietary. Do not use Government Security classification markings. This is a Request for Information (RFI) for planning purposes only, as defined in FAR 15.201(e). This is not a solicitation or request for competitive proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. The Government will not reimburse respondents for preparation of the response. BACKGROUND: The Joint Project Management Office Medical Countermeasure Systems (JPM-MCS), under the Joint Program Executive Office for Chemical and Biological Defense (JPEO-CBD), is the DOD organization responsible for the advanced development, procurement, fielding, and sustainment of medical treatment, prophylactic, and diagnostic capabilities against chemical, biological, radiological, and nuclear (CBRN) warfare agents. Information gathered in response to this RFI will be used to support the Joint Product Director for Diagnostics (JPdM Dx) in strategic planning for development of the Next Generation Diagnostics System Increment 2 (NGDS Inc 2) acquisition strategy. Specifically, information gathered will be reviewed as part of a market survey in support of the NGDS Inc 2 Request For Proposals (RFP) expected to be released by late summer/early Fall 2015. OBJECTIVES: JPM-MCS is interested in collecting information from companies who are currently in the U.S. domestic healthcare market or are considering a future entry into the market for FDA-cleared diagnostics for human diseases caused by exposure to biological, chemical, toxin, and radiological threat agents. JPM-MCS is interested in collecting information about diagnostics systems that are complementary to, and to be used in conjunction with, the NGDS Inc 1 sample-to-answer molecular (PCR) diagnostic platform (Biofire FilmArray) used in forward-deployed clinical laboratories (i.e. combat support hospitals and ships). The NGDS Inc 2 program is seeking information on affinity-based diagnostics systems or other alternatives to PCR-based diagnostics systems. A biomarker-based diagnostics approach is desirable where direct antigen detection is not feasible due to low concentrations of circulating threat agents in relevant clinical samples such as whole blood or sputum. The NGDS Inc 2 program is interested in assay designs focusing on detection of host-response biomarkers, including serological assays, as indication of CBRN exposure. However, novel application of PCR-based technologies for CBRN diagnostics will be considered if not redundant to the NGDS Inc 1 system. Patients may be tested pre-symptomatically or within 12 to 120 hours of exhibiting symptoms, depending on the location of the clinic/laboratory. CBRN threats that are of specific interest to the NGDS Inc 2 program include: * Intracellular bacterial pathogens: Brucella spp., Rickettsia spp., Coxiella burnetii * Burkholderia spp. * Biological toxins: Botulinum toxin, Ricin, staphylococcal enterotoxin B (SEB) * Viruses: Alphavirus spp. * Chemical Warfare agents: Nerve agents, blood agents, choking agents * Radiological exposures Applications for these technologies and systems include: * Use at small clinical laboratories providing centralized support to fixed site and mobile hospitals less than 200 beds * Point of Care diagnostics in a CLIA-waived setting * HIPAA-Compliant communications and data processing tools supporting remote data analysis/interpretation of point of care sample analyses (if applicable) * Non-invasive or very low invasive population screening tools to identify people who may benefit from follow-on diagnostic testing Desired characteristics, as applicable to threat agent and/or application [T] Threshold, [O] Objective * Detection of disease specific host biomarkers (describe the technical maturity and regulatory framework for associated biomarkers) * Detection of agent specific proteins and biomolecules * Supportive of syndrome based diagnostics with endemic diseases with the same patient inclusion criteria, if applicable [O] * Sensitivity relevant to the disease state/application * Highly specific Portable, total system weight (0.5 lbs. [O], 15 lbs. [T]) * Existing or emerging FDA regulatory framework to support development and 510k clearance/ PMA approval * FDA cleared for in-vitro diagnostics [O] or sufficiently mature to begin U.S. FDA Clinical Trials no later than January 2017 [T]Safe for use with BSL 4 agents (low risk of aerosolizing sample materials) [T] * Single Sample Time to Result (5 minutes [O], 30 minutes [T]). If greater than 30 minutes, please explain why this is the state of the art for the threat/application * Complexity (CLIA-waived [O], Moderate [T]), if highly complex please explain why this is the state of the art for the threat/application * Single use consumable or reusable, adaptable instrument/assay based system * Open Architecture (supporting 3rd party assay design and development, non-proprietary file formats) [O] * Electronically enabled for data archiving and communications (or explain how the data may be captured permanently) SUBMISSION INSTRUCTIONS: All written responses must be received within Fifteen (15) Calendar Days of issuance of this RFI. Submissions should: (1) Use Microsoft Word or Adobe Portable Document Format (PDF); (2) Be sent to the POCs identified below (email is preferred); (3) Be complete, sufficiently detailed, and organized in a manner that tracks to the information requested in this RFI; (4) Include a single company point of contact with name, title, address, telephone numbers, and e-mail address (es); and (5) Not exceed 15 single-sided pages in total (not including cover page and cover letter). Other media types (i.e., CD, printed technical information) that meet the submission criteria above will be accepted. Material that is advertisement only in nature is not desired. Please address responses to this notice to: Contracting Officer, Ms. Jessica Ely: Jessica.l.ely.civ@mail.mil Contract Specialist, Jennifer Bassett: jennifer.s.bassett.civ@mail.mil Please designate a company point of contact (telephone, address, and email). All questions regarding this RFI must be in writing or emailed. No telephone inquiries will be accepted. The North American Industry Classification System (NAICS) Code for this notice is 334516 quote mark Analytical Laboratory Instrument Manufacturing, quote mark with a size standard of 500 employees. Responders must identify their company's business size (based on the NAICS size standard), business status (i.e. small business, disadvantaged, HUBzone, woman owned, service disabled veteran owned). Please ensure that your registration in the System for Award Management (SAM) is up to date prior to submission of your response. Further information and registration information may be found at the following website: https://www.sam.gov/portal/public/SAM/
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/notices/b272d80fa85f835e319bc9ec2b2370ad)
- Place of Performance
- Address: ACC-APG - 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
- SN03677667-W 20150326/150324235450-b272d80fa85f835e319bc9ec2b2370ad (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |