SOURCES SOUGHT
A -- In Vitro Affinity-based Diagnostic System for Diseases Resulting from Chemical, Biological, and Radiological Exposure
- Notice Date
- 5/11/2018
- Notice Type
- Sources Sought
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- Department of the Army, Army Contracting Command, ACC - APG (W911QY) Natick (SPS), 10 General Green Avenue, Building 1, Natick, Massachusetts, 01760-5011, United States
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY18S0007
- Archive Date
- 7/7/2018
- Point of Contact
- Richard Totten, Phone: 3016192446
- E-Mail Address
-
richard.w.totten2.civ@mail.mil
(richard.w.totten2.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- REQUEST FOR INFORMATION In Vitro Affinity-based Diagnostic System for Diseases Resulting from Chemical, Biological, and Radiological Exposure Objective: This is a Second Request for Information (RFI) for planning purposes only. 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. The Joint Program Executive Office for Chemical and Biological Defense (Medical Countermeasures Systems) is seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) in the areas listed below. Briefly, the Medical Countermeasure Systems - Joint Product Lead for Diagnostics (MCS-DX) seeks responses that will inform future investments in diagnostics to complement current and planned polymerase chain reaction (PCR)-based capabilities. Technologies should enable clinically-relevant diagnosis of chemical, biological, or radiological (CBR) warfare agent intoxication or infection at early points in disease progression. Of additional interest are systems that leverage or integrate with routine, non-CBR, healthcare capabilities to favor broader adoption across the services and enhance force readiness. Background: MCS-DX is responsible for the development, acquisition, and sustainment of FDA-cleared diagnostic devices intended for use by Service Members in the diagnosis, prevention, and treatment of exposure to CBR agents. Currently, MCS-DX is fielding a molecular assay (PCR) system for diagnosis of infection with a limited set of biological threats. However, there are instances where the molecular pathology of disease suggests PCR is not an effective methodology. Such a situation may arise with biological threats early in infection or with organisms that become compartmentalized and sequestered (e.g. in abscesses of internal organs) from easily accessible sample types. MCS-DX desires information regarding systems, and their components, that may address those instances. Traditional and non-traditional defense contractors, including companies new to working with the DoD, are encouraged to respond. Companies currently in the U.S. domestic healthcare market, or considering entry into the FDA-cleared diagnostics market, are especially encouraged to respond. Respondents are invited to provide information related to their capabilities to fulfill any portion of the requirements listed below. Companies with an enabling technology that may serve as a component within a diagnostic system (e.g. clinical sample collection and preservation, sample preparation, assay designs, etc.) are encouraged to respond. All proprietary information should be identified as Company Proprietary. Do not use Government Security Classification markings. Concept of Employment and Operational Environment Capabilities developed and fielded by MCS-DX are intended for use by a variety of U.S. personnel in a range of deployed locations. A combat medic or physician assistant on the frontline may need to perform diagnostics in a fairly uncontrolled environment, such as a Battalion Aid Station tent. Further from the frontline, yet still "in theatre", a dedicated laboratory technician of a 50-bed combat support hospital may need to perform diagnostics of all levels of complexity in a controlled operational environment, not unlike many Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories. Service Members are evacuated through this combat health support system depending on severity of illness and assessed ability to return to duty. As such, clinical sampling and field diagnostic testing is likely to occur between 0 and 168 hours after acute symptom onset. Additionally, CBR diagnostics are used in parallel with, and are subservient to, routine combat casualty care (i.e., trauma and endemic disease medical countermeasures). Thus, it is highly desired for CBR diagnostic capabilities to leverage routine, non-CBR health care capabilities such as clinical chemistry tests, endemic infectious disease tests, traumatic brain injury screening, and specific or non-specific insult/injury host-response. The Department of Defense (DoD) currently operates multiplex-PCR diagnostics in the controlled laboratory environment mentioned above and expects to deploy additional PCR-based, CBR diagnostic capabilities closer to the combat frontline by 2022. Any new capabilities must complement the existing diagnostics family of systems to improve patient health outcomes and force health decisions. Requirements: The purpose of this RFI is to solicit information on the availability or developmental status of affinity-based systems, or other alternatives to polymerase chain reaction (PCR)-based systems, for diagnosis of intoxication or infection with CBR warfare agents. Responses will inform market research for the advanced development, procurement, fielding, and sustainment of a reusable, lightweight, low-complexity, in vitro diagnostic (IVD) capability. 1. MCS-DX is interested in a reusable, multiplex diagnostic platform with application to CBR threats including, but not limited to, the following: a. Intracellular bacterial pathogen infection: Brucellosis (Brucella spp.), epidemic typhus (Rickettsia prowazekii), Q Fever (Coxiella burnetii), Melioidosis (Burkholderia spp.), and syndromic near-neighbors for which a differential diagnostic impacts clinical treatment course b. Viruses: Encephalitic alphaviruses (Eastern, Western, Venezuelan Equine Encephalitis virus) c. Biological toxins: botulism (botulinum toxin), ricin, food poisoning (staphylococcal enterotoxin B; SEB), Anthrax (Bacillus anthracis) d. Non-specific viral vs. bacterial screening e. External gamma radiation exposure testing (>6 Gy) and triage screening (>2 Gy) 2. Diagnostic Targets: Agent-derived or host-response biomarkers are acceptable for each disease. 3. Clinical Sample Types: Non-invasive or minimally invasive sample types consistent with collection and analyses in austere environments (e.g., capillary whole blood, venous whole blood, saliva, urine, sputum, stool, exudates, etc.). 4. Data and Communications: HIPAA-compliant communications and data processing tools supporting remote data analysis/interpretation of point-of-care sample analyses, if applicable, should be described. 5. Time to Result: Rapid sample-to-answer protocol is highly desired - if greater than 120 minutes, please explain why this is the state of the art for the threat/application. Rapid protocols support administration of appropriate clinical treatment at earlier points in disease progression. 6. Ease-of-Use: Moderate complexity to CLIA-waived - if highly complex please explain why this is the state of the art for the threat/application. 7. Product Maturity: FDA-cleared IVD or sufficiently mature to begin clinical trials no later than 2023. 8. Other Considerations: Safety features for use with BSL 4 agents, including limited user exposure to contaminated sample and minimized risk of aerosolizing sample materials, are desirable. Additionally, support of 3rd-party components through open architecture assay or device design, as well as non-proprietary file formats, is advantageous for integration across Services and should be described. Performance Objectives: In fewer than 10 pages (single-sided; not including cover page and cover letter), respondents are encouraged to address the above desired characteristics and the below informative details: • Total system weight and dimensions - inclusive of instrumentation and consumables • Ability to process multiple clinical sample matrices relevant to disease status • Assay methodology (e.g. sample preparation, performance steps, detection and analysis methods) • Applicability of system to other morbidities of military relevance (e.g. traumatic brain injury, infectious disease, or cardiac care) • Other commercial assays (in development or currently available), on the described system, that address a DoD routine healthcare capability • Relevant efforts in the discovery pipeline (e.g. antibody, antigen, or biomarker identification efforts) • Synopsis of any relevant experience with the regulatory approval process, including providing capabilities under Emergency Use Authorization • Description of IVD applications under development with the proposed system • Existing or emerging FDA regulatory framework to support development and 510(k) clearance/PMA approval • Assay storage requirements - study-demonstrated (e.g. room temperature, refrigerated, frozen) • Shelf-life extent - supported by current Good Manufacturing Practices stability studies. • Manufacturing capabilities - system or kit production rates; COTS or outsourced component availability • Estimated cost per test - clearly explain plexity (per sample, per target, per run, etc.) • Alignment with planned technology transitions between academia, industry, government • Associated intellectual property rights or patent coverage • Willingness to enter into agreements with the DoD utilizing the medical countermeasures Other Transaction Authority (OTA) via membership in the MCDC (www.medcbrn.org) Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary. Do not use Government security classification markings. All written responses must be received by 4:00 pm on 22 June 2018. Responses should be sent by e-mail to: usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil with Subject line of Responding Organization Name and RFI Title. Please direct any questions to the same address. The Point of contact for this RFI is Mr. Barry Sayer, (301)619-2709. Material that is advertisement only in nature is not desired. If a solicitation is subsequently released based on the responses to this RFI the first choice for an acquisition vehicle, if appropriate, will be the Medical CBRN Defense Consortium (MCDC) Other Transaction Agreement (OTA). Respondents not already members of the consortium are encouraged to join at www.medcbrn.org. Respondents may also inquire about the MCDC at mcdc@ati.org.
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