SPECIAL NOTICE
A -- Volatile Organic Compound (VoC) based Diagnosis of Infection or Chemical Exposure
- Notice Date
- 10/8/2020 9:51:24 AM
- Notice Type
- Special Notice
- NAICS
- 541715
— Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Contracting Office
- W6QK ACC-APG NATICK NATICK MA 01760-5011 USA
- ZIP Code
- 01760-5011
- Solicitation Number
- W911QY-21-S-0001
- Response Due
- 11/9/2020 9:00:00 AM
- Archive Date
- 11/24/2020
- Description
- REQUEST FOR INFORMATION Volatile Organic Compound (VoC) based Diagnosis of Infection or Chemical Exposure � Objective: This is a 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.� All submitted information will become Government Property and will not be returned.� The Joint Program Executive Office for Chemical and Biological Defense (Medical Countermeasures Systems) and the Joint Science and Technology Office (JSTO) are seeking information on the capabilities and willingness of private entities (academic, non-profit and commercial) in the TWO areas listed below:� Bacterial / Viral Infection AND/OR Chemical Exposure. SECTION I:� A VoC-based Diagnostic Device for Bacterial and Viral Infection � Background:� The detection and identification of infectious agents through non-invasive means is a research area of interest for the Detection and Diagnostics Division (CBA) within the Joint Science and Technology Office (JSTO).� Information regarding possible solutions is sought for the diagnosis of infectious diseases through collection and analysis of an individual�s breath and/or skin emissions. The solution needs to be non-invasive, and collect the required VoC sample relatively quickly and easily at the point-of-care. The VoC biomarkers sampled may include coarse respiratory vapor, droplets with an aerodynamic diameter of >5 �M), and/or fine-particle aerosols with an aerodynamic diameter ? 5 �M.� Possible means of diagnosis shall consider, but are not limited to: Volatile Organic Compounds (VoCs) which may include both host markers or bacterial/viral particles, ultra-sensitive bacterial/viral protein or nucleic acid detection, and any other markers that can be measured with the instrument using non-invasive means (e.g. physiological symptoms).� In addition, any capability to use the system to predict infectious disease onset or severity is of interest. � The diagnostic platform would be a Point-of-Care (PoC)/ Point-of-Need (PON) device.� The device would ideally be amenable to use in austere, low resource settings and support rapid decision-making for warfighter and civilian triage and treatment.� The system needs to be robust enough to be run at a local clinic, primary care physician�s facility, field hospitals including facilities considered to be role 2 or 3 in the Military Health System (e.g. US Army Combat Support Hospitals or Battalion Aid Stations, or their Navy and Air Force equivalents). The device configuration may include a disposable module for the collection/capture of breath components and a reusable rechargeable data analysis/reporting module. The diagnostic system should avoid using a large fixed facility instrument (such as a laboratory based GC or LC MS system that cannot be easily shipped and set up in the envisioned primary care facility). Requirements: The purpose of this RFI is to solicit information on the availability and developmental status of devices used to collect and analyze components directly related to breath for the detection of bacterial/viral infection-related diagnostic markers.� The stretch goal would be a device that would be capable of pre-symptomatic detection of host-based biomarkers indicative of infection. � The ideal device would be simple to use and generalizable to diagnosing acute infections with all medically relevant viruses as well as Gram +/- bacteria. The system will have a low power requirement. The system may be comprised of a disposable collection unit and a reusable analytical unit, incorporate low-cost disposable sample collection, be robust to a temperature range (4�C to +50 �C), low/high humidity, microgravity and not require a cold chain. Performance Objectives:� Beginning TRL = 3-4; Final TRL = 5-6. Duration of patient sampling ? 5 min. Time from Sample Collection to Diagnostic Result not to exceed 30 minutes (threshold) and should ideally be 10-15 minutes (Objective). � The inclusion of clinical data, sensitivity/specificity of detecting a specific infection using the VOC approach, a description of instrument(s) currently in use/testing, relevant databases and the AI/ML configuration. Synopsis of any relevant experience from prior correspondence with the FDA (e.g. past pre-IDE, IDE, 510(K) or 513(K), clinical data) demonstrating a feasible regulatory path forward.� Anticipated shelf life of platform and describe the test conditions for establishing same Describe the size, weight, power requirements and dimensions of footprint. The instrument should be capable of operation using a minimum of either one of two power sources (i.e. 120V, battery, solar). Projected cost per instrument package and projected cost per assay Any associated patent or developmental rights assertions Platform adaptability:� Discuss, if appropriate, whether your system is capable of, or adaptable to performing ambient air sampling for the detection of low concentrations of bacterial cells and viral particles or is restricted to breath, skin emissions as the sample.� SECTION II.� Chemical Exposure VoC-based Diagnostic Requirements: � The purpose of this RFI is to solicit information on the availability and developmental status of devices used to collect and analyze components directly related to breath or epidermal output for the detection of chemical intoxication by organophosphate nerve agents, fentanyls, and cannabinoids.� The device would be capable of detection of pre-symptomatic host-based biomarkers indicative of such intoxication. The ideal device be comprised of a disposable collection unit and a reusable analytical unit.� The complete system would be simple to use, be generalizable to organophospates/fentanyls/cannabinoids as chemical classes, have a low power requirement, be robust to temperatures from 4�C to +50 �C, would withstand conditions of low/high humidity/marine environment (salt water), and would not require a cold chain. Performance Objectives:� a.�������� Beginning TRL = 3-4; Final TRL = 5-6. b.�������� Duration of patient sampling ? 5 min. c.�������� Sample collection�to-answer that meets the Objective/ Threshold times of 1/5 minutes. d.�������� Synopsis of any relevant experience with the FDA including 510(K) and 513(K) submissions.� The inclusion of� clinical data, sensitivity/specificity of detecting a specific infection using the VOC approach, a description of instrument(s) currently in use/testing, relevant databases and the AI/ML configuration. e.�������� Anticipated shelf life of platform and describe the test conditions for establishing f.��������� Size, weight, power requirements and dimensions of footprint g.�������� Projected cost per instrument package and projected cost per assay h.�������� Any associated patent or developmental rights assertions Platform adaptability:� Discuss, if appropriate, whether your system is capable of, or adaptable to performing ambient air sampling for the detection of low concentrations of organophosphate nerve agents, fentanyls, and cannabinoids or is restricted to breath, skin emissions as the sample.� �� ���� RFI Format:� The Respondents shall provide a 6-8 page document addressing the ideal solution for the development of a PoC/PoN breath-based diagnostic platform, performance objectives and the following, in response to this this RFI: 1.�� Company Description Provide a brief company description and history, emphasizing experience developing similar products including other products approved by FDA Discuss any data rights assertions anticipated for the prototypes Do you anticipate any foreign nationals working on the project? � 2.�� System Description A brief description of the key technology(ies) proposed Visual representation of the end state prototype concept A description of current and proposed performance characteristics If available, clinical data demonstrating system performance, sensitivity and specificity with bacteria or viruses from clinical matrices. Proposed size and weight Approximate technology readiness level (TRL) upon prototype delivery � ���� 3. ���Biomarker Database Development (Optional) If a biomarker/chemical reference database is needed to match VOC signatures to facilitate diagnosis, please include the following to describe the approach: Architecture and developmental maturity of the databases Analytical methodology used for sample matching Applicable Artificial Intelligence and Machine Learning approaches The manner in which the device accesses the database Preliminary data supporting the clinical accuracy of the markers in the database ����������������������� 4.�� Cost Provide the Rough Order of Magnitude (ROM) cost estimate of the proposal to develop a prototype for further demonstration, testing, and evaluation. � 5.�� Schedule Proposed timeline/schedule to develop prototype and related technical documentation (technical drawings and build of material) in accordance with the system description. � ���� �6. ��Low-Rate Manufacturing Plan Respondent should discuss options available for low-rate production of two to four prototypes complete with a total of 100 tests each for evaluation by the government by an independent 3rd party of the government�s choosing. � Administration: The Government will retain comments and information received in response to this RFI. Proprietary information should be identified as Company Proprietary and should be kept to a minimum. Do not use Government security classification markings. All written responses must be received by COB on 9 NOV 2020. Responses should be sent by e-mail to: �usarmy.detrick.jpeo-cbd.mbx.mcs-rfi@mail.mil, with Subject Line of Responding Organization and RFI Title. 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. Responders are advised that the U.S. Government will not pay for any information or administrative costs incurred in response to this RFI; all costs associated with responding to this RFI will be solely at the interested party�s expense.� Not responding to this RFI does not preclude participation in any future RFP/RPP, if any is issued. Anticipated contracting action is via CWMD consortium OTA. DTRA is accepting questions regarding this notice but will not be providing responses. The questions will be used to develop more information and receive input from industry regarding this system. The notice is strictly a request for capability packages. If a formal RFP/RPP is issued as result of this notice, Q&A may be allowed at that time.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/e95787f053be43228b9935ce5911f867/view)
- Record
- SN05822692-F 20201010/201008230142 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |