Responses Due By

2022-05-16 23:59:59 US/Eastern Time

Work With Us - Commercial Companies - Submit Solution

EXHALE - Exhaled Breath Diagnostics

Project Description

Modern warfighters routinely operate in remote and austere environments where access to diagnostic testing or medical personnel is limited. In these environments, the risk of contracting an infectious disease is often high, and sudden illness can lead to mission failure. Existing mobile diagnostic testing equipment is often too large, too invasive, too slow, or too complex to be deployed in a complex operational environment. 


The Department of Defense (DoD) seeks submissions for a hand-held device capable of non-invasively detecting pre-symptomatic early infection of a human subject through an analysis of volatile organic components (VOC) and/or exhaled aerosols present in the subject’s exhaled breath. We envision that the device will allow on‐demand detection of an infected subject upon actively exhaling onto/into a sensor. Submissions should describe the development of a prototype that will be ready for independent testing with human subjects within 12 months of award. 


Specific capabilities of interest include:


  • Ability to detect infection 24-72 hours prior to symptom onset or in individuals without symptoms or with limited symptoms.
  • Ability to distinguish between healthy and infected humans with any of the following, including, but not limited to: two (2) respiratory diseases of viral origin (for example SARS‐CoV‐2, Influenza, or adenovirus) and two (2) bacterial etiologies (for example, Streptococcus pneumonia, Yersinia pestis, or Acinetobacter baumannii).
  • Explain how sensitive personal information will be encrypted and/or protected on the device and through data transmission.
  • Explain how the device can meet MIL-STD-810H.
  • Explain environmental impact for disposable components.
  • Ability to connect to compact and ubiquitous platforms such as cell phones, radios, or Android Team Awareness Kit (ATAK) devices. This device should support analytical software with:
    • AES-256 Encryption;
    • Capability to receive analytical upgrades (such as algorithms);
    • Standard charging connections (i.e. USB family, inductive); and
    • Connectivity via Bluetooth, Near-frequency Magnetic Induction (NFMI).
  • Specifications of this solution include:
    • Disposable mouthpiece for collection/detection of VOCs
    • Size Weight and Power (SWaP)
      • Breath sensor plus readout (unit) - portable size (e.g. <20 cm x 15 cm x 10 cm)
      • W: <1kg
      • P: Self‐contained (e.g., AA batteries)
    • Sensor module
    • Aim to achieve <$2,000 (hardware) and price per test < $5


Alternative (non-exhaled breath or exhaled aerosols) solutions may be considered. However, all solutions will be held to a similar standard with respect to ease of sampling. 


Submissions must include a description of a clinical study plan to identify breath signatures in human populations and to independently evaluate prototypes in human populations. The study plan descriptions must include the names and institutional affiliations of clinical investigators that will lead the studies. Study plans may be Food and Drug Administration (FDA) regulated or non-FDA regulated with local Institutional Review Board (IRB) oversight.


Companies will be expected to draft regulatory plans describing how the performer will complete all FDA submission requirements for a full submission. Initial conversations with the FDA for approval steps should be complete by the end of the award.


Companies must indicate in their written proposal the maturity of their technology and identify any commercial or other security applications that are using their solution. 


The government may recommend teaming arrangements among submissions offering complimentary capabilities to achieve desired effect. Companies are also welcome to present their own teaming arrangements in their solution briefs. However, if a component of a solution brief is compelling, the government may recommend that the provider of that component team with another solution provider. 


Companies without a Commercial and Government Entity (CAGE) code will be required to register in System for Award Management (SAM) if selected. The government recommends that prospective companies begin this process as early as possible. 


Companies must also provide a good faith representation of ownership or appropriate licensing/data rights to the solutions being presented or who or how the company intends to fulfill the needs.


Solicitation Phases:


Phase I: Solution Brief Evaluation - This phase will be executed in accordance with the DIU Commercial Solutions Opening (CSO) process. All solution briefs correctly submitted in response to an AOI will be evaluated against the stated criteria below.


  1. Relevance of the Solution Brief in addressing the AOI;
  2. Company’s approach and/or underlying technology is unique, underutilized and/or innovative to government application. In addition, the government finds this approach and/or underlying technology to be a compelling solution to the AOI problem statement.
  3. Technical merit and feasibility of the solution to address the government’s AOI problem statement.


Phase II: Demonstration/Pitch - This phase will be executed in accordance with the DIU CSO process with the following modifications. The pitch phase may be held in person. The Pitch Phase will require a recorded video demonstration of the baseline technology to be used to develop the proposed solution. The intent is to provide the evaluation team with an understanding of the current maturity of the proposed solution. The government will not provide funding for company participation in Phase II. Specific details will be provided if your company is invited to the Phase II Pitch.


Phase III: Proposal - This phase will be executed in accordance with the DIU CSO process and will consist of a collaboratively developed performance work statement (PWS), technical proposal, cost proposal, and the OTA terms and conditions.


Submission Requirements

Submissions should include an overview and technical details of the proposed solution. Inclusion of examples of the successful deployment of similar solutions in the commercial or public sectors is highly encouraged. 


Preference will be given to submissions that present a comprehensive and compelling solution to the problem statement and product requirements. Proposals should identify whether the submitter will employ subcontractors and, if so, which companies would deliver which capabilities. 


Any resulting agreement from this AOI will include language requiring your company to confirm compliance with Section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232). If you are unable to confirm compliance with the referenced law, the government will not be able to enter into an agreement with your company


Awarding Instrument:


This Area of Interest solicitation will be awarded in accordance with the Commercial Solutions Opening (CSO) process detailed within HQ0034-20-09-DIU posted to www.sam.gov in March 2020. Additionally this document can be found within the DIU Library at www.diu.mil/library.


References:


1. Amundson DE, Weiss PJ. 1994. Pneumonia in military recruits. Mil Med 159:629–631.

2. Sanchez JL et al., Respiratory Infections in the U.S. Military: Recent Experience and Control, ClinMicrobiol Rev. 2015, 28(3): 743‐800; https://www.ncbi.nlm.nih.gov/pmc

Before You Submit

Companies are advised that any Prototype Other Transaction (OT) agreement awarded in response to this solicitation may result in the direct award of a follow-on production contract or agreement without the use of further competitive procedures. Follow-on production activities will result from successful prototype completion.

The follow-on production contract or agreement will be available for use by one or more organizations within the Department of Defense. As a result, the magnitude of the follow-on production contract or agreement could be significantly larger than that of the Prototype OT agreement. All Prototype OT agreements will include the following statement relative to the potential for follow-on production: “In accordance with 10 U.S.C. § 4022(f), and upon a determination that the prototype project for this transaction has successfully been completed, this competitively awarded Prototype OT agreement may result in the award of a follow-on production contract or transaction without the use of competitive procedures.”

2018 Other Transaction Guide

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Solution Brief

Solution briefs must be saved as a PDF that is 10MB or smaller. Papers should be approximately 5 or fewer pages and slide decks should be approximately 15 or fewer slides.

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Any agreement awarded off of this solicitation will include language requiring your company to confirm compliance with Section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232). If you are not able to comply with the law, the Government may not be able to award the agreement.

We Work With You

If we think there’s a good match between your solution and our DoD partners, we’ll invite you to provide us with a full proposal — this is the beginning of negotiating all the terms and conditions of a proposed prototype contract.

After a successful prototype, the relationship can continue and even grow, as your company and any interested DoD entity can easily enter into follow-on contracts.

Our Process

  1. We solicit commercial solutions that address current needs of our DoD partners.

  2. You send us a short brief about your solution.

  3. We’ll get back to you within 30 days if we’re interested in learning more through a pitch. If we're not interested, we'll strive to let you know ASAP.