DIU Solicitation: Detecting Indicators of Chemical Exposure (DICE) Response Due: 14 Nov 2019

1.

Detecting Indicators of Chemical Exposure (DICE):

Military service members are deployed to locations where inadvertent and unprotected exposure to toxic environments is possible.  Moreover, the use of toxic chemicals as terror/warfare agents remains a constant concern.  Similar exposure concerns exist for civilian and military first responder communities who may be required to undertake time sensitive tasks in high risk situations where hazardous chemical materials may be present. In these situations, progression of intoxication might go unrecognized until responders are incapacitated (e.g. Tokyo subway).

As the risk of accidental or adversarial exposure grows, it becomes increasingly important to monitor the health and readiness of the individuals in a proactive manner to facilitate effective triage and medical management of exposed individuals. Capabilities that enable a rapid recognition of exposure will facilitate improved short term risk management and reduced chances of long term physiological impact (e.g. cancer).

Biomarkers/signatures to indicate an individual’s exposure to hazardous chemicals range from physiological (e.g. cardiac metrics, pupil response, nerve conduction velocity) to biochemical (e.g. blood lactate, acetylcholinesterase enzyme activity).  Such physiological signatures or molecular markers, may offer a warning of pending degradation to the human before the onset of mission disruptive symptoms. Continuous passive monitoring of these biomarkers could represent a “check engine light” and should provide actionable cues in situations where progression of symptomology is slow, outcomes are particularly dire, and mitigating diagnostic and treatment interventions are available

This solicitation focuses on repurposing (and extending) technologies recently developed for continuous glucose monitoring and/or physiologic monitoring, and utilizing them to monitor markers of military relevance.   The desired platform should be capable of performing at least 72 hours of continuous monitoring without warfighter intervention (e.g. changing test strips)  The product must detect one (or more) of the following at levels below those resulting in overt symptoms:

1. Exposure to organophosphates
2. Exposure to mustard agents
3. Exposure to opioids

* It must also monitor vital signs if that feature is not included in the specific test it is designed to perform.

Ideally, these technologies should impose a low burden on the individual (preferably completely passive and continuous), so critical personnel remain focused on the task without distraction.

The resulting device is not intended as a diagnostic, and will not replace the existing clinical diagnostic practice.  Rather, it is intended as a queue, enabling people to manage risk and/or seek care prior to presentation of overt symptoms.

Devices and systems should ideally have minimal complexity and be shelf-stable.  Bluetooth communication of status/alerts is preferred with common protocols allowing for integration with the warfighter/responder’s existing suite of equipment.  Prototypes will be requested for third party evaluation at a government facility (minimum of 300 wearable devices, plus additional supporting hardware as required for testing) <24 months post award.

Companies are advised that any Prototype Other Transaction Agreement (OTA) awarded in response to this Area of Interest may result in the award of a follow-on production contract or transaction without the use of further competitive procedures.  The follow-on production contract or transaction will be available for use by one or more organizations in the Department of Defense and, as a result, the magnitude of the follow-on production contract or agreement could be significantly larger than that of the Prototype OTA.  As such, any Prototype Other Transaction Agreement will include the following statement relative to the potential for follow-on production: "In accordance with 10 U.S.C. 2371b(f), and upon a determination that the prototype project for this transaction has been successfully completed, this competitively awarded prototype OTA may result in the award of a follow-on production contract or transaction without the use of competitive procedures.”

Submissions accepted from 11/04/2019 13:30 to 11/14/2019 23:59 PT