Assay Expansion for Chemical Diagnostic System - EverGlade Consulting

Assay Expansion for Chemical Diagnostic System

handheld diagnostic device

The Defense Threat Reduction Agency’s Medical Diagnostics Branch (RD-CBMD) is driving innovation with its 2026 solicitation to expand the ChemDx platform. ChemDx is a handheld diagnostic device for rapid detection of chemical threats, such as nerve agents or certain pesticides, in blood from a finger prick. This effort seeks proposals from organizations interested in broadening the ChemDx system’s diagnostic capabilities to cover a wider range of harmful agents. RD-CBMD is particularly interested in adding assays for detection of opioids, pharmaceutical-based agents (PBAs), vesicants, and other toxic chemicals to the ChemDx platform, transforming ChemDx into an all-encompassing diagnostic tool for warfighters in challenging environments.

Key Proposal Information

Technical approaches that include adaptation of established assays or novel methods are equally welcomed to apply. The test sample must be minimally invasive, such as saliva, sweat, or blood from a finger prick, and proposers must be willing and able to work with the ChemDx manufacturers to integrate additional assays. The solicitation specifies the following key project objectives:

  1. Description of the scientific foundation for the proposed technology, including sensor target, sensor chemistry, sensing method, sample matrices, and potential challenges.
  2. Current Technology Readiness Level (TRL) with capacity to achieve at least TLR 4 by conclusion of the Period of Performance (24 months).
  3. Technical sensor development approach and feasibility to integrate into the ChemDx platform.
  4. Description of sensor characteristics and approach to electrochemical signal, as well as the anticipated test strip format, storage conditions, and diagnostic time.
  5. Ability to multiplex targets on the ChemDx sensor.
  6. Preliminary data and/or published literature supporting the proposed sensor technology.
  7. Any Intellectual Property associated with the proposed assay and platform.
  8. Plan to deliver a functional TRL 4 prototype for analytical testing within 24 months of award and ability to integrate the prototype with the ChemDx system.

In addition, proposers are required to submit a detailed regulatory strategy document including a draft intended use statement, analytical and clinical study plans, specimen requirements, and a target product profile.

Additional Considerations

Proposed devices that are compatible with the ChemDx platform, portable, storable at room temperature, ruggedized, and operable between 4-50oC with a minimally invasive sample are highly desirable. It is anticipated that the effort may extend beyond the 24-month Period of Performance to iteratively develop additional assay targets. This effort is anticipated for award in Q3 of FY2025.

If your company has considered applying for DTRA funding, your federal funding journey starts here.

For additional information about EverGlade Consulting, reach out to: [email protected]

Collaborate With Everglade Consulting

EverGlade Consulting is a national consulting firm connecting public sector needs with private sector solutions. We offer services ranging from Pursuit, Proposal, and Post-Award support to comply with federal regulations at agencies including BARDA, ASPR, NIH, DTRA, JPEO, DOD, DOE, and DARPA.

Leave a Comment

Your email address will not be published. Required fields are marked *

Scroll to Top
Flask with blue light

Webinar: R&D Funding in Life Sciences: What's Ahead in Trump 2.0?

Join us on Jan 15, 2025, at 12:00pm ET for a deep dive into the future of R&D Funding in Life Sciences.