Fast and Wide Multiplexing Omics Assay Platform to be Eligible for Far Forward Use and to Meet the Criteria to Get Certification of Waiver (COW) Status from Clinical Laboratory Improvement Amendments (CLIA)
ID: DHA242-001Type: BOTH
Overview

Topic

Fast and Wide Multiplexing Omics Assay Platform to be Eligible for Far Forward Use and to Meet the Criteria to Get Certification of Waiver (COW) Status from Clinical Laboratory Improvement Amendments (CLIA)

Agency

Department of DefenseN/A

Program

Type: SBIRPhase: BOTHYear: 2024

Topic Link

https://www.sbir.gov/node/2608933

Additional Information

https://www.defensesbirsttr.mil/SBIR-STTR/Opportunities/
Timeline
  1. 1
    Release Apr 17, 2024 12:00 AM
  2. 2
    Open May 15, 2024 12:00 AM
  3. 3
    Next Submission Due Jun 12, 2024 12:00 AM
  4. 4
    Close Jun 12, 2024 12:00 AM
Description

The Department of Defense (DOD) is seeking proposals for a Fast and Wide Multiplexing Omics Assay Platform that can be used in far forward settings and meet the criteria for a Certification of Waiver (COW) status from the Clinical Laboratory Improvement Amendments (CLIA). The objective is to develop an in vitro diagnostic (IVD) platform with fast and wide multiplexing capability, capable of detecting at least 25 multi-omics targets from a single input of minimally invasive biomatrix. The platform should have a small footprint, an automated hands-free process, and an insignificant risk of an erroneous result. The prototype should eventually meet the criteria for a COW from CLIA. Phase I will focus on demonstrating the feasibility of the platform, while Phase II will involve transforming the proof-of-concept into a working prototype. Phase III aims to secure FDA approval for the product, with potential applications in both military and civilian settings. Funding could be solicited from CDMRP and BARDA, and partnerships with IVD marker leaders may be pursued. The project duration is not specified, and funding specifics are not provided. The solicitation is currently open, with a closing date of June 12, 2024. For more information, visit the DOD SBIR 24.2 Annual solicitation on grants.gov or the DOD SBIR/STTR Opportunities page on the Defense SBIR/STTR website.

Files
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