Lab Testing

AGNOSTIC DIAGNOSTICS

A next-generation sequencing-based diagnostic test to identify any and every pathogen from a single sample

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OVERVIEW

During a disease outbreak, an agnostic diagnostic (one that detects any pathogen) would be a powerful tool to help the public health response from day one. Next-generation sequencing (NGS) technologies can identify any pathogen present in a sample — including new pathogens. DRIVe is supporting the analytical and clinical validation of NGS-based agnostic diagnostic assays to bring this much-needed capability closer to commercialization for future pandemic preparation.

PARTNERS

Companies we have partnered with on this program to date


APPROACH

DRIVe is starting with an NGS-based diagnostic that will cover all known and unknown respiratory RNA viruses. Partners will optimize their in-house NGS capabilities for commercial clinical use by:

  • Lowering the sample-to-result time to under 24 hours
  • Reducing interference from host RNA
  • Performing analytical and clinical validation of their platform using both contrived and clinical respiratory samples.

Program Goals

Program Goals
Clinically Relevant Assay

A test that gives results within 24 hrs with sensitivity similar to molecular diagnostic assays

Program Goals
Multi-platform Technologies

Assays designed for short and long-read sequencers

Program Goals
Pathways to Market

Clear regulatory strategies toward commercialization

Lab Testing

Agnostic Diagnostics

Funding
Opened

8/25/21

Amendment

#14

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New AOI
Opened

9/13/23

Amendment

#012

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Funding
Closes

1/15/24

Related Publications

Program Goals
BARDA announces new partnerships to develop nextgen diagnostics for any respiratory RNA virus

BARDA's Division of Research, Innovation, and Ventures (DRIVe) is collaborating with multiple industry and academic partners to advance the ability to quickly respond to public health emergencies with a new...

Looking for General FAQ?

Agnostic Diagnostics program is open until January 15, 2024