Lab Testing

AGNOSTIC DIAGNOSTICS

A next-generation sequencing-based diagnostic test to identify any and every pathogen for pandemic preparedness

OVERVIEW

During a disease outbreak, an agnostic diagnostic (a diagnostic that can detect any pathogen) would be a powerful tool to aid the public health response from day one. Next-generation sequencing (NGS) technologies can identify any pathogen present in a sample — including emerging pathogens. DRIVe is supporting innovation in metagenomic NGS technologies to bring this much-needed capability closer to commercialization as an agnostic diagnostic for future pandemic preparation.

APPROACH

DRIVe started with an agnostic metagenomic NGS (mNGS)-based diagnostic covering all known and unknown respiratory RNA viruses. Presently, our focus is on technological advancements to facilitate agnostic mNGS-based diagnostics for viral pathogens in clinical laboratories and point-of-care settings. Our pursuit of innovation includes:

  • Pioneering novel, accurate, and portable  sequencing hardware
  • Enhancing speed, efficiency, and integration of  sample preparation methods
  • Promoting user-friendly, automated, and platform-agnostic  bioinformatics approaches

Program Goals

Program Goals
Clinically Relevant Assay

Develop a sample-to-answer system that runs in under 24 hours

Program Goals
Multi-platform Technologies

Create assays compatible with both short and long-read sequencers

Program Goals
Commercial Success and Market Adoption

Develop strategies to facilitate commercialization and gain acceptance in clinical laboratory settings

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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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Paused

1/15/24

Amendment

#020

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Reopened AOI

2/12/24

Amendment

#023

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Extended
Closing Date

5/1/24

Amendment

#028

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New Amendement

9/24/24

Amendment

#30

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Funding
closes

9/30/24

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...

TPP Banner
BARDA’s Metagenomic NGS-Based Agnostic Diagnostic TPP

TPPs define the ideal attributes of products of interest to BARDA and show the ultimate goals of the proposed development effort such as disease indication, patient population, delivery mode ...

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Collaborating to identify challenges and solutions for NGS-based agnostic diagnostic technologies

Next generation sequencing (NGS) has the potential to change the paradigm of traditional diagnostics

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Validation of the VirCapSeq-VERT system for differential diagnosis, detection, and surveillance of viral infections​

There is a need in clinical microbiology and public health for assays that enable sensitive and rapid detection of infectious agents...

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Agnostic Diagnostics program is open until September 30, 2024