The Biomedical Advanced Research and Development Authority (BARDA) Easy Broad Agency Announcement (EZ-BAA) aims to accelerate innovation and improve the availability of transformative tools, products, and technologies to protect from natural and intentional
health security threats.
To streamline the EZ-BAA, Areas of Interests open for a few months at a time following a staggered approach. This approach aims to encourage high-quality submissions earlier in the fiscal year allowing adequate review time. Depending on programmatic need and funding availability, Areas of Interest (AOIs) may be reopened for another period of time.
On 12 Feb 2024, BARDA reopened an AOI under the EZ-BAA for proposals to advance agnostic metagenomic next-generation sequencing (mNGS) diagnostics for viral infection in routine clinical labs and point-of-care settings.
In “Advancing Metagenomic Next-Generation Sequencing-Based Agnostic Diagnostics,” BARDA seeks to address gaps in detecting any pathogen, including novel and emerging, from any human sample type, for any infectious disease condition by requesting abstracts for technologies in one or more of the following areas: sequencing hardware, sample preparation and assay components, and bioinformatics capabilities.
mNGS is a powerful technology that has been well-established in research, surveillance, and biomarker discovery communities. It has the potential to improve diagnostics, especially in cases of unknown or emerging pathogens. An agnostic test based on mNGS that can detect any and every virus, known or unknown, and can be implemented in routine clinical labs and point-of-care settings, could help reshape the public health response to a pandemic. It could also aid in tailoring interventions to improve patient outcomes.
The translation of mNGS as a clinical diagnostic for agnostic detection has not yet occurred due to multiple challenges associated with higher cost, turn-around time, standardization of sample preparation, the complexity of sequencing methods, and bioinformatics analysis.
BARDA is seeking proposals for innovation in one or more of the following areas:
Sequencing Hardware
Novel, accurate, and efficient sequencing technology featuring one or more of the following:
- Reduced size and portability. Platform hardware with a desktop-sized footprint or smaller, that could be moved by a human without assistance with minimal and easy calibration requirements.
- Novel scalable sequencing chemistry and flow cells intended for eventual point-of-care
use in clinical settings.
Sample Preparation, mNGS Assays, and Reagents
Faster, more efficient methods and reagents for sample and library preparation that are automated and portable for clinical use.
- Novel sample preparation methods with fast turnaround time from sample to library
(Less than 3 hours), minimal hands-on time (Less than 45 minutes), and fewer liquid-
handling steps. - Protocols that work for all types of viruses (including both DNA and RNA) and for more
than one sample type (e.g., saliva, NPS, urine, whole blood, serum) with the ability to
adapt to any other pathogen (e.g., bacteria, virus, fungi, or protozoa) are preferred.
Bioinformatics
Software for mNGS data analysis and clinical interpretation.
- Fully automated analysis software with the ability to ingest data from any sequencing
platform for clinical applications using existing/new viral databases. - Novel AI/ML-based algorithms to inform on signal to background and spurious reads,
real-time analysis, clinical interpretation and to predict pathogenicity and/or pandemic
potential of discovered sequences.
Multiple awards are anticipated and are dependent upon the program priorities, scientific/technical merit of abstract submissions, how well the abstract submissions fit within the goals of the AOI, and the availability of funding. The program funding is subject to change based on the Government’s discretion.
Abstracts may be submitted until 15 May 2024. Refer to SAM.gov for the latest information on this funding opportunity. (Amendment 12 and 23).
Sources: BARDA Division of Research, Innovation & Ventures (DRIVe), SAM.gov