# PANDAA for universal, pan-lineage molecular detection of filoviruses to enable rapid epidemic response.

> **NIH NIH R44** · ALDATU BIOSCIENCES, INC. · 2022 · $964,499

## Abstract

Ebolavirus [EBOV] and Marburgvirus [MARV] are filoviruses that cause severe hemorrhagic fevers in humans and
primates and are listed among the urgently concerning pathogens prioritized in the WHO R&D Blueprint. Genomic
sequences of the EBOV and MARV genera differ by >55%, and within each genera the species sequence diversity
threshold is >23% thus detection by gold standard qPCR-based methods has been encumbered by significant
genetic variability between filoviruses. Clinical diagnosis of EBOV and MARV is difficult as the early stages (i.e., pre-
hemorrhagic) present with non-specific symptoms associated with a range of febrile illnesses that are displayed by
other infectious agents endemic to affected areas e.g., malaria, yellow fever, dengue fever, Crimean-Congo
hemorrhagic (CCHFV) or Lassa fevers. In order to isolate infected individuals, effective control during an EBOV or
MARV outbreak can only be achieved by implementing rapid and accurate diagnostics with consistently reliable
performance. Aldatu has pioneered the use of PANDAA technology, which enables probe-based qPCR for target
detection in highly variable genomic regions by simultaneously adapting and amplifying diverse templates. PANDAA
uniquely mitigates the presence of genetic polymorphisms to allow otherwise divergent templates to be detected by
fluorescent probes. As such, PANDAA-enabled qPCR is an ideal solution for universal detection of pathogens with
significant strain, lineage, and/or sub-type sequence diversity. Aldatu is uniquely positioned to deliver a rapid pan-
filovirus qPCR-based assay that is rapid, sensitive molecular diagnostic for the detection and differentiation of EBOV
and MARV with superior performance compared to existing diagnostics and won’t be affected by genetic changes
in new viral variants. PANDAA has been successfully applied to subtype-independent detection of more than fifteen
drug resistance mutation (DRM) targets in HIV. Recently, we developed the first pan-lineage assay for Lassa fever
virus (LASV), another WHO priority pathogen with high outbreak potential. We propose to leverage the unique
capabilities of PANDAA to develop a rapid, sensitive molecular diagnostic assay for filovirus detection, and the first
with pan-species coverage of EBOV and MARV, through the following specific aims: (1) development of a pan-
filovirus PANDAA assay, leveraging proven techniques and proprietary PANDAA reagent design; (2) analytical
validation including confirmation of species inclusivity and high specificity; (3) multiplexing of the PANDAA-Filovirus
assay with existing assays for LASV and CCHFV to produce a viral hemorrhagic fever (VHF) panel, including the
thermostabilization of the both PANDAA-Filovirus and PANDAA-VHF assays, to meet the requirements of diagnostics
targeted to LMICs; (4) GMP manufacturing of the thermostabilized PANDAA-Filovirus and PANDAA-VHF assays and
(5) assay validation using samples representing a broad variety of circulating species and...

## Key facts

- **NIH application ID:** 10547447
- **Project number:** 1R44AI172551-01
- **Recipient organization:** ALDATU BIOSCIENCES, INC.
- **Principal Investigator:** Iain James MacLeod
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $964,499
- **Award type:** 1
- **Project period:** 2022-08-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10547447

## Citation

> US National Institutes of Health, RePORTER application 10547447, PANDAA for universal, pan-lineage molecular detection of filoviruses to enable rapid epidemic response. (1R44AI172551-01). Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/grant/nih/10547447. Licensed CC0.

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