# PANDAA for universal, pan-lineage molecular detection of Crimean-Congo Hemorrhagic Fever virus

> **NIH NIH R44** · ALDATU BIOSCIENCES, INC. · 2021 · $865,501

## Abstract

Crimean-Congo Hemorrhagic Fever (CCHF) is a tick-borne disease with high mortality rates in humans and high
outbreak potential. Found in 30 countries across Europe, Asia, and Africa, CCHF has an extremely widespread and
growing range. Its causative agent, CCHF virus (CCHFV), is listed among the urgently concerning pathogens
prioritized in the WHO R&D Blueprint. With at least seven regional clades, CCHFV detection by gold standard qPCR-
based methods has been encumbered by significant strain-associated genetic variability. Existing tests for CCHFV
are often limited to regional use, presenting a barrier to standardization and quality assurance. The WHO has called
for the development of universal CCHFV diagnostics as a global priority. Aldatu Biosciences 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 target-
proximal polymorphisms to allow otherwise divergent templates to be detected with consensus fluorescent probes
with similar sensitivities. 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 Biosciences is uniquely positioned to
deliver a rapid pan-lineage qPCR-based CCHFV diagnostic. PANDAA has been successfully applied to subtype-
independent detection of more than fifteen drug resistance mutation (DRM) targets in HIV. Recently, we completed
development of 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 CCHFV detection, and the first with pan-lineage coverage, through the following
specific aims: (1) development of a pan-lineage PANDAA-CCHFV assay, leveraging proven techniques and
proprietary PANDAA reagent design; (2) analytical validation of the PANDAA-CCHFV assay, including confirmation
of clade inclusivity and high specificity; (3) thermostabilization of the PANDAA-CCHFV assay, in order to meet the
requirements of diagnostics targeted to LMICs; (4) clinical validation of the lyophilized PANDAA-CCHFV assay, using
clinical samples representing a broad variety of circulating clades and geographies; and (5) multi-site evaluation of
the PANDAA qDx CCHFV test kit at reference labs at CDC- and WHO-affiliated partner institutions. As the first pan-
lineage assay, PANDAA-CCHFV will provide a rapid, standardized testing option for all regions within the broad
range of CCHFV. This novel, pan-lineage detection assay could ultimately be deployed in any endemic region on
pre-existing qPCR equipment in central labs, and/or integrated into a closed, point-of-care system with sample
processing to radically improve the CCHFV diagnostic workflow.

## Key facts

- **NIH application ID:** 10157784
- **Project number:** 1R44AI157650-01
- **Recipient organization:** ALDATU BIOSCIENCES, INC.
- **Principal Investigator:** Iain James MacLeod
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $865,501
- **Award type:** 1
- **Project period:** 2021-03-24 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10157784

## Citation

> US National Institutes of Health, RePORTER application 10157784, PANDAA for universal, pan-lineage molecular detection of Crimean-Congo Hemorrhagic Fever virus (1R44AI157650-01). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10157784. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*