U.S. biotech company Aldatu Biosciences has been awarded a $3 million Direct-to-Phase II Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH).
The award will fund the advancement of the company’s proprietary PANDAA technology platform and its specific application to the detection of Crimean-Congo hemorrhagic fever virus (CCHFV), the causative agent of Crimean Congo hemorrhagic fever (CCHF).
About 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, CCHFV, is listed among the urgently concerning pathogens prioritized in the World Health Organization (WHO) R&D Blueprint.
The WHO said it has a high case fatality ratio (10-40%), potentially results in hospital and health facility outbreaks, and is difficult to prevent and treat. CCHF is endemic in all of Africa, the Balkans, the Middle East and in Asia.
Universal diagnostics a ‘global priority’
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.
PANDAA assays mitigate target-proximal variability without sacrificing specificity, and as such can address a critical issue for CCHFV diagnostics.
“Traditional qPCR falls short when it comes to development of simple assays with broad coverage of genetically diverse subtypes or lineages of the same pathogen, but this is exactly where PANDAA excels,” said Iain MacLeod, CEO/CSO at Aldatu Biosciences.
“This funding will enable us to further demonstrate the unique ability of the PANDAA platform to solve diagnostic challenges related to strain variability that have plagued the diagnostic community for ages.”
Global potential for Aldatu Biosciences’ solution
The focus of this Direct-to-Phase II SBIR work will be to develop a simple, qPCR-based assay capable of detecting all circulating CCHFV lineages with a time-to-result of less than two hours. As the only test that would detect all circulating CCHFV lineages with equally high sensitivity, the PANDAA CCHFV test in development would provide a first-in-kind scalable commercial solution that could be applied globally.
As the WHO and other global health leaders continue to support response efforts for viral hemorrhagic fever outbreaks globally, new tools that increase access to quality testing and support disease management are leading discussions, especially when effective vaccines and therapy are lacking.
“We are pleased to grow our Pandemic Preparedness Portfolio with our CCHFV test joining our tests for SARS-CoV-2 and Lassa Fever Virus,” said Mike Henry, Aldatu Biosciences’ CBO.
“Genetic diversity is a common theme among recent viral outbreaks, including the COVID-19 pandemic which we are still navigating today. Our PANDAA technology is designed to enable simple and fast detection of these highly divergent viruses on common diagnostic laboratory instruments like the ABI 7500 or the Abbott m2000, which are great tools when responding to outbreaks, as they are located in abundance across the globe.”