BOSTON, Sept. 12, 2022 /PRNewswire/ -- Aldatu Biosciences, a biotechnology company developing molecular diagnostic assays and products based on gold standard real-time PCR, today announced it 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 continued advancement of the company's proprietary PANDAA™ technology platform and its specific application to the universal, pan-lineage detection of Crimean-Congo Hemorrhagic Fever Virus (CCHFV), the causative agent of Crimean Congo Hemorrhagic Fever (CCHF).

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. 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 uniquely 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," noted Iain MacLeod, CEO/CSO at Aldatu. "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."

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 2 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.

The launch of the CCHFV program is another meaningful expansion of the Pandemic Preparedness Portfolio at Aldatu Biosciences. "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's 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."

Aldatu Biosciences is the leader in adaptive PCR diagnostics for global health and emerging diseases. Developed at Harvard University, our proprietary PANDAA™ technology is an innovative pandemic preparedness and biosecurity platform for target detection in highly variable genomic regions. As a Public Benefit Corporation, Aldatu is committed to commercializing diagnostics that improve patient care and healthcare cost efficiency around the world.

Inquiries can be sent to change@aldatubio.com.