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

Crimean-Congo hemorrhagic fever virus (CCHFV) is a global health threat due to the widespread and expanding geographical distribution of the tick vector, the absence of specific medical interventions for treatment and prevention, and its rapid-onset hemorrhagic fever with a 10-50% case-fatality rate. It is the most geographically widespread tickborne virus and the causative agent of Crimean-Congo hemorrhagic fever (CCHF), one of the most severe zoonotic viral diseases in humans. Undifferentiated febrile illness is among the most common reasons for people seeking medical care in resource-limited countries, and CCHF is difficult to diagnose in its early pre- hemorrhagic stages due to non-specific symptoms that can be associated with various febrile illnesses. To address this, we developed PANDAA CCHFV-the first universal, pan-lineage CCHFV diagnostic to meet the WHO R&D blueprint target product profile-during our SBIR Phase II. Aldatu's pioneering PANDAA technology enables probe- based qPCR for target detection in highly variable genomic regions by simultaneously adapting and amplifying diverse viral variants. PANDAA uniquely mitigates the presence of genetic polymorphisms in viral variants to allow the detection of otherwise divergent targets by fluorescent probes. As such, we are distinctly positioned to commercialize the first rapid, sensitive molecular CCHFV diagnostic assay with pan-lineage coverage and superior performance compared to existing diagnostics that won't be affected by genetic changes in new viral variants. Through these Phase IIB milestones, we will establish regulatory and quality frameworks for manufacturing and commercializing PANDAA CCHFV as a rapid and sensitive molecular assay with superior performance to existing diagnostics. We will expand our existing quality management system (QMS), which is compliant with international standards for medical device manufacturing, to incorporate in-house cGMP manufacturing of PANDAA CCHFV. With our evaluation partners, we will perform pre-commercialization studies in multiple high-priority markets to determine performance using clinical samples from all CCHFV clades. This will generate the necessary data to submit PANDAA CCHFV for CE certification as an in vitro diagnostic (IVD). This will be accompanied by implementing our initial go- to-market strategy in 3-5 short list countries. We will have identified and vetted clinical study partners, distributors, and other regional partners to support Aldatu in negotiations and contracting with local partners and facilitating engagement with Ministries of Health. We will precede our go-to-market launch with early site evaluations by collaborators in key target markets where they will perform concordance studies with existing CCHFV assays. The net result will be the manufacturing and regulatory qualification of PANDAA CCHFV, which will provide a rapid, standardized testing option-deployable using pre-existing qPCR equipment in central labs in CCHFV-endemic regions-to radically reduce CCHFV diagnostic test complexity, time burden and costs without sacrificing accuracy.