As first-ever Marburg outbreak in Tanzania evolves, Aldatu leads the way with pan-filovirus testing for universal access.

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(BOSTON, MA) —Aldatu Biosciences, a biotechnology company developing gold standard molecular diagnostic assays and based 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 first universal, pan-filovirus detection and differentiation of Ebolavirus and Marburgvirus, the causative agents of Ebola Virus Disease and Marburg Virus Disease.

There is an urgent global unmet market need for a standardized, commercially available pan-species filovirus test that is accessible to resource-limited settings, especially considering the growing reach of the filovirus family as evidenced by the first-ever outbreak in Tanzania that was reported on March 21, 2023.  With a case fatality rate of 88%, Marburg is one of the deadliest of the hemorrhagic fevers. The WHO reported that the 2014-2016 Ebola epidemic in West Africa generated more than 28,000 cases and more than 11,000 deaths in Guinea, Liberia, and Sierra Leone and the CDC reported that more than $3.6 billion was spent to fight the epidemic.

Challenges associated with filovirus biology have previously limited the performance of qPCR in filovirus diagnostics. Many filovirus tests are lab-developed tests and are not available for broad commercial use.  Also, current RT-PCR LDTs are only able to detect regionally endemic clades.

“There are a limited number of commercial tests available, but they do not meet the clinical and market needs laid out in The WHO R&D Blueprint,” says Iain MacLeod, CEO/CSO of Aldatu. “The “sample-in/answer-out” format of PANDAA qDx Filovirus will require minimal sample handling and minimal training on the part of the end user, which are especially important considerations in resource-limited settings.”

Additionally, Aldatu’s PANDAA qDx tests do not require the purchase of any new machinery, taking advantage of the existing infrastructure in centralized testing labs (i.e., Abbott m2000, Roche Lightcycler).  With limited lab space and personnel available in endemic regions of the world, this is key to the adoption of new technology.

However, the most distinct advantage of Aldatu’s innovation is the durability of the PANDAA qDx filovirus tests as the virus continues to evolve and undergo regional genetic reassortment over time.  The unique ability of the PANDAA technology to mitigate the presence of de novo polymorphisms that may arise in the assay primers and/or probe-binding sites will make the PANDAA tests resilient to these potential changes in the selected filovirus target regions.   

The focus of this Direct-to-Phase II SBIR work will be to develop a simple, qPCR-based assay capable of detecting all circulating Ebolavirus and Marburgvirus lineages with a time-to-result of less than 2 hours. As one of the only commercially available tests that would detect all circulating lineages with equally high sensitivity, the PANDAA qDx filovirus 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 are currently responding to the first ever Marburg virus outbreak in Tanzania, it is imperative that affordable, high-quality tools that leverage existing laboratory infrastructure are a priority for pandemic preparedness programs, especially when effective vaccines and therapy are lacking,” says MacLeod.

The launch of the filovirus program is another meaningful expansion of the Pandemic Preparedness Portfolio at Aldatu Biosciences.  “We are pleased to grow our Pandemic Preparedness Portfolio with our filovirus test joining our tests for SARS-CoV-2, Lassa fever virus, and Crimean-Congo hemorrhagic fever virus tests,” 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 tests are designed to enable simple and fast detection of these highly divergent viruses on common diagnostic laboratory qPCR instruments like the ABI 7500 or the Abbott m2000, located in abundance across the globe.”

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About Aldatu: Aldatu Biosciences is the leader in adaptive PCR diagnostics for global health and emerging diseases.  Developed at Harvard University, our proprietary PANDA 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.

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