(BOSTON, MA) — 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 $300K Phase I 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 Lassa virus, the causative agent of Lassa fever.

Each year there are between 100,000-300,000 known Lassa fever infections, resulting in at least 5,000 associated deaths. A recent outbreak in Nigeria (January 2018) had a daunting 25% case fatality rate. Current standard clinical testing yields high false negative rates due to the high genomic diversity of circulating Lassa lineages. Consequently, the clinical algorithm is cumbersome and requires that two tests be run in succession in order to confirm a negative diagnosis during an outbreak. The high level of complexity, cost, and long turnaround time for results of available tests makes testing for Lassa virus infection inaccessible to many vulnerable populations.

PANDAA assays uniquely mitigate target-proximal variability without sacrificing specificity, and as such can address a critical issue for Lassa 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, 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 Phase I SBIR work will be to develop a simple, qPCR-based assay capable of detecting all circulating Lassa virus lineages with a time-to-result of less than 2 hours. As the only test that would detect all circulating Lassa lineages with equally high sensitivity, the PANDAA-based test in development stands to reduce the current diagnostic algorithm from two tests to one. With increased access to new tools that enable significant time and cost savings – both critical during viral hemorrhagic fever outbreaks – earlier detection of Lassa fever infection could significantly decrease the spread of infection during future outbreaks. 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 testing and decrease transmission are leading discussions, especially when effective vaccines and therapy are lacking.

The launch of the Lassa program marks a significant moment for Aldatu. “Historically, we have been highly focused on the application of PANDAA to drug resistance testing in HIV, one of the most genetically variable pathogens around,” said David Raiser, Aldatu’s CEO. “With more than 20 assays developed, our PANDAA qDx HIVDR product pipeline maturing, and our first products coming to market this year, we are eager to grow beyond HIV and demonstrate the true platform potential of PANDAA. Given the current unmet need and diagnostic gaps in Lassa fever detection, it’s a natural fit for our first non-HIV program.” Raiser also noted that Aldatu has a number of additional development programs in the concept phase.

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Aldatu Biosciences
Aldatu Biosciences is a Boston area-based early-stage biotechnology company developing innovative diagnostic tools based on its proprietary qPCR-enabling platform, PANDAA™. Aldatu is committed to commercializing products that address diagnostic challenges in around the world and which improve both the quality of patient care and healthcare cost-efficiency.

Aldatu is a current resident of Arsenal Lab Space (Watertown, MA), a former resident of the Pagliuca Harvard Life Lab and LabCentral, and a graduate of the MassBio MassCONNECT program. Inquiries can be sent to change@aldatubio.com.