Aldatu Enables On-site COVID-19 Testing at Major Boston Hospital

(BOSTON, MA) — Despite national supply constraints, one of the major Boston hospitals now has the ability to do rapid in-house testing and they are conducting the highest volume of on-site hospital testing in New England, thanks to Boston-based startup, Aldatu Biosciences.

Less than three weeks ago, the Aldatu team set to work on developing a test for COVID-19 detection. On Tuesday (March 17th), a Boston hospital with zero prior capacity to test for COVID-19 was using Aldatu’s test to process its first 200 patient samples, with plans to increase to nearly 800 tests per day by week’s end.

The test, called PANDAA qDx™ SARS-CoV-2 (or just “PANDAA qDx™”, or even just “PANDAA”, pronounced like the animal), is allowing this large hospital to provide reliable same day COVID-19 testing results for the first time since the start of the coronavirus outbreak, and at a fraction of the cost of what send-out tests (e.g. LabCorp, Quest) charge for 3-7 day turnaround. In addition to finally allowing clinicians to accurately diagnose and manage their patients, the rapid turnaround time of the on-site PANDAA qDx test allows the overburdened hospital to allocate scarce isolation resources more efficiently, and for critical healthcare workers to be screened quickly and regularly.

“Accomplishing this feat on this truly remarkable 18-day timeline is all thanks to an incredible coming together of private sector and academic hospital partners, working efficiently and tirelessly to meet a desperate and critical need in a time of crisis” said David Raiser, CEO of Aldatu.

Within 72 hours of arriving on site:
– Hundreds of patient samples tested using Aldatu’s PANDAA qDx SARS-CoV-2 
Clinically validated using MA Dept. of Public Health blinded panel
– Demonstrated concordance with CDC COVID-19 assay
– Validated as an LDA/LDT and in clinical use on the automated Abbott m2000sp/rt RealTime system; validated in parallel on manual workflows with distinct sample prep and PCR solutions
– Up to 94 clinical results per 6 hr sample-to-answer run
– Test price is fully reimbursable under billing code U0001
– Allows for efficient allocation of scarce hospital isolation resources, and for critical healthcare workers to be screened quickly and regularly

Implementation at additional sites:
Emergency Use Authorization (EUA): Aldatu can provide templates, protocols, and reagents (e.g. in vitro transcribed SARS-CoV-2 RNA) for validation following FDA EUA guidance and dedicated Aldatu support (on-site, if needed) to facilitate the EUA validation process and test implementation
Inventory available immediately to enable on-site testing at additional laboratories

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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.