NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

Business Genre:
Business Description:

Aldatu is currently developing multiple PCR-based disease detection kits using their developed pan-degenerate amplification and adaptation (PANDAA) technology [9].

City: Boston
State: MA
Data/Evidence of Effectiveness: Evaluations summary states 100.0% (95% CI: 95.5% – 100.0%) sensitivity and 98.0% (95% CI: 92.8% – 99.8%) specificity, with a limit of detection of 100 copies/mL [6, 7].
Complimentary Products Needed to Perform Test: PCR equipment and associated sample prep tools [6].
Setting of Care: If EUA is granted, assumed to be clinical research laboratories cerified to perform high complexity tests due to PCR equipment and process required [6, 7].
Current Status / Clinical Development Stage / Expected Milestones: “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.” [8]. For research use only as of 06/04/2020 [1, 6].
LOD: 100 copies/mL [7]
Funding & Ownership : Private [5].Grant funding, raised $4.8M over five funding rounds [5]
Business Model: Aldatu is currently developing PANDAA RT-PCR kits for research and clinical use for detection of several diseases, but none are currently available for clinical use [9].
IP: None found
History & Origins : Founded on January 7, 2014 [5]
Date EUA Issued: No EUA issued [1]. For research use only [6].
Sources: [1] https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization [2]https://www.aldatubio.com/ [3] https://www.aldatubio.com/team/ [4] https://www.aldatubio.com/solution/ [5] https://www.crunchbase.com/organization/aldatu-biosciences [6] http://www.aldatubio.com/wp-content/uploads/2020/04/PANDAA-qDx-SARS-CoV-2-Product-Sheet-2020-04-16-v2.0.pdf [7] http://www.aldatubio.com/wp-content/uploads/2020/05/PANDAA-qDx-SARS-CoV-2-Validation-Data-External-Summary-v2.2.pdf [8] https://www.aldatubio.com/news/aldatu-enables-on-site-covid-19-testing-at-major-boston-hospital/ [9] https://www.aldatubio.com/pipeline/
Organization: David Raiser (Co-Founder, CEO); Iain MacLeod (Co-Founder, CSO); Betsy Wonderly Trainor (VP Development) [3]
No. Tests Per Day: 94 tests/run x 1 run/1hour x 24 hours/day=2256 tests/day
Time to Result: Results in 1-2 hours [4], results from RNA in 1 hour [6], with 94 samples/run [7].
Test Sample Type: Assumed to be upper respiratory samples based on evaluation summary [7].
Technology Overview: Uses a specialized form of RT-PCR developed by Aldatu known as Pan-Degenerate Amplification and Adaptation (PANDAA), which reduces errors and ensures high sensitivity and specificity [7].
Testing Type: Specialized form of RT-PCR
Test Category: RT-PCR
Test Name: PANDAA qDx SARS-CoV-2 [2]
Clinical Application & Need: Qualtitative nucleic acid test [6], assumed to be applicable for detection of active infection based on RNA validation studies [7].
Age of Company: 6 years old, founded in 2014 [5]

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