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

Altona Diagnostics GmBH

Business Name: Altona Diagnostics GmBH
Business Genre:
Business Description:

With a background in infectious diseases and molecular technoIogies, this company focuses on RT-PCR and other technologies for in vitro diagnostic purposes [2].

State: Hamburg
Country: Germany
Data/Evidence of Effectiveness: N/A
Complimentary Products Needed to Perform Test: Any of the following instruments: Mx3005P QPCR System, VERSANT kPCR Molecular System AD, ABI Prism 7500 SDS, LightCycler 480 Instrument II, Rotor-Gene 6000, Rotor-Gene Q 5/6 plex Platform, CFX96 Deep Well Real-Time PCR Detection System, CFX96 Deep Well Dx System, CFX96 Real-Time Detection System, CFX96 DX System [5].
Setting of Care: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a [3].
Current Status / Clinical Development Stage / Expected Milestones: EUA authorized. Waived current good manufacturing practice requirements [5]. Designed for only in vitro diagnostic use [3].
LOD: 127 [10]
Funding & Ownership : Private, Estimated annual revenue – $5M [8].
Business Model: Offer a range of PCR based technologies with their main product families being the AltoStar (for automated pipetting, and PCR setup/reagents) [6] and RealStar [7].
IP: N/A
History & Origins : Previous experience in molecular diagnostics, particularly in infectious disease [9].
Date EUA Issued: 04/22/2020 [4]
Sources: [1] https://www.altona-diagnostics.com/en/ [2] https://www.altona-diagnostics.com/en/about-us/portrait.html [3] https://www.fda.gov/media/137257/download [4] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [5] https://altona-diagnostics.com/en/products/reagents-140/reagents/realstar-real-time-pcr-reagents/realstar-sars-cov-2-rt-pcr-kit-ruo.html [6] https://www.altona-diagnostics.com/en/products/instrumentation/altostar-am16.html [7] https://www.altona-diagnostics.com/en/products/reagents.html [8] https://www.owler.com/company/altona-diagnostics [9] https://www.altona-diagnostics.com/en/about-us/history.html [10] https://www.fda.gov/media/137252/download
Organization: Ulrich Spengler (Managing Director), Markus Hess (Partner), Thomas Laue (Partner) [9].
No. Tests Per Day: 96* 18 = 1728
Time to Result: Approximately 79 mins based on time instructions for use [10]
Test Sample Type: Nasopharyngeal swabs, oropharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal washes and nasal aspirates [3]
Technology Overview: A reagent based system that is dependent on RT PCR and differentiates itself by the extra confirmation of B-betacoronavirus RNA [5].
Testing Type: Qualitative RT-qPCR test for nucleic acids specific to B-betacoronavirus and SARS-CoV-2 [5].
Test Category: RT-PCR
Test Name: RealStar SARS-CoV-2 RT-PCR Kit U.S.
Clinical Application & Need: Qualitative detection of nucleic acids in specimens obtained from patients suspected of having SARS-CoV-2 [3].
Age of Company: 2007 [8]

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