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

Roche Molecular Diagnostics

Business Name:
Roche Molecular Diagnostics
Business Genre:
Business Description:

founded in early 1990s following the development of PCR technology, 1400 people working from five locations in US and Switzerland, focusing on medical diagnositc product development [1]

City:
Pleasanton
State:
CA
Country:
USA
Data/Evidence of Effectiveness:
Qualitative assay description from FDA requires proper sample collection and postive/negative control for the diagnositcs. Internal Control in the diagnostics kit may help identify invalid and false negative results caused by interference. Non-clinical evaluation indicates 0.007 TCID50/mL 95% hit rate for SARS-CoV-2 and 0.004 TCID50/mL 95% hit rate for pan-Sarbecovirus. Clinical samples evaluation shows 100% agreement for both postive and negative samples. [3]
Complimentary Products Needed to Perform Test:
cobas SARS-CoV-2 test kit, cobas SARS-CoV-2 control kit, cobas buffer negative control kit, cobas omni reagents for sample preparation, materials and consumables for use on cobas 6800/8800 system [4]
Setting of Care:
use only under EUA in U.S. laboratories certified under CLIA to perform moderate/high complexity test by clincal personnel trained on cobas 6800/8800 personnel [3]
Current Status / Clinical Development Stage / Expected Milestones:
“Not FDA cleared/approved; authorized by FDA under EUA; authorized only for SARS-CoV-2 nucleic acid detection [3] Begin shipping to US laboratories on March 13; 8 million tests per month worldwide [5]”
Funding & Ownership :
Public (Market Cap $309.542B) [6]
Business Model:
Design and produce infectious disease detection kits [3], sold directly by Fast Track Diagnostics/Siemens Healthineers [6].
IP:
N/A
History & Origins :
the division was founded following the development of PCR technology and had long-lasting experiences in diagnostics prodcuts development. The testing kit is based on fully automated cobas 6800/8800 platform developed by the company previously [1]
Date EUA Issued:
3/12/2020 [2]
Sources:
“[1] https://diagnostics.roche.com/global/en/about/roche-molecular-diagnostics.html [2] https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations [3] https://diagnostics.roche.com/us/en/products/params/cobas-sars-cov-2-test.html [4] https://www.fda.gov/media/136049/download [5] https://diagnostics.roche.com/us/en/landing-pages/general-information-cobas-sars-cov-2-coronavirus-test.html#molecular [6] https://finance.yahoo.com/quote/RHHBY/”
Organization:
Thomas Schinecker (CEO Roche Diagnostics)
Time to Result:
384 results (cobas 6800 System) and 1056 results (cobas 8800 System) in 8 hours[5]
Test Sample Type:
nasal, nasopharyngeal and oropharyngeal specimens [4]
Technology Overview:
dual target PCR detection for SARS-CoV-2 and pan-Sarbecovirus RNA signature [3]
Testing Type:
real-time RT-PCR detection for SARS-CoV-2 nucleic acid[3]
Test Category:
RT-PCR
Test Name:
cobas SARS-CoV-2[3]
Clinical Application & Need:
detect SARS-CoV-2 and pan-Sarbecovirus infection [4]

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