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].
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] [2] [3] [4] [5] [6]”
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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