Half-Year 2022 Financial and Clinical Trials Update
Key launches 2022
Area
Pathology Lab
Product
BenchMark ULTRA PLUS
DP600
Core Lab
Instruments
Molecular Lab
POC
cobasⓇ pure integrated solutions
cobasⓇ 5800
Digital LightCycler
cobasⓇ pulse
HER2 Low Breast
Pathology Lab PRAME
HPV Self Sampling
cobasⓇ HCV Duo
Tests
Core Lab
Elecsys pTau/AB42 ratio Gen2
(CSF)
cobasⓇ SARS-CoV-2 DUO
Molecular Lab
cobas® 5800 Menu Expansion
Chronic Kidney Disease InSight
Cervical Cancer Screening
Lab Insights
Digital
Solutions
cobasⓇ infinity edge suite
Diabetes Care
Lab Insights Platform
Payer Dashboard
mySugar Pump V2.0
Description
Automated immunohistochemistry/in situ hybridization (ISH) advanced staining platform with
enhanced software capabilities, workflow and testing efficiency
High capacity pathology slide scanner for high volume digitization applications
Serum work area analyzer for low-to-medium sized labs
Real-time PCR molecular testing for low volume labs
Novel digital PCR platform for lab developed tests (LDTs) and in-vitro diagnostics labs
Handheld device combining professional Glucose Meter and a digital platform to host Roche owned
and 3rd party digital clinical decision support applications
Assay for diagnosis of HER2 low expression breast cancer
First immunohistochemistry assay for differential diagnosis of benign from malignant melanocytic
lesions in skin cancer
Self sample collection device for patients at home to collect sample for cervical cancer testing
Antigen/antibody combined assay for faster diagnosis of hepatitis C
Detect amyloid disease and enable a broader availability of testing for patients suspected of
Alzheimer's Disease
Automated RT-PCR assay for use on the cobas® 6800/8800 systems
Assays to test for SARS-CoV-2, chlamydia trachomatis (CT)/neisseria gonorrhoeae (NG) and
cytomegalovirus (CMV)
Digital solution (mobile app and dashboard) providing insights for chronic kidney disease patient
management
Digital solution (mobile app and workflow) improving the management of screening programs for
cervical cancer
Portfolio of digital products to support decentralization of testing and data, to launch commercially
with an open ecosystem
Market Status
US & CE
WW
US
US
WW
US
US
US & CE
CE
CE
US
US² & OUS1
US & CE
CE
CE
씽씽
CE
Data integration platform for laboratory customers across disciplines
Population-level insights via dashboard for HCPs, Admins and Payers
Extended functionalities (e.g. temporary basal rate import from a connected insulin pump),
expanded smartphone compatibility
CE
OUS3
OUS3
CE: European Conformity, US: FDA approval, WW: Worldwide including CE, US and China, OUS: Outside the US; PCR: Polymerase Chain Reaction; RT: Real Time; 1 Research Use Only; 2 EUA: Emergency Use Authorization;
3 Only selected countries
Roche
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