Roche Pharmaceutical Development and Sales Overview
Key launches 2022
Area
Pathology Lab
Core Lab
Instruments
Molecular Lab
POC
Product
BenchMark ULTRA PLUS
DP600
cobasⓇ pure integrated solutions
cobas® 5800
Digital LightCycler
cobasⓇ pulse
HER2 Low Breast*
Pathology Lab PRAME**
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
Roche
Market Status
US & CE
WW
US
US
WW
US
66
US
US & CE
HPV Self Sampling
cobasⓇ HCV Duo
Tests
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
CE
CE
Core Lab
Elecsys pTau/AB42 ratio Gen2
(CSF)
Detect amyloid disease and enable a broader availability of testing for patients suspected of
Alzheimer's Disease
US
cobasⓇ SARS-CoV-2 DUO
Molecular Lab
cobasⓇ 5800 Menu Expansion
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 providing insights for chronic kidney disease patient management
US² & OUS1
> > > >
US & CE
Navify Kidney Companion
Cervical Cancer Screening
CE
Lab Insights
Digital
Solutions
cobas® infinity edge suite
Digital solution 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
CE
CE
Navify Core Integrator
Data integration platform for laboratory customers across disciplines
CE
Payer Dashboard
Population-level insights via dashboard for HCPs, Admins and Payers
OUS3
Diabetes Care
mySugr Pump V2.0
Extended functionalities (e.g. temporary basal rate import from a connected insulin pump),
expanded smartphone compatibility
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; *HER2 Low Breast received FDA approval on 4 Oct 2022; **PRAME launched on 11 Oct 2022
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