Phesgo and Tecentriq Performance and Approvals
Diagnostics key launches 2023
Roche
Area
Product
CCM Vertical
Description
Modular transportation system, integrated into the existing cobas connection modules, allowing for overhead
sample transportation over different work areas or different floors enabling effective use of lab space
Markets
Status
Global
Core Lab
cobas pro integrated
solutions
Scalable and modular serum work area analyzer for mid to high volume clinical chemistry and
immunochemistry testing
China
Instruments
Automation
cobas pure integrated
solutions
Serum work area analyzer for low to mid volume clinical chemistry and immunochemistry testing on a
footprint of two square meters
China
Molecular Lab LightCycler Pro
Point of Care
cobas pulse
Pathology Lab IDH1 R132H (IDH Glioma)
Flexible real-time PCR instrument with dual IVD and research mode as well as enhanced system features
Handheld device combining professional glucose meter and a digital platform to host digital clinical decision
support applications (from Roche and third parties)
Neuropathology Immunohistochemistry (IHC) solution supporting the detection of tumor cells with the IDH1
R132H mutation aiding pathologists to render a diagnosis of gliomas
Anti-HEV IgM: Immunoassay aiding in the diagnosis of acute HEV infection in clinical settings; Anti-HEV
Anti-HEV IgG and Anti-HEV IgG: Immunoassay aiding in the detection of a recent or past HEV infection and enabling accurate
IgM
seroprevalence determinations. The two assays expand the hepatitis panel (HAV, HBV, HCV, HEV) on the
same analytical platform
US & CE
US
US
CE
Tests
Core Lab
HBeAg Quant
Immunoassay aiding in diagnosis, monitoring and predicting treatment response for patients with hepatitis B
viral infection
CE
IL-6 Neonatal sepsis (claim Only immunoassay available on the market with dedicated claim and supporting evidence aiding in
extension)
diagnosis of sepsis in neonates, with potential to reduce newborn mortality
RUO Amyloid Plasma
Assays (pTau181 & ApoE4)
RUO Digital Pathology
Algorithm: PD-L1 SP142
navify Algorithm Suite
Menu for navify Algorithm
Suite
Pathology Lab
Digital
Solutions
Lab Insights
cobas infinity lab 3.05
navify Marketplace
navify Sample Tracking
CE
Two qualitative immunoassays measuring the phosphorylated Tau 181 protein and apolipoprotein E4 in
human plasma for research use only
US
Digital pathology algorithm aiding pathologists in scoring PD-L1 (SP142) breast samples, ensuring a
standardized approach and an adjunctive tool to augment diagnostic confidence for research use only
Digital solution providing access to an open library of certified IVD-based clinical algorithms
Certified clinical algorithms for oncology applications such as colon and liver cancers
Next-generation lab middleware enabling ecosystem of cloud-based solutions for quality control and
instrument maintenance
Global
Selected markets1
Selected markets1
Global
Digital marketplace offering lab customers full range of innovative applications (from Roche and third parties) Selected markets¹
Open digital solution offering sample tracking beyond the lab setting (from IVD-sample creation to lab
Selected markets1
reception) to improve testing traceability and quality
1 Selected markets: 14 countries with first releases // CE: European conformity; RUO: Research use only; PCR: Polymerase chain reaction; IVD: In vitro diagnostic; IDH: Isocitrate dehydrogenase; HEV: Hepatitis E virus;
HAV: Hepatitis A virus; HBV: Hepatitis B virus; HCV: Hepatitis C virus
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