2025 in review: Advancing diagnostics through total integrated solutions
Strengthening patient care through science, simplicity and partnership
December 12, 2025
In 2025, we focused on delivering Total Integrated Solutions, combining a comprehensive portfolio of assays, instruments and automation with expert service and the digital connectivity that runs through them all. This strategy empowers us to expand our impact significantly – most notably through a $550 million investment that secures innovative CGM monitoring access for the global diabetes community. Discover how our comprehensive approach is streamlining workflows for our partners and defining the future of U.S. diagnostics.
Transformative science
Our commitment to science drives breakthrough assays and innovation. In 2025, we rapidly expanded capabilities, launching the Elecsys pTau181 to rule out Alzheimer’s pathology and the first FDA-cleared blood test measuring Lp(a) in molar units. We also brought diagnostics closer to the patient with the launch of cobas® liat CT/NG & MG, delivering trusted STI testing at the point of care. Altogether, we released 45 new and updated assays, significantly expanding diagnostic capabilities across multiple platforms.
Efficiency made simple
Providing reliable, quicker diagnostics remains the core of our design. We are driving efficiency and elevating patient care with more than 1,500 digital placements in our navify® ecosystem. Alongside this digital expansion, the FDA-cleared VENTANA® DP 600 scanner now aids high-volume diagnosis using digital images. Additionally, the cobas® i 601 achieved its first CLIA 'Moderate Complexity' categorization for the Vitamin D test, setting the stage for a broader range of clinical labs having access to mass spectrometry technology in 2026.
Comprehensive support and proactive service
We view partnership as the foundation for transformative healthcare. Our dedication to service excellence was recognized with 7 IMV ServiceTrak awards for Chemistry and Integrated Workstation Systems. Building on this trust, we worked alongside world-class healthcare providers to earn the distinction of being named the No. 1 recommended pathology lab partner,1 proving that collaboration continues to drive meaningful change.
Core Lab
Elecsys® pTau181 plasma Alzheimer’s assay receives FDA clearance
The only blood-based biomarker (BBBM) test indicated as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary-care setting.
Roche claims seven of nine 2025 IMV ServiceTrak Awards at ADLM
Roche honored with 2025 IMV ServiceTrak Clinical Laboratory Awards at ADLM for Customer Satisfaction, System Performance, and Service Performance in Core Lab.
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FDA clears Elecsys sFlt-1/PlGF ratio for preeclampsia risk prediction
The ratio is a prognostic test intended to stratify hospitalized pregnant women with hypertensive disorders of pregnancy into low- and high-risk categories for developing severe preeclampsia within two weeks of testing.
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Roche receives FDA clearance for first Tina-quant Lipoprotein (a) Gen.2 Molarity assay
This is the first 510(k) cleared test of its kind available in the U.S. measuring lipoprotein (a), or Lp(a), in nanomoles per liter (nmol/L) to help assess cardiovascular risk.
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Molecular Lab
Discover the future of sequencing, Roche’s Sequencing by expansion (SBX) technology*
Introducing SBX technology, a versatile, high-throughput, single-molecule sequencing technology for a variety of applications.
*The SBX technology and analysis tools are in development and not commercially available in the U.S. The content of this material reflects current study results or design goals.
Roche’s first respiratory test powered by TAGS technology receives FDA clearance for SARS-CoV-2, Influenza A, Influenza B and RSV
This is the first FDA-cleared assay utilizing Roche’s innovative TAGS (Temperature-Activated Generation of Signal) technology, designed to streamline respiratory testing, and to ensure timely and accurate diagnoses for patients.
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Quest Diagnostics Introduces HPV Specimen Self-Collection for Cervical Cancer Screening
The new offering utilizes the FDA-cleared HPV self-collection solution from Roche, approved for use with Roche's cobas® HPV test.
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Introducing the KAPA RNA EvoPrep Kit, the next evolution in RNA library preparation
Building on the robust foundation of the widely used KAPA RNA HyperPrep Kit, this new solution offers a streamlined and efficient workflow for your sequencing needs.
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Near Patient Care
A New Era in STI Testing
Roche launches cobas® liat CT/NG and cobas® liat CT/NG/MG, bringing trusted sexual health testing to the point of care. The cobas® liat STI panel assays deliver fast, accurate results for all genders, providing confidence in sexual health status.
One Visit. One Test. Multiple Results.
Roche achieves FDA 510(k) clearance for cobas® SARS-CoV-2, Influenza A/B & RSV assay. The cobas® liat SARS-CoV-2, Influenza A/B & RSV assay helps streamline testing and enables confident treatment decisions when and where it’s needed the most.
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POC test for the detection of Bordetella infections receives FDA 510(k) clearance and CLIA waiver
The groundbreaking PCR test uses the cobas® liat system to deliver results in just 15 minutes at the point of care and detects and differentiates between three types of Bordetella pathogens that can cause similar cough symptoms.
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Market leader in blood glucose monitoring
With nearly 50 years of expertise in diabetes care, Roche is proud to stand as the leading manufacturer of blood glucose monitoring (BGM) solutions in the U.S. market. This milestone allows us to significantly expand access to our Accu-Chek portfolio, bringing exceptional accuracy, reliability, and support to more people living with diabetes than ever before.
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Pathology Lab
Introducing the VENTANA® MET (SP44) RxDx Assay
The first FDA-approved immunohistochemistry (IHC) assay to identify patients with non-squamous, non-small cell lung cancer (NSQ-NSCLC) who are eligible for MET-targeted treatment with Emrelis™ (telisotizumab vedotin).
Groundbreaking launch of the VENTANA® Kappa and Lambda Dual ISH mRNA Probe Cocktail
The first clinically approved, highly sensitive in-situ hybridization (ISH) test with the sensitivity to assess the full spectrum of B-cell lymphoma subtypes.
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The first and only FDA-Approved assay for HER2-ultralow expression
PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody is the only FDA-approved CDx for HER2-low and ultralow expression. It is FDA approved as a companion diagnostic for the breakthrough designated therapy ENHERTU® (fam-trastuzumab deruxtecan-nxki).
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HER2 (4B5) Breast Cancer Algorithm by navify® Digital Pathology Version 2.0*
This new image analysis algorithm was developed by a team of experts at Roche, including pathologists who took part in DESTINY Breast-04 and DESTINY Breast-06 clinical trials, as a part of a complete end-to-end system, designed to minimize variability and streamline your research workflows.
*For research use only. Not for use in diagnostic procedures
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Disclaimers
- Global Customer Experience (CX) Benchmarking Study 2024