Explore the latest news on precision diagnostics related innovations from Roche
October 19, 2025
Roche’s Tecentriq showed significant overall and disease-free survival benefits in bladder cancer with ctDNA-guided treatment
In this ctDNA-guided setting, Tecentriq reduced the risk of death (overall survival, OS) by 41% and the risk of disease recurrence or death (disease-free survival, DFS) by 36%, both compared with placebo.
October 15, 2025
Roche presents major advances for its sequencing by expansion technology (SBX), including a new GUINNESS WORLD RECORD™, at the ASHG conference 2025
Following its recent unveiling, SBX is already being recognized by early evaluators in the sequencing community for its combination of speed, flexibility, and longer reads, which significantly expands research possibilities.
October 13, 2025
Roche’s Elecsys® pTau181 becomes the only FDA-cleared blood test for use in primary care to rule out Alzheimer’s-related amyloid pathology
The United States Food and Drug Administration (FDA) has cleared Elecsys pTau181 test, the only blood-based biomarker (BBM) test indicated as an aid in the initial assessment for Alzheimer’s disease and other causes of cognitive decline in the primary-care setting.
September 5, 2025
Roche receives CE IVDR approval for HER2 (4B5) companion diagnostic test to identify HER2-ultralow breast cancer and biliary tract cancer patients
This test is now the first and only companion diagnostic to aid in the assessment of HER2-positive status to identify biliary tract cancer patients with an immunohistochemistry score of 3+ who are eligible for treatment with Jazz Pharmaceuticals’ ZIIHERA® (zanidatamab-hrii).
May 13, 2025
Roche receives FDA approval for the VENTANA MET (SP44) RxDx Assay as the first companion diagnostic to identify non-squamous non-small cell lung cancer patients eligible for treatment with Emrelis
The FDA accelerated approval is supported by data from the Phase 2 LUMINOSITY study, an ongoing study designed to characterize the efficacy and safety of Emrelis in c-Met overexpressing advanced NSQ-NSCLC populations.
May 12, 2025
2025: The future of cancer diagnostics in the pathology lab
Q&A with Katie Robertson, Ph.D., oncology network lead at Roche Diagnostics.
April 28, 2025
Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer
The U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation for the VENTANA® TROP2 (EPR20043) RxDx Device. This is the first Breakthrough Device Designation to be granted for a computational pathology companion diagnostic (CDx) device.
March 21, 2025
Addressing the unmet need in Alzheimer’s diagnostics
Research & development efforts are ushering a range of novel diagnostic tools into the landscape of Alzheimer’s disease care and clinical research.
February 13, 2025
Roche enters into collaboration agreement with PathAI to expand digital pathology capabilities for companion diagnostics
PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology, will exclusively work with Roche Tissue Diagnostics (RTD) to develop AI-enabled digital pathology algorithms in the companion diagnostics space.
January 30, 2025
Roche receives FDA approval for the first companion diagnostic to identify patients with HER2-ultralow metastatic breast cancer eligible for ENHERTU
Until the introduction of HER2-low status in 2022, HER2 status was categorised as either “positive” or “negative” based on the level of HER2 expression. The PATHWAY HER2 (4B5) test has now received approval to identify a new patient population designated as "HER2-ultralow."
November 18, 2024
Roche receives CE Mark for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE
This certification follows the unprecedented decision by regulators to grant an early exemption approval for the test in Germany and Austria earlier this year.
October 21, 2024
Roche receives FDA approval for the first companion diagnostic to identify patients with gastric and gastroesophageal junction cancer eligible for targeted treatment with VYLOY
October 11, 2024
Roche’s VENTANA CLDN18 assay gains CE mark
The qualitative test assesses Claudin 18 protein expression in gastric adenocarcinoma.
November 14, 2022
Roche receives FDA approval for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE
The new test informs clinicians about the likelihood of potential patient benefit from FOLR1 therapy, advancing Roche's commitment to personalised healthcare through innovative solutions that help fit the treatment to the individual.