In Vitro Diagnostics (IVD)

SHERIDAN, WYOMING – July 29, 2025 – Roche is accelerating its multi-modal approach to Alzheimer’s disease, unveiling new data at the Alzheimer’s Association International Conference (AAIC) that spotlight the therapeutic potential of trontinemab and the diagnostic promise of its Elecsys® pTau217 blood test. Together, these innovations signal a possible shift toward earlier, more accessible, and more precise detection and treatment of the world’s most prevalent neurodegenerative disease.

Trontinemab shows rapid amyloid clearance with low ARIA risk

SHERIDAN, WYOMING – July 29, 2025 – Bio-Rad Laboratories has named Rajat Mehta as its new Executive Vice President of Global Commercial Operations, signaling a strategic push to accelerate growth across its diagnostics and life sciences business lines. Mehta, whose appointment takes effect August 4, 2025, brings broad cross-sector expertise and a proven track record of commercial execution in the biopharma and scientific instrumentation industries.

New commercial leadership aimed at scaling global market impact

SHERIDAN, WYOMING – July 25, 2025 – Roche has received CE Mark certification for its Elecsys® pTau181 blood test, marking a pivotal advancement in Alzheimer’s diagnostics by introducing the first IVDR-certified in-vitro diagnostic test to help rule out Alzheimer’s-associated amyloid pathology.

SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling new data from its ongoing FENopta open-label extension study, confirming that its investigational therapy fenebrutinib continues to provide sustained disease suppression in patients with relapsing multiple sclerosis (RMS) for up to two years.

SHERIDAN, WYOMING – May 27, 2025 – Roche has received a significant endorsement from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which issued a positive opinion for Itovebi™ (inavolisib) in combination with palbociclib and fulvestrant. This recommendation positions Roche to offer a first-line treatment solution for adult patients with PIK3CA-mutated, ER-positive, HER2-negative, locally advanced or metastatic breast cancer—an area with limited current treatment options.

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced a new strategic collaboration with Broad Clinical Labs, aiming to accelerate the adoption of its next-generation Sequencing by Expansion (SBX) technology, with an initial focus on trio-based whole genome sequencing for critically ill newborns and their biological parents. The partnership signifies a pivotal move in expanding genomics-enabled healthcare and precision medicine at scale.

SHERIDAN, WYOMING – May 27, 2025 – Roche has announced FDA approval of its VENTANA® MET (SP44) RxDx Assay, marking a major milestone in companion diagnostics for non-small cell lung cancer (NSCLC). This approval paves the way for a more precise identification of patients eligible for AbbVie’s Emrelis™ (telisotuzumab vedotin-tllv), a targeted therapy for non-squamous NSCLC with MET protein overexpression.

Enhancing Treatment Precision in Lung Cancer Care

SHERIDAN, WYOMING – May 27, 2025 – Roche has introduced its Elecsys® PRO-C3 diagnostic test, marking a major step forward in the assessment of liver fibrosis severity, particularly in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). With the ability to deliver results in just 18 minutes, the new test is poised to streamline diagnostics and enable earlier, more accurate clinical decision-making.

Strategic Response to a Global Health Burden

SHERIDAN, WYOMING – May 8, 2025 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today introduced the Elecsys® PRO-C3 test, a groundbreaking diagnostic solution designed to assess liver fibrosis severity in patients with metabolic dysfunction–associated steatotic liver disease (MASLD). This innovative test, developed in partnership with Nordic Bioscience, provides healthcare providers with a fast and efficient way to evaluate liver fibrosis, a disease that contributes to one in every 25 deaths globally.

SHERIDAN, WYOMING – May 8, 2025 – Roche has achieved a significant milestone in oncology diagnostics with the U.S. Food and Drug Administration (FDA) granting Breakthrough Device Designation for its VENTANA® TROP2 (EPR20043) RxDx Device. This marks the first FDA recognition for a computational pathology companion diagnostic (CDx) device using artificial intelligence, highlighting Roche's continued leadership in cancer diagnostics and precision medicine.