Laboratory & Diagnostics

SHERIDAN, WYOMING – June 1, 2025 – Roche has announced compelling final overall survival data from its phase III INAVO120 study, showing that the Itovebi™ (inavolisib)-based regimen reduces the risk of death by more than 30% in patients with PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer. The findings were presented at the 2025 ASCO Annual Meeting and simultaneously published in the New England Journal of Medicine.

First PI3K Inhibitor to Prolong Survival in This Breast Cancer Subtype

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 received FDA approval for Susvimo® (ranibizumab injection) 100 mg/mL as a new treatment for diabetic retinopathy (DR), marking a pivotal advancement in the battle against this vision-threatening condition that affects nearly 10 million Americans.

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 17, 2025 – Danaher Corporation has achieved a historic milestone in genomic medicine, enabling the development and delivery of the world’s first personalized mRNA-based CRISPR therapy for an infant with a life-threatening genetic disorder—in under six months. Powered by the Danaher Business System (DBS), this breakthrough exemplifies how disciplined innovation and cross-company collaboration can dramatically accelerate biopharmaceutical timelines and patient impact.

Compressing an 18-Month Timeline into Six

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.