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In Vitro Diagnostics (IVD)

Roche’s Fenebrutinib Shows Sustained Efficacy in Multiple Sclerosis Over 96 Weeks

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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.

CHMP Recommends EU Approval of Roche’s Itovebi for Advanced Breast Cancer Treatment

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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.

Roche and Broad Clinical Labs Join Forces to Advance Next-Gen Sequencing in Neonatal Care

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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.

FDA Approves Roche’s VENTANA MET (SP44) RxDx Assay as First Companion Diagnostic for Emrelis Treatment in NSCLC

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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

Roche Launches Elecsys PRO-C3 Test to Advance Precision in Liver Fibrosis Diagnostics

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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

Roche Launches Elecsys PRO-C3 Test to Revolutionize Liver Fibrosis Diagnosis

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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.

Roche Receives FDA Breakthrough Device Designation for AI-Driven Lung Cancer Diagnostic

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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.

Thermo Fisher Scientific to Present at BofA Securities 2025 Health Care Conference on May 13

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SHERIDAN, WYOMING – May 8, 2025 – Thermo Fisher Scientific Inc. (NYSE: TMO), a global leader in serving science, has announced that Marc N. Casper, the company’s chairman, president, and chief executive officer, will be presenting at the highly anticipated BofA Securities 2025 Health Care Conference on Tuesday, May 13, 2025, at 11:40 a.m. (ET). The presentation will be available via a live webcast, accessible through the Investors section of Thermo Fisher’s official website.

Agilent Receives European IVDR Certification for Companion Diagnostic Assay in Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

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SHERIDAN, WYOMING – May 8, 2025 – Agilent Technologies Inc. (NYSE: A) has announced that its PD-L1 IHC 22C3 pharmDx (Code SK006) assay has achieved European IVDR certification. This certification positions the assay as a Companion Diagnostic (CDx) to identify gastric or gastroesophageal junction (GEJ) adenocarcinoma patients eligible for treatment with KEYTRUDA® (pembrolizumab), a leading anti-PD-1 therapy developed by Merck.

Bio-Rad Reports First-Quarter 2025 Financial Results: Strategic Adjustments Amid Market Uncertainty

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SHERIDAN, WYOMING – May 8, 2025 – Bio-Rad Laboratories, Inc. (NYSE: BIO and BIO.B), a global leader in life science research and clinical diagnostics products, has announced its financial results for the first quarter of 2025. Despite navigating a challenging macroeconomic landscape, the company demonstrated solid operational performance, underscoring its commitment to driving growth and margin expansion amidst market volatility.