Roche Hldg Stock Price, News & Analysis

The World Health Organization (WHO) has granted prequalification designations for Roche's cobas HPV test on the cobas 5800 System and for self-collected samples on the cobas 5800, 6800, and 8800 Systems.

This follows the U.S. FDA's recent approval of Roche’s HPV self-collection solution and a previous WHO prequalification for the cobas HPV test on the cobas 6800/8800 Systems.

Prequalification allows low- and middle-income countries (LMICs) to integrate these screening tools into national cervical cancer elimination programs, aiming to increase access and reduce cervical cancer incidences. This initiative is significant given that over 600,000 women are diagnosed with cervical cancer annually, leading to over 340,000 deaths. Notably, 90% of these deaths occur in LMICs.

Roche partners with over 55 countries, including Peru, to enhance HPV screening. Through these efforts, hundreds of thousands of women, particularly in underserved regions, have received important HPV testing.

Roche has received approval from the European Commission for the subcutaneous (SC) administration of OCREVUS (ocrelizumab) for treating relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). This new method offers a 10-minute injection that maintains the twice-yearly schedule of the previously approved intravenous (IV) infusion. The approval is based on Phase III OCARINA II trial data, demonstrating comparable efficacy and safety between the SC and IV formulations. This approval aims to enhance patient accessibility and reduce dependence on IV facilities. Roche is collaborating with European health systems to expedite patient access to OCREVUS SC.

Roche has launched new high-capacity analytical units, cobas c 703 and cobas ISE neo, for the cobas pro integrated solutions, targeting laboratories in CE mark regions.

The cobas c 703 analytical unit doubles the throughput to 2,000 tests per hour and offers 70 reagent positions, significantly boosting clinical chemistry testing efficiency. The cobas ISE neo unit enhances ion selective electrode testing with up to 1,800 tests per hour and features automated maintenance, reducing manual intervention.

These units are designed to address challenges like staff shortages and space limitations, offering increased automation and efficiency to improve lab workflows and patient care.

Roche has launched the VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail assay, the first clinically approved highly-sensitive in-situ hybridisation (ISH) test to diagnose B-cell lymphoma. This test helps distinguish B-cell cancers from normal immune responses, providing diagnostic certainty for healthcare providers. B-cell lymphoma accounts for about 85% of non-Hodgkin lymphoma (NHL) cases, the tenth most common cancer globally. This CE Mark-approved test can identify over 60 B-cell lymphoma subtypes and plasma cell neoplasms using a single tissue slide, reducing the need for fresh tissue samples and additional biopsies. The assay is part of Roche’s extensive hematopathology portfolio.

Roche announced that its VENTANA DP 200 digital pathology solution has received FDA 510(k) clearance for diagnostic use. This clearance allows pathologists to use digital images for primary diagnosis, enhancing healthcare efficiency and patient care, especially in remote areas. The solution includes a slide scanner, workflow software, and a display, aiming to streamline digital pathology workflows. By enabling timely diagnoses from anywhere, this innovation supports greater pathologist collaboration and improved lab efficiency. Roche emphasizes its commitment to digital transformation and AI-based tools in pathology.

Roche's Phase III STARGLO study of Columvi (glofitamab) in combination with GemOx chemotherapy shows promising results for relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The study met its primary endpoint, with a 41% reduction in the risk of death compared to R-GemOx. Key secondary endpoints were also met, with a 63% reduction in the risk of disease progression. Median overall survival was 25.5 months for the Columvi combination, nearly double that of R-GemOx. Safety profiles were consistent with known data. Results will be submitted to global health authorities including the FDA and EMA.

Roche has received U.S. FDA Emergency Use Authorization (EUA) for its cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. This four-in-one molecular test utilizes PCR technology for rapid and accurate detection of these viruses within 20 minutes. It requires a single nasal-swab sample, making it suitable for various healthcare settings such as emergency departments and urgent care facilities. The test aims to facilitate swift clinical decision-making, reduce unnecessary antibiotic use, and enhance patient outcomes. Future plans include seeking FDA 510(k) clearance and a CLIA waiver in the U.S., as well as commercial launches in other markets post CE-IVDR approval.

The European Commission has approved Roche’s Alecensa (alectinib) as the first targeted adjuvant treatment for ALK-positive early-stage lung cancer. This approval, backed by Phase III ALINA study data, showed a 76% reduction in the risk of disease recurrence or death compared to chemotherapy. Alecensa is now available for patients with resected stage IB to IIIA ALK-positive non-small cell lung cancer (NSCLC). The ALINA study also showed improved central nervous system disease-free survival. The safety profile of Alecensa remains consistent with prior studies. This approval follows the FDA's approval in April 2024, with global submissions ongoing.

Roche announced five-year data for Evrysdi (risdiplam) showing significant efficacy in treating children with Type 1 spinal muscular atrophy (SMA). The FIREFISH study revealed that 91% of children were alive, with 81% surviving without permanent ventilation. Motor skills improvements were noted, with 59% able to sit unaided for at least 30 seconds, and some able to stand or walk with or without support. The study also showed high rates of maintaining swallowing and feeding abilities. Evrysdi is now approved in over 100 countries, treating more than 15,000 patients globally. No treatment-related adverse events led to discontinuation, and adverse event rates decreased over the study period.