ROCHE HOLDING LTD S/ADR - RHHBY STOCK NEWS

Roche's recent data from the IMPACT trial highlights the benefits of using the CINtec PLUS Cytology test for women at higher risk of cervical cancer. The trial, involving over 35,000 women, demonstrated that this dual-stain biomarker technology significantly outperforms Pap cytology in detecting cervical pre-cancer in HPV-positive women. With over 604,000 cervical cancer diagnoses globally each year, Roche aims to provide clinicians with effective tools to combat this preventable disease, emphasizing the importance of HPV screening.

Roche and Zur Rose Group have partnered to enhance diabetes management for 60 million Europeans living with the condition. The collaboration aims to provide people with diabetes and their caregivers with an integrated suite of services, including telemedicine, self-management products, and data visualization tools. Launching first in Germany in 2022, the program will target type 2 diabetes, which comprises 90% of cases. This venture positions Roche as a leader in personalized diabetes care, leveraging technology to improve patient outcomes and streamline care processes.

Roche has launched the AVENIO Tumor Tissue Comprehensive Genomic Profiling (CGP) Kit, marking a collaboration with Foundation Medicine. This first-of-its-kind kit allows research scientists to conduct genomic profiling in-house, facilitating deeper insights into cancer biology. The product aims to enhance personalized healthcare by broadening access to CGP, which will play a pivotal role in future clinical decision-making. The kit can analyze 324 cancer-related genes, completing the workflow in just five days, and will be available globally.

Roche announced FDA approval for Susvimo (ranibizumab injection), the first alternative to monthly eye injections for treating neovascular age-related macular degeneration (nAMD) in 15 years. Susvimo's implant allows for continuous drug delivery, potentially reducing treatment frequency to just two times a year. It serves approximately 20 million global nAMD patients. The FDA's decision was based on the positive Archway study, showing Susvimo maintained vision gains similar to monthly injections, although it posed a higher risk of endophthalmitis.

Roche has received FDA approval for the VENTANA PD-L1 (SP263) Assay as a companion diagnostic for Tecentriq in non-small cell lung cancer (NSCLC). This test identifies patients likely to benefit from Tecentriq after surgery and chemotherapy, aiming to improve personalized healthcare. The IMpower010 study indicated a 34% reduction in disease recurrence among patients with PD-L1 expression. Lung cancer accounts for over 2.2 million new diagnoses globally each year, reinforcing the importance of such advancements in treatment options.

Roche reported an 8% increase in group sales to CHF 46.7 billion for the first nine months of 2021, driven by strong demand for COVID-19 tests and growth in recently launched medicines. The Diagnostics Division experienced a remarkable 39% growth in sales, while the Pharmaceuticals Division sales remained stable. Key highlights included FDA approvals for Tecentriq and faricimab, and Breakthrough Therapy Designation for gantenerumab. Roche also raised its sales outlook for 2021, anticipating mid-single digit growth. The company's robust product pipeline includes 17 compounds in late-stage development.

Roche has partnered with Ibex Medical Analytics to enhance digital pathology using AI-based tools focused on cancer diagnostics. This collaboration aims to integrate Ibex's advanced image analysis capabilities into Roche's NAVIFY Digital Pathology platform. The partnership will enable pathologists to improve diagnostic efficiency and accuracy, particularly in breast and prostate cancer detection. Ibex's Galen™ platform has recently received FDA Breakthrough Device Designation, increasing confidence in the technology. Roche remains committed to advancing pathology through innovative partnerships and solutions.

Roche has received FDA approval for Tecentriq as the first cancer immunotherapy for the adjuvant treatment of Stage II-IIIA NSCLC. The decision follows the Phase III IMpower010 study, demonstrating a 34% reduction in disease recurrence risk for patients with PD-L1≥1% tumors compared to best supportive care. This approval introduces new treatment options for patients, marking a significant milestone in lung cancer therapy. Tecentriq is currently available in multiple dosing options and has shown clinical benefits across various lung cancer types.

Roche has partnered with PathAI to leverage artificial intelligence in advancing pathology imaging, enhancing diagnostic accuracy for cancer patients. The collaboration will integrate PathAI’s algorithms into Roche’s NAVIFY Digital Pathology platform, enabling pathologists to access cutting-edge AI tools for improved treatment decisions. This agreement expands Roche’s Digital Pathology Open Environment, supporting the development of companion diagnostics and drug programs across multiple cancer types.