Press Release : Roche launches two digital pathology image analysis algorithms for precision patient diagnosis in breast cancer

 
   -- uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis aid 
      pathologists in providing faster, more accurate patient diagnoses in 
      breast cancer 
 
   -- In combination with the VENTANA DP 200 slide scanner and Roche uPath 
      enterprise software, the new algorithms provide innovative digital 
      pathology solutions to advance personalised healthcare 
 
   -- Nearly 2.1 million new cases of breast cancer are diagnosed worldwide 
      each year. About 15 to 20 percent of women diagnosed with breast cancer 
      are HER2 positive 
 
 
   Basel, 11 January 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today 
announced the CE-IVD launch of its automated digital pathology 
algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image 
analysis for breast cancer to help determine the best treatment strategy 
for each patient. The image analysis algorithms use artificial 
intelligence to support pathologists in making faster, more accurate 
patient diagnoses in breast cancer. 
 
   A mutation in the HER2 gene, which occurs in as many as 20 percent of 
the 2.1 million cases of breast cancer diagnosed globally each year, is 
responsible for aggressive growth in some patients. Identifying this 
mutation is important in determining which patients may benefit from 
targeted treatment.(1,2) 
 
   "About 15 to 20 percent of women diagnosed with breast cancer are HER2 
positive, which makes fast and accurate diagnosis critical," said Thomas 
Schinecker, CEO Roche Diagnostics. "Roche is continuing to innovate in 
HER2 diagnostics by providing precise information through image analysis 
algorithms for pathology decision support." 
 
   uPath HER2 (4B5) image analysis for breast cancer helps pathologists to 
quickly determine whether tumors are positive for the HER2 biomarker, 
highlighting positively stained tumor cell membranes with a clear visual 
overlay for easy reference. uPath HER2 Dual ISH image analysis for 
breast cancer assists the pathologist in the determination of HER2 gene 
amplification. A heatmap is provided to guide pathologists to areas of 
interest where the algorithm can identify cells to inform the 
determination of a treatment strategy. 
 
   Validated on the VENTANA HER2 (4B5) assay and the VENTANA HER2 Dual ISH 
DNA Probe Cocktail, the algorithms are ready-to-use and integrated 
within the Roche uPath enterprise software. The uPath HER2 (4B5) image 
analysis and uPath HER2 Dual ISH image analysis algorithms for breast 
cancer expand Roche's digital pathology portfolio to empower precision 
diagnosis. Roche is continuing to innovate in HER2 diagnostics through 
image analysis algorithms that provide an actionable assessment of 
scanned slide images that are objective and reproducible. 
 
   About uPath image analysis algorithm suite 
 
   The uPath image analysis algorithm suite for pathology decision support 
offers ready-to-use image analysis tools, providing fast, consistent and 
automated analysis so that pathologists can quickly, accurately and 
confidently assess immunohistochemistry and in situ hybridization. All 
algorithms in the suite for uPath software will provide image analysis 
of VENTANA DP 200 scanned slide images stained with a Roche Tissue 
Diagnostics assay. Together, Roche is delivering a new foundation of its 
digital pathology solution which will enable the development of 
artificial intelligence-based image analysis algorithms that can provide 
pathologists more tools to improve efficiency and precision. 
 
   Roche is delivering the end-to-end digital pathology solution from 
tissue staining to producing high-quality digital images that can be 
reliably assessed using automated clinical image analysis algorithms. 
Roche minimizes the variables that can impact analysis, and it is this 
end-to-end development that produces the quality results customers can 
depend on for making clinical decisions. With the acceleration of 
immunotherapy and the development of more complex assays, Roche is 
moving these traditionally research-oriented tools into routine clinical 
practice. 
 
   About breast cancer 
 
   Breast cancer is the second most common cancer in the world, with an 
estimated 1.7 million new cancer cases diagnosed in 2012 (25% of all 
cancers). It is the most common cancer in women globally. Incidence 
rates vary nearly four-fold across the world regions, with rates ranging 
from 27 per 100,000 in Africa and Asia to 92 per 100,000 in North 
America.(1,2) 
 
 
 
   About Roche 
 
   Roche is a global pioneer in pharmaceuticals and diagnostics focused on 
advancing science to improve people's lives. The combined strengths of 
pharmaceuticals and diagnostics under one roof have made Roche the 
leader in personalised healthcare -- a strategy that aims to fit the 
right treatment to each patient in the best way possible. 
 
 
 
   Roche is the world's largest biotech company, with truly differentiated 
medicines in oncology, immunology, infectious diseases, ophthalmology 
and diseases of the central nervous system. Roche is also the world 
leader in in vitro diagnostics and tissue-based cancer diagnostics, and 
a frontrunner in diabetes management. 
 
 
 
   Founded in 1896, Roche continues to search for better ways to prevent, 
diagnose and treat diseases and make a sustainable contribution to 
society. The company also aims to improve patient access to medical 
innovations by working with all relevant stakeholders. More than thirty 
medicines developed by Roche are included in the World Health 
Organization Model Lists of Essential Medicines, among them life-saving 
antibiotics, antimalarials and cancer medicines. Moreover, for the 
twelfth consecutive year, Roche has been recognised as one of the most 
sustainable companies in the Pharmaceuticals Industry by the Dow Jones 
Sustainability Indices (DJSI). 
 
 
 
   The Roche Group, headquartered in Basel, Switzerland, is active in over 
100 countries and in 2019 employed about 98,000 people worldwide. In 
2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 
61.5 billion. Genentech, in the United States, is a wholly owned member 
of the Roche Group. Roche is the majority shareholder in Chugai 
Pharmaceutical, Japan. For more information, please visit 
https://www.globenewswire.com/Tracker?data=pU5Icz84a9rPN0ZVfugzoj_vzyS8AAOWkxwOzvl6pTq20q3qZruBBE-Df6BcFLsY5zO5S5P-CFm8AxtttYdWYw== 
www.roche.com. 
 
 
 
   VENTANA and UPATH are trademarks of Roche. Other product names and 
trademarks are the property of their respective owners. 
 
 
 
   References 
 
   [1] World Health Organization. GLOBOCAN 2018; All cancers fact sheet. 
[Interned; cited July 2020]. Available from: 
https://www.globenewswire.com/Tracker?data=imGlE782__2yuuwrTvuz8vyII8OsUhVOpLVphewNu-LjDVAaNEeO2j4V0S9wYpXjLaWYD9H60n9KTLy2dzoNxdYKqWFvAkq9AbayWV0zmIOaCcrXhHFnxsX_PEhQSzNfPuPYrM62tAaf3DWjH_2ZesBJXsNJtAlTrHlZMsGMpxociRjP2pvx09QRCArppmuCwcp_6iLhuMK84s-O6M1v3NZ52HDPA_EDUmIjPAiKR_nxAq5cnPsY0HkG1YMpYsMp 
https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf 
 
 
   [2] Wolff AC, et al. Recommendations for human epidermal growth factor 
receptor 2 testing in breast cancer: American Society of Clinical 
Oncology/College of American Pathologists clinical practice guideline 
update. J Clin Oncol. 2013;31(31):3997-4013. 
 
 
 
 
 
   Roche Group Media Relations 
 
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(END) Dow Jones Newswires

January 11, 2021 01:03 ET (06:03 GMT)