Article

Digital pathology image analysis algorithms

Confidence starts with clarity

Harness the power of artificial intelligence to remove time-consuming quantification and qualification tasks from your pathology workflow, allowing you to focus on more meaningful tasks.

The uPath image analysis algorithms for pathology decision support extract meaningful information from pathology slide images so that pathologists can quickly, accurately and confidently assess immunohistochemistry and in-situ hybridization. Algorithms in the uPath image analysis algorithm suite provide image analysis of VENTANA slide scanner images stained with a Roche Tissue Diagnostics assay.

In 2011, Roche was the first company to receive 510(k) clearance from the U.S. Food and Drug Administration (FDA) on our first generation image analysis algorithms (i.e., VENTANA Companion Algorithm HER2 (4B5))1. At the time, Roche was the only company in the industry offering a comprehensive portfolio of FDA-cleared image analysis algorithms and digital read applications for the five key immunohistochemistry (IHC) breast markers.2 Since then, the technology has evolved and we have launched whole slide analysis image analysis algorithms including uPath HER2 (4B5) image analysis, Breast3, uPath HER2 Dual ISH image analysis, Breast3, uPath PD-L1 (SP263) image analysis, NSCLC3,  uPath ER (SP1) image analysis, Breast4, uPath PR (1E2) image analysis, breast4 and uPath Ki-67 (30-9) mage analysis, breast.4

Roche is invested in aiding the pathologist and will continue to deliver next-generation image analysis algorithms that provide pathologists with more tools to improve efficiency and precision.

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Efficient slide evaluation

“A positive resection margin of a melanoma in situ which had been initially missed using remote-controlled microscopy was identified using WSI”.

Dr. Belen Lloveras,

Chief of the Pathology Department

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Enhancing precision medicine

“Precision medicine isn’t just about giving a drug to a particular patient; it’s about giving a specific diagnosis to that patient so they can get specific treatment. Roche Digital Pathology helps us to give precision diagnoses.”

Dra. Ma Dolores Lozano Escario, 

Joint Director of the Anatomic Pathology Department

Clínica Universidad de Navarra

Connect with a Roche representative

Find out how you can enhance digital pathology in your laboratory with best-in-class image analysis algorithms for advanced digital pathology.

References

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111543; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121516; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K130515 ;  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111755 ; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K121033;  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111872 ;  https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K142965 ; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K122143 ; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K111869 ; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140465
  2. https://www.prnewswire.com/news-releases/ventana-receives-fda-clearance-for-estrogen-receptor-er-image-analysis-and-digital-read-application-for-breast-cancer-234579611.html
  3. CE-IVD marked. For Research Use Only in the US.
  4. For Research Use Only. Not for use in diagnostic procedures.

Regulatory statement:

IVD products can be used for in-vitro diagnostic use. RUO products are for research use only and not for diagnostic procedures. Refer to the product-specific labeling for the regulatory status of image analysis algorithms.

 

VENTANA, COMPANION ALGORITHM and UPATH are trademarks of Roche. Other product names and trademarks are the property of their respective owners.