In the Pan-European multicenter clinical study FirstPath, INIFY Prostate produced highly accurate, robust and homogenous results at all sites

STOCKHOLM – August 31, 2021 – ContextVision, a medical technology software company specializing in image processing, image analysis and decision support tools for digital pathology, today announced that results from FirstPath – a European multicenter clinical study evaluating performance of INIFY^® Prostate in routine clinical practice – were presented at the European Congress of Pathology by Dr. Jordi Temprana Salvador from Vall d’Hebron in Barcelona.

The study was performed at four sites: Cannizzaro Hospital, Catania, Italy; Linköping University Hospital, Linköping, Sweden; Hospital Bicêtre, Paris, France; and Vall d’Hebron, Barcelona, Spain. Dr Jordi Temprana Salvador presented the combined results from all sites. Prostate biopsies from all sites were reviewed with and without INIFY by two pathologists at each site. In total, over 300 biopsy images from 48 patients were reviewed.

“The study showed that the INIFY Product is robust across sites, tissue preparation, scanning and pathologists, and all pathologists in the study had a positive impression of INIFY’s performance,” says Dr Temprana Salvador.

The objective of the study was to evaluate the robustness of INIFY Prostate’s performance across different labs. In addition, INIFY Prostate’s usability was tested.

In the study, a high sensitivity of 98% and a high specificity of 96% for correct cancer diagnosis were seen when INIFY was used.  A known challenge for AI-based tools is handling image variations caused by different tissue preparations and scanners. INIFY proved to handle these variations with excellence – results were robust and homogenous for all sites. Moreover, results indicate that INIFY support will keep different pathologists’ diagnoses more aligned.  
In the study, INIFY’s usability was highly ranked by all pathologists; they especially liked the intuitive, fast and user-friendly viewer.

INIFY is a powerful AI-based software that precisely outlines suspected cancerous areas in prostate biopsies, with unique, detailed pixel-level focus – a result of MasterAnnotation, a patented annotation method used in training of the algorithms. In INIFY all slides are pre-predicted and examination-ready when the case is opened. Those with the most suspicious areas are presented first, with an automatic calculation of the suspicious cancer area percentage in each slide.

“The results point towards our ambition to create real value for the pathologists, to make diagnosis more efficient, more accurate and less subjective. Also, they confirm INIFY’s robustness – a vital aspect for a product intended to be used worldwide,” says Magnus Aurell, VP Business Unit Digital Pathology at ContextVision.

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For further information, please contact ContextVision's CEO, Fredrik Palm, [email protected] or visit www.contextvision.com

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About ContextVision
ContextVision is a medical technology software company specialized in image analysis and artificial intelligence. As the global market leader within image enhancement, we are a trusted partner to leading manufacturers of ultrasound, X- ray and MRI equipment around the world.

Our expertise is to develop powerful software products, based on proprietary technology and artificial intelligence for image-based applications. Our cutting-edge technology helps clinicians accurately interpret medical images, a crucial foundation for better diagnosis and treatment.

ContextVision is now entering the fast-growing digital pathology market. We are re-investing significantly in our product portfolio of decision support tools, and we are dedicated to becoming a leading resource for pathologists to radically develop cancer diagnosis and improve patient care.

The company, established in 1983, is based in Sweden with local representation in the U.S., Japan, China and Korea. ContextVision is listed on the Oslo Stock Exchange under the ticker CONTX.

This information is subject to the disclosure requirements pursuant to Section 5-12 of the Norwegian Securities Trading Act.

Attachment

• ContextVision - INIFY Prostate clinical study results