Indica Labs Receives CE-IVD Mark For AI-Based Prostate Cancer Detection

"This has been a hugely positive collaboration with pathologists from around the world. We set out to build a clinical-grade algorithm that could improve turn-around time and diagnostic accuracy for prostate cancer patients, and I believe that is exactly what we have achieved. We are thrilled to see the first of many AI algorithms from Indica Labs attain CE-IVD marking."

Dr. Peter Caie, Principal Scientist of AI Collaboration, Indica Labs

This week Indica Labs announced CE-IVD Mark certification for HALO Prostate AI. This deep learning-based screening tool assists pathologists in identifying and grading prostate cancer in core needle biopsies. Developed in collaboration with Dr. Yuri Tolkach and colleagues?from the Institute of Pathology of the University of Cologne, the platform provides a fully validated and automated end-to-end workflow in tissue-based research, clinical trials, and diagnostics. Halo Prostate AI was trained using digital scans obtained from multiple scanning platforms and was designed to be scanner agnostic.

Indica Labs is based in Albuquerque New Mexico in close proximity to Los Alamos National Labs, Sandia National Laboratories, the University of New Mexico, New Mexico Tech and the Santa Fe Institute. The company was founded by experts in AI, image analysis, databases, network architecture and security from leading academic and pharmaceutical research organizations worldwide. Team members have deep expertise in pathology, oncology, neuroscience, metabolism, bioinformatics and computational science. Customers include Janssen, Merck, AstraZeneca, Novartis, Sanofi, Takeda, Pfizer, Regeneron, CDC, NIH, Columbia University, University of Pennsylvania, Cornell University, Brown University, Lund University, Fred Hutch, Genzyme, CDC, NIH, National Cancer Institute.

Image Source Indica Labs

“I am very excited about the digital future of pathology. With tools such as HALO Prostate AI, our work can be substantially optimized while controlling for high-quality, reliable, and objective diagnostics. HALO Prostate AI showed very high accuracy in the large multi-institutional study for tumor detection and Gleason Grading in prostate biopsies. It’s really enjoyable to work back-to-back with such a powerful AI assistant”.

Dr. Yuri Tolkach, Institute of Pathology, University of Cologne

Prostate cancer is the most common cancer diagnosed in men. There were over 1.4 million cases reported worldwide in 2020. Each prostate case includes multiple biopsy core whole slide images, which must be assessed by a pathologist for the presence of tumor and, if present, a Gleason score is reported. This represents a large workload for pathologists who screen multiple cases daily. HALO Prostate AI is designed to work alongside the pathologist to improve efficiency and to add a layer of quality control to ensure diagnostic accuracy.

Study Highlights

• HALO Prostate?AI was?trained?using?over?870,000?training patches?obtained from?the?annotation of digital scans.
• HALO Prostate AI showed very high accuracy in the large multi-institutional study for tumor detection and Gleason Grading in prostate biopsies.
• validation studies were performed on?4,973 core needle biopsies from?3 independent cohorts?sourced from hospitals in?Austria and Germany.
• the algorithm?achieved?high?sensitivity?(95–?100%),
• the algorithm?achieved?high specificity?(88-98%)?
• the algorithm?achieved?negative predictive value?(98–?100%)?
• the algorithm?correctly detected?tumor?in?26 cores?within the validation study that were originally?reported as?tumor negative.?
• HALO Prostate AI was trained using digital scans obtained from multiple scanning platforms and was designed to be scanner agnostic.

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Copyright ? 2022 Margaretta Colangelo. All Rights Reserved.

This article was written by?Margaretta Colangelo.?Margaretta is a leading AI analyst who tracks significant milestones in AI in healthcare. She's consulting at AI healthcare companies and she writes about some of the companies she's consulting with. Margaretta serves on the advisory board of the AI Precision Health Institute at the University of Hawai?i?Cancer Center?@realmargaretta