NEW YORK ─ Digital pathology firm Indica Labs on Monday announced it has obtained CE marking for its Halo Prostate AI screening tool to help pathologists identify and grade prostate cancer in core needle biopsies.
The Albuquerque, New Mexico-based company said the screening tool operates alongside a pathologist to improve efficiency and add a layer of quality control to a diagnosis.
Halo Prostate AI is available through Indica Labs' CE-IVD marked Halo AP platform, which provides an automated end-to-end workflow and can operate as a standalone case management system or integrate with current laboratory information management systems (LIS).
The screening tool is scanner agnostic and was trained using digital scans obtained from multiple scanning platforms. It has been clinically validated against the Hamamatsu NanoZoomer S360 and Leica GT450 platforms, Indica Labs said.
The company added that it developed Halo Prostate AI in collaboration with the University of Cologne. Developers trained the screening tool using more than 870,000 training patches obtained from the annotation of digital scans that represent the full spectrum of prostate cancer subtypes and Gleason grades, as well as benign tissue, Indica Labs said.
In validation studies performed on 4,973 core needle biopsies from three independent cohorts in Austrian and German hospitals, the tool's algorithm demonstrated a level of sensitivity from 95 percent to 100 percent, specificity from 88 percent to 98 percent, and negative predictive value from 98 percent to 100 percent, Indica Labs said.
In the validation study, the algorithm correctly detected tumors in 26 cores that were originally reported as tumor negative, the company said.