CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Roche teams up with PathAI, Ibex for AI-based digital path workflow
November 2021—Roche has entered into separate agreements with PathAI and Ibex Medical Analytics in which the companies will jointly develop embedded image analysis workflows for pathologists.
These collaborations are possible through Roche’s Digital Pathology Open Environment, which allows pathologists to access third-party AI-powered technology alongside Roche’s menu of AI-based image analysis tools.
In an Oct. 15 statement, Andy Beck, MD, PhD, PathAI CEO, said of the partnership with Roche: “This collaboration brings together all of the components required to deliver and commercialize a differentiated AI-based digital pathology medical device including assay, scanner, image management system, and algorithm.”
Ibex’s Galen platform received FDA breakthrough device designation and received the CE mark for breast and prostate cancer detection. Under its agreement with Roche, users of Roche’s Navify digital pathology software will be able to access Ibex’s AI algorithms and tools, including its algorithms that analyze prostate and breast biopsies.
Paige authorized to market Paige Prostate software
The FDA authorized in September the marketing of Paige Prostate to assist in detecting areas suspicious for cancer as an adjunct to the review of digitally scanned slide images from prostate biopsies.
The FDA evaluated data from a clinical study in which 16 pathologists examined 527 slide images of prostate biopsies (171 cancer, 356 benign) that were digitized using a scanner. For each slide image, each pathologist completed two assessments, one without Paige Prostate’s assistance and one with Paige Prostate’s assistance. While the clinical study did not evaluate the impact on final patient diagnosis, the study found that Paige Prostate improved detection of cancer on individual slide images by 7.3 percent on average when compared with unassisted reads for whole slide images of individual biopsies, with no impact on the read of benign slide images.
First hematology analyzer for malaria detection
Sysmex America introduced its XN-30 research use only automated hematology analyzer, the first for malaria detection. Specialized reagents, a violet laser, and advanced algorithms allow the XN-30 RUO to differentiate P. falciparum from non-falciparum species and determine the life cycle staging of the parasites detected.