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.
In as little as one minute, the company says, the XN-30 RUO can report the level of parasitemia in an EDTA sample with a sensitivity as low as 20 malaria-infected red blood cells per microliter.
“The XN-30 research use only automated hematology analyzer delivers workflow efficiency and enhanced staff productivity to research labs currently performing manual microscopy for detection of malaria or relying on rapid diagnostic tests to screen symptomatic patients,” Andy Hay, Sysmex America CEO, said in a statement. “Unlike current microscopy and PCR methods, minimal training is needed to use the XN-30 RUO.”
Using fluorescent stains and flow cell technology, the XN-30 RUO standardizes detection and enumeration of intracellular malarial parasites. Three levels of quality control material ensure analyzer performance.
ABPath Continuing Certification changes for ’22
The American Board of Pathology is making changes to its Continuing Certification (CC) program beginning in January 2022.
The CC program has two main requirements for maintaining certification: quarterly participation in ABPath CertLink and submission of biennial reporting forms.
Here are the changes to come:
- All diplomates enrolled in the CC program must participate in ABPath CertLink. This will be the only option for meeting the CC assessment requirement for maintaining certification. CertLink is the online longitudinal assessment to facilitate learning and identify knowledge gaps that was previously a pilot program.
- ABPath will no longer administer a 10-year Continuing Certification exam.
- The expected performance standard for CertLink will be 60 percent correct or greater, cumulative over four years.
- Two quality assurance activities are required during a two-year reporting period instead of one per year.
- The annual $150 CC program fee will be due by Dec. 31 of each year.