Lantheus Holdings subsidiary EXINI Diagnostics has secured CE mark approval for its artificial intelligence (AI) based and deep learning-enabled medical device software called aPROMISE.
The software helps healthcare professionals and researchers conduct quantitative assessment of prostate-specific membrane antigen (PSMA) PET/CT in oncology.
aPROMISE consists of a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context.
Designed to offer consistency in quantitative analysis, the AI tool is targeted at improving efficiency, accuracy and reproducibility of PSMA PET/CT image assessments.
aPROMISE showed a high reproducibility with an intraclass correlation coefficient (ICC) of 0.99 in a prospectively planned independent analysis of the PyL OSPREY trial, said the company.
The sensitivity of aPROMISE in a pre-selection of lesions was 92% for regional lymph nodes, 91% for distant lymph nodes, and 87% for bone in metastatic prostate cancer patients.
Lantheus Holdings corporate development senior vice president Etienne Montagut said: “The aPROMISE CE Mark clearance is an exciting milestone for Lantheus on the path to possible U.S. approval later this year.
“We believe aPROMISE is a unique offering that could complement and strengthen our PSMA assets portfolio by improving their value and ease of use while assisting treating clinicians in their patient management decisions.”
PyL, which is also called as18F-DCFPyL, is an investigational fluorinated PSMA-targeted PET imaging agent that facilitates visualisation of localised prostate cancer.
The OSPREY trial is conducted to evaluate the diagnostic performance of PyL to identify prostate cancer in pelvic lymph nodes in subjects with high-risk prostate cancer (Cohort A).
The study is also designed to confirm distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B).
