Lantheus Holdings subsidiary Exini Diagnostics has secured the CE Mark for aPromise, an artificial intelligence software that helps clinicians assess prostate-specific membrane antigen (PSMA) PET/CT exams.
The software includes automated body segmentation and marking tools, as well as the ability to quantify and report suspicious lesions in an anatomical context, the company said. In the study of F-18 DCFPyL PET/CT imaging in patients with prostate cancer (OSPREY) phase II/III trial, which evaluated the use of the imaging agent PyL (F-18 DCFPyL) with PET/CT, the software demonstrated an intraclass correlation coefficient of 0.99. In metastatic prostate cancer patients, its sensitivity was 92% for regional lymph nodes, 91% for distant lymph nodes, and 87% for bone.
Lantheus Holdings hopes aPromise will be cleared by the U.S. Food and Drug Administration later this year, it said.
