EXINI Diagnostics Receives CE Mark Clearance for aPROMISE

EXINI Diagnostics AB, a subsidiary of Lantheus Holdings Inc., a fully integrated provider of innovative imaging diagnostics, targeted therapeutics and artificial intelligence (AI) solutions for serious medical conditions, has received CE Mark clearance for aPROMISE in Europe.
 
aPROMISE is artificial intelligence-based, deep learning-enabled, medical device software that allows healthcare professionals and researchers to perform quantitative assessment of prostate-specific membrane antigen (PSMA) PET/CT in oncology. aPROMISE includes a solution for automated body segmentation and marking, quantifying and reporting suspicious lesions in their anatomical context.^1,2 The AI tool provides enhanced consistency in quantitative analysis and is intended to increase efficiency, accuracy and reproducibility of PSMA PET/CT image assessments.

“The aPROMISE CE Mark clearance is an exciting milestone for Lantheus on the path to possible U.S. approval later this year,” said Etienne Montagut, senior vice president, Corporate Development. “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.”
 
In a prospectively planned independent analysis of the PyL OSPREY trial, aPROMISE demonstrated a high reproducibility with an intraclass correlation coefficient (ICC) of 0.99 (95 percent CI 0.99 – 0.99). In metastatic prostate cancer patients, the sensitivity of aPROMISE in a pre-selection of lesions was 92 percent for regional lymph nodes, 91 percent for distant lymph nodes, and 87 percent for bone.
 
“The Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE) criteria has proposed a uniform language for objective reporting to assist physicians in assessing a patient’s tumor burden and also provides clinically meaningful information to physicians for developing therapeutic plans,” said Matthias Eiber, of the Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University of Munich, Munich, Germany. “With the introduction of automation to the PROMISE criteria, the software is able to facilitate adherence to standardized reporting in clinical practice by reducing reporting time and limitations of manual assessment.”
 
PyL (also known as 18F-DCFPyL) is an investigational fluorinated PSMA-targeted PET imaging agent that enables visualization of localized prostate cancer both localized as well as metastatic to lymph nodes, bone and soft tissue to detect and localize recurrent and/or metastatic prostate cancer. 
 
The OSPREY trial was designed to assess the diagnostic performance of PyL to detect prostate cancer in pelvic lymph nodes in subjects with high-risk prostate cancer (Cohort A) and confirm distant metastases in subjects with metastatic or recurrent prostate cancer (Cohort B). The primary endpoints for the trial were sensitivity and specificity of PyL PET/CT imaging to detect metastatic prostate cancer within the pelvic lymph nodes relative to histopathology in Cohort A. A key secondary endpoint of the trial was the sensitivity of PyL PET/CT imaging to detect prostate cancer within sites of metastasis or local recurrence relative to histopathology in Cohort B.
 
In the trial, the diagnostic performance of PyL in detecting disease in pelvic lymph nodes (Cohort A) was compared with histopathology. PyL showed specificity of 96-99 percent, sensitivity of 31-42 percent, and PPV of 78-91 percent meeting the specificity but not the pre-established sensitivity co-primary endpoint. In the metastatic or recurrent prostate cancer setting (Cohort B), PyL exhibited sensitivity of 93-99 percent and PPV of 81-88 percent in detecting metastatic lesions. Overall, PyL demonstrated high diagnostic performance in reliably detecting nodal and distant metastatic prostate cancer.
 
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging Inc., Progenics Pharmaceuticals Inc., and EXINI Diagnostics AB. The company is headquartered in North Billerica, Mass., with offices in New York, New Jersey, Canada, and Sweden. 

References 
¹ Deep Learning-Enabled Comprehensive Detection and Quantification of 18FDCFPyL (PyL-PSMA) PET/CT. Brynolfsson J, Johnsson K, Sahlstedt H, Richter J, et al, OP-548, 1006: Cutting Edge Science Track – TROP Session: AI -Radiomics and Modelling, EANM 2020.
² miPSMA Index: Comprehensive and Automated Quantification of 18F-DCFPyL (PyL-PSMA) PET/CT for Prostate Cancer Staging. Johnsson K, Sahlstedt H, Brynolfsson J, et al. J Nucl Med. 2020;61(1):1435