aPROMISE is a medical device software developed by EXINI Diagnostics AB. aPROMISE is a PACS platform that offers quantitative analysis and standardized reporting of PSMA PET/CT image assessments. The software has a solution for automated body segmentation and marking, quantifying and reporting of regions of interest (ROIs) considered as suspicious lesions. The automated segmentation of reference organs and detection of ROIs with high local intensity uptake, so called hotspots, provide enhanced consistency in quantitative analysis and intend to increase the accuracy and efficiency of PSMA PET/CT image assessments.
In prostate cancer, PET tracers targeting the Prostate-Specific Membrane Antigen (PSMA) have demonstrated high diagnostic accuracy for the detection of both regional and distant metastatic prostate cancer. The higher sensitivity and specificity of the PSMA PET in detecting metastatic prostate cancer, may have strong implications in management of patients.
As of November 2021, aPROMISE is provided as a secure and compliant web application available by logging in to apromise.psmaix.com or via a locally provided URL when installed on the hospital server. In Europe, the device is CE-marked according to the MDR 2017/745 and available for clinical use in Austria, Belgium, Denmark, Finland, France, Germany, Italy, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal, Spain and Sweden. aPROMISE is also available for clinical use in the United Kingdom and in the United States with a 510(k) clearance (K211655).
Through rigorous performance studies, the aPROMISE has demonstrated:
- Higher Inter-reader reproducibility in staging (κ >0.80) and quantification (ICC 0.99) of prostate cancer patients.(1) The Quantitative assessment was associated with PSA and Gleason Score.(1)
- Accurate Lesion segmentation and detection sensitivity (>90%) for PSMA lesions in regional and distant lymph nodes.(2)
- High Efficiency in creating quantitative structure reporting. Average 3-5 minutes for a comprehensive, quantitative report.(1)
- Nickols N, Anand A, Johnsson K, et al. PYLARIFY AI: A Novel Automated-PROMISE platform to Standardize Evaluation of Tumor Burden in (18)F-DCFPyL (PSMA) images of Veterans with Prostate Cancer. J Nucl Med. 2021.
- Johnsson K, Brynolfsson J, Sahlstedt H, et al. Analytical performance of PYLARIFY AI: automated anatomic contextualization, detection, and quantification of [(18)F]DCFPyL (PSMA) imaging for standardized reporting. Eur J Nucl Med Mol Imaging. 2021.
When you use aPROMISE to process patient information related to a patient who is a resident of the EU, you are responsible for ensuring that your organization complies with GDPR. In terms of GDPR you, as the user of aPROMISE, are the data controller and EXINI, as the service provider, is the data processor. In advance of processing data with aPROMISE, be sure that you have explicit consent from the patient whose data you are capturing. When data is sent to aPROMISE, it is stored in a secure manner, and is encrypted in transit and at rest.
EXINI (‘we’ or ‘us’ or ‘our’) are committed and dedicated to ensuring the security and protection of the personal information that we process, and to provide a robust, continuous and consistent approach to data protection. Our objectives for GDPR and HIPAA compliance include the development and implementation of data protection roles, policies, procedures, controls and measures to ensure continuous safeguarding of the personal information under our remit.
How we are implementing GDPR and HIPAA
- Policies & Procedures – Data protection policies and procedures to meet the requirements and standards of the GDPR and any relevant data protection laws, including HIPAA, are in place
- Data Retention & Erasure – we have retention policies and are applying the privacy by design principle, meaning we store only data that is needed for the current task and only store it for as long as needed
- Data Breaches – as a medical device manufacturer we have breach procedures in place that ensure safeguards and measures to identify, assess, investigate and report any personal data breach at the earliest possible time
- International Data Transfers & Third-Party Disclosures – when EXINI stores or transfers personal information outside the EU, we have robust procedures and safeguarding measures in place to secure, encrypt and maintain the integrity of the data
- Processor Agreements – when we use a third-party to process personal information on your behalf, we have data processor agreements and/or business associate agreements in place