The automated Bone Scan Index (aBSI) technology, developed by EXINI Diagnostics AB, gives a fully quantitative assessment of bone scans that incorporates inferred masses of all lesions. The computed index reflects the proportion of the total skeleton mass that is observed to have tumor involvement1. In a prospectively defined multi-institutional phase 3 study with 721 metastatic prostate cancer patients, aBSI was found to be an independent prognostic determinant of overall survival and the study supported using aBSI in the design and eligibility for clinical trials for systemic therapies for metastatic castration-resistant prostate cancer2.
As of 2017, aBSI is provided as a secure and compliant web application readily available from a web browser by logging in to www.bonescanindex.com. In Europe, the device is CE-marked according to MDD 93/42 EEC, and is available for clinical use in Austria, Denmark, France, Germany, Ireland, Netherlands, Sweden, and Switzerland. As of October 2019, aBSI is also available for clinical use in the United States with a 510(k) clearance (K191262).
aBSI is also available for local installation under the name EXINI bone. As of January 2019, EXINI bone is CE marked according to MDD 93/42 EEC.
- Ulmert D, et al. A novel automated platform for quantifying the extent of skeletal tumour involvement in prostate cancer patients using the Bone Scan Index. Eur Urol. 2012.
- Armstrong AJ et al. Phase 3 Assessment of the Automated Bone Scan Index as a Prognostic Imaging Biomarker of Overall Survival in Men With Metastatic Castration-Resistant Prostate Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018.
When you use aBSI 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 aBSI, are the data controller and EXINI, as the service provider, is the data processor. In advance of processing data with aBSI, be sure that you have explicit consent from the patient whose data you are capturing. When data is sent to aBSI, 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 – where 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 – where we use a third-party to process personal information on your behalf we have data processor agreements and/or business associate agreements in place
BONENAVI, the platform to calculate bone scan index in Japan, was launched 2011 with partner FUJIFILM RI Pharma. The platform is developed and validated for Japanese patient population. Since its launch in 2011, nearly 900 hospitals have incorporated BONENAVI in their regular clinical workflow. Illustrative BONENAVI reports are used in discussing treatment evaluation with patients. The society of nuclear medicine in Japan recommends bone scan index for use in metastatic prostate cancer to assess metastatic burden in bone. The availability of BONENAVI has generated clinical value of the bone scan in prostate cancer.
In June 2019, FUJIFILM bought the exclusive rights of BONENAVI in Japan.