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EXINI news

2 August, 2021

EXINI received FDA clearance for aPROMISE in the United States

On July 27th, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE™. aPROMISE was developed to quantify and standardize assessments of PSMA PET/CT images and will support the use of PYLARIFY® (piflufolastat F 18) in the U.S. aPROMISE is a convenient software platform that offers quantitative analysis and standardized reporting of PSMA PET/CT image assessments.

“With FDA clearance of aPROMISE, EXINI continues on the path to improve clinical management of prostate cancer patients with innovative and clinically relevant imaging biomarkers.” Aseem Anand, Vice President and Site Manager of EXINI Diagnostics AB, Sweden.
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15 April, 2021

aBSI is now available in United Kingdom

The EXINI devices, aBSI and EXINI bone, are now available in the United Kingdom again. EXINI Diagnostics has performed the necessary actions to be able to provide the devices to the UK customers after Brexit. QAdvis UK Ltd has been appointed as responsible person (UKRP) in the UK. Thereby we are able to continue to provide our innovative CE marked devices aBSI and EXINI bone to our UK customers.
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12 March, 2021

EXINI Diagnostics AB has achieved MDR-certification

The new European Medical Device Regulation 2017/745 (MDR) which replaces the Medical Devices Directive (93/42/EEC) will be mandatory from May 25th 2021. EXINI Diagnostics has through hard work and dedication received our MDR-certificate through our Notified Body TÜV SÜD.


“We are proud to be certified for MDR and look forward to enhancing the care of cancer patients with digital AI-solutions”
Dr. Aseem Anand. Vice President EXINI Diagnostics AB.

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16 November, 2020

EXINI’s Artificial Intelligence enabled product received FDA clearance on GE Healthcare’s XELERIS platform

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the use of EXINI’s artificial intelligence enabled automated bone scan index (aBSI) on GE Healthcare’s Xeleris platform. EXINI has entered into a global software licensing agreement with GE Healthcare for the rights to EXINI bone, a vendor neutral stand-alone variant of aBSI that is enabled with artificial intelligence. Under the terms of the non-exclusive agreement EXINI will receive tiered licensing fees per license sold. 

Automated Bone Scan Index (aBSI) 

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. 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, Switzerland, and UK. 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. 

EXINI Diagnostics AB 

EXINI Diagnostics AB was established in 1999 to commercialize AI methods for automated analysis of diagnostic images developed by a research group at Lund University. As a certified medical device manufacturer, EXINI has developed automated analysis platforms for cardiac, brain and bone scans. The company has always been innovative, developing web-based systems in the early 2000s. EXINIs most widely distributed platform is used to calculate the automated Bone Scan Index, which quantifies the bone tumor burden in patients with metastatic prostate cancer. This platform has been installed at about 1,000 hospitals worldwide. In 2015, EXINI was acquired by Progenics Pharmaceuticals Inc. for developing patient centric AI technologies for PSMA-targeted theranostic agents. In 2020, Progenics Pharmaceuticals, Inc. was acquired by Lantheus Holdings, Inc.

 

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22 June, 2020

Lantheus Completes Merger with Progenics

Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. (“LMI”), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, today announced that it has completed its previously announced merger with Progenics Pharmaceuticals, Inc. (“Progenics”) (Nasdaq: PGNX), an oncology company developing innovative medicines and artificial intelligence to find, fight and follow cancer. The merger agreement was first announced on October 2, 2019.

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28 August, 2019

EXINI receives FDA clearance for aBSI in United States

In August, EXINI received 510(k) clearance from the FDA to market aBSI for clinical use in the U.S. The clearance of a cloud based software as a medical device is an essential step towards the further development and clearance of the PSMA(PyL) AI product. In October, we were able to release aBSI 3.5.0 as the first FDA cleared aBSI version.

“The FDA clearance is a validation of our approach in using AI technology to solve clinically relevant problems in disease management of patients with prostate cancer” said Aseem Anand, Vice President and Site Manager of EXINI Diagnostics AB, Sweden.

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25 July, 2019

Collaboration with Veterans Affairs in United States on the AI Research Program for Medical Image Analysis

On July 25, 2019, EXINI a fully owned subsidiary of Progenics Pharmaceuticals, entered into collaboration with the Veterans Affairs Greater Los Angeles Healthcare System (VAGLAHS), United States, on its AI research program. The collaborative program aims to apply machine learning to medical imaging modalities, enabling standardized, information-driven healthcare practices in prostate cancer. The project is the nation’s first collaborative effort to validate cutting-edge machine learning tools for improving treatment management of Veterans with prostate cancer.

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24 June, 2019

EXINI PSMA-AI device highlighted at SNMMI 2019

June 24, at Anaheim, CA – EXINI team presented the performance of PSMA-AI device in an independent and prospectively defined study. The work was selected for an Oral presentation at SNMMI2019 and was picked for discussion in the highlight summary session. 

In a prospectively defined independent study, the data demonstrated that the AI-device assisted reads were better than manual only read in terms of speed, precision and diagnostic accuracy. The data is part of continual effort to enhance the clinical utility of imaging biomarkers with standardized and accurate assessment. 

Our focus remains on using technology to address clinically relevant questions for treatment management of Prostate Cancer. 

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18 June, 2019

EXINI Agreement with FUJIFILM Toyama Chemical Co. in Japan

As of June 18, 2019, EXINI, a wholly owned subsidiary of Progenics Pharmaceuticals Inc. has entered into a licence and transfer agreement with FUJIFILM Toyama Chemical Co, Ltd. (FFTC) for the rights to Automated Bone Scan Index (aBSI) product in Japan for use under the name BONENAVI.

aBSI has become an integral component of prostate cancer practice patterns in Japan, and we are delighted to continue our relationship with FFTC, a leading Japanese pharmaceutical and diagnostic company, to offer this optimized and quick response technology solution to support physician treatment decisions for prostate cancer patients.

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aBSI and EXINI bone

A software as a medical device manufactured by EXINI Diagnostics AB.

Performance Characteristics

In non-clinical and clinical investigations, aBSI/EXINI bone has demonstrated safety and effectiveness in analyzing and quantifying nuclear medicine bone scan in oncology. In a set of analytical validation studies demonstrated the following: Linearity of the automated BSI interpretations in the range of 0.10–13.0 was confirmed, and Pearson correlation was observed at 0.995 (n=50; 95% confidence interval, 0.99–0.99; P<0.0001). The mean coefficient of variation was less than 20%. The mean BSI difference between the 2 repeat bone scans of 35 patients was 0.05 (SD=0.15), with an upper confidence limit of 0.30. The interobserver agreement in the automated BSI interpretations was more consistent (κ=0.96, P<0.0001) than the qualitative visual assessment of the changes (κ=0.70, P<0.0001) was in the bone scans of 173 patients. In a large prospectively phase III clinical study, investigators demonstrated that in a multivariable survival model, aBSI/EXINI bone remained independently associated with OS (HR, 1.06; 95% CI, 1.01- 1.11; P=0.03).

Warnings

Always ensure that the patient name, patient ID and study date displayed in the patient section correspondto the patient case you intend to review.

The quantification results including the automated BSI must not be used as a tool for diagnostic or treatment decisions. They are intended to be used as a guide in the visual interpretation of bone scans. You must not rely solely on the quantification results of the software but use additional data points to determine a diagnosis and necessary treatment.

Always review the images and quantification results in the BSI report to ensure that the information exported is correct.

Ydelsesspecifikationer

I ikke-kliniske og kliniske undersøgelser har aBSI/EXINI bone vist sig at kunne analysere og kvantificere nuklearmedicinsk knoglescanning inden for onkologi på en sikkert og effektiv måde. En række analytiske valideringsundersøgelser viste følgende: Lineariteten af de automatiserede BSI-fortolkninger i intervallet 0,10-13,0 blev bekræftet, og Pearson-korrelationen blev observeret ved 0,995 (n=50; 95% konfidensinterval, 0,99-0,99; P<0,0001). Den gennemsnitlige variationskoefficient var mindre end 20 %. Den gennemsnitlige BSI-forskel mellem to gentagne knoglescanninger af 35 patienter var 0,05 (SD=0,15) med en øvre konfidensgrænse på 0,30. Interobserveroverensstemmelsen i de automatiserede BSI-fortolkninger var mere konsistente (κ= 0,96, P<0,0001), end den kvalitative visuelle vurdering af ændringerne (κ= 0,70, P=0,0001) var i knoglescanninger af 173 patienter. I en stor prospektiv fase III klinisk undersøgels påviste forskerne, at i en multivariabel overlevelsesmodel forblev aBSI/EXINI bone uafhængigt forbundet med OS (HR, 1,06; 95% CI, 1,01-1,11; P = 0,03).

Advarsler

Det skal altid sikres, at patientens navn, patient-ID og studiets dato, der vises i patientafsnittet, svarer til den patient, der skal gennemgås.

Kvantificeringsresultaterne, herunder den automatiske BSI-værdi, må ikke anvendes til diagnostiske eller behandlingsmæssige beslutninger. Disse resultater er beregnet til at blive brugt vejledende ved den visuelle fortolkning af knoglescanninger. Undlad udelukkende at stole på kvantificeringsresultaterne fra softwaren, men brug yderligere datapunkter til at finde frem til en diagnose og den tilhørende behandling.

Gennemgå altid billederne og kvantificeringsresultaterne i BSI-rapporten for at sikre, at de eksporterede oplysninger er korrekte.

Leistungsmerkmale

aBSI/EXINI bone hat in nicht-klinischen und klinischen Studien Sicherheit und Wirksamkeit bei der Analyse und Quantifizierung des nuklearmedizinischen Knochenscans in der Onkologie gezeigt. In einer Reihe von analytischen Validierungsstudien wurde Folgendes nachgewiesen: Die Linearität der automatisierten BSI-Interpretationen im Bereich von 0,10–13,0 wurde bestätigt, und die Pearson-Korrelation wurde bei 0,995 beobachtet (n=50; 95% Konfidenzintervall, 0,99–0,99; P<0,0001). Der mittlere Variationskoeffizient lag unter 20 %. Die mittlere BSI-Differenz zwischen den 2 wiederholten Knochenscans von 35 Patienten betrug 0,05 (SD=0,15) mit einer oberen Konfidenzgrenze von 0,30. Die Interobserver-Übereinstimmung in den automatisierten BSIInterpretationen war konsistenter (κ=0,96, P<0,0001) als die qualitative visuelle Beurteilung der Veränderungen (κ=0,70, P<0.0001) bei den Knochenscans von 173 Patienten. In einer großen prospektiven klinischen Phase-III-Studie zeigten die Forscher, dass aBSI/EXINI bone in einem multivariablen Überlebensmodell unabhängig mit OS assoziiert blieb (HR 1,06; 95% CI, 1,01-1,11; P=0,03).

Warnungen

Vergewissern Sie sich immer, dass der Patientenname, die Patienten-ID und das Studiendatum, die im Patientenbereich angezeigt werden, mit dem Patientenfall, den Sie prüfen möchten, übereinstimmen.

Die Quantifizierungsergebnisse einschließlich des automatisierten BSI dürfen nicht als Grundlage für Diagnose- oder Behandlungsentscheidungen herangezogen werden. Sie sollen als Richtlinie für die visuelle Interpretation von Knochenscans dienen. Stützen Sie sich nicht ausschließlich auf die Quantifizierungsergebnisse der Software, sondern verwenden Sie zusätzliche Datenpunkte, um eine Diagnose zu erstellen und die erforderliche Behandlung festzulegen.

Prüfen Sie immer die Bilder und Quantifizierungsergebnisse im BSI-Bericht, um sicherzustellen, dass die exportierten Informationen korrekt sind.

Características de rendimiento

En investigaciones no clínicas y clínicas, aBSI/EXINI bone ha demostrado seguridad y eficacia en el análisis y cuantificación de la gammagrafía ósea de medicina nuclear en oncología. En un conjunto de estudios de validación analítica demostró lo siguiente: Se confirmó la linealidad de las interpretaciones automatizadas del BSI en el rango de 0,10–13,0, y se observó la correlación de Pearson a 0,995 (n=50; 95 % intervalo de confianza, 0,99–0,99; P<0,0001). El coeficiente de variación medio fue inferior al 20 %. La diferencia media del BSI entre las dos gammagrafías óseas repetidas de 35 pacientes fue de 0,05 (SD=0,15), con un límite de confianza superior de 0,30. La concordancia entre observadores en las interpretaciones automatizadas del BSI fue más coherente (κ=0,96, P<0,0001) que la evaluación visual cualitativa de los cambios (κ= 0,70, P<0,0001) se encontraba en las gammagrafías óseas de 173 pacientes. En un estudio clínico grande prospectivo en fase III, los investigadores demostraron que en un modelo de supervivencia multivariable, aBSI/EXINI bone permaneció asociado independientemente con OS (HR, 1,06; IC del 95 %, 1,01-1,11; P=0.03).

Advertencias

Asegúrese siempre de que el nombre del paciente, el identificador del paciente y la fecha del estudio que se muestran en la sección del paciente se correspondan con el caso del paciente que pretende revisar.

Los resultados de cuantificación, incluido el BSI automatizado, no deben utilizarse como herramienta para decisiones de diagnóstico o tratamiento. Están destinados a ser utilizados como una guía en la interpretación visual de las gammagrafías óseas. No debe basarse únicamente en los resultados de cuantificación del software, sino utilizar puntos de datos adicionales para determinar un diagnóstico y el tratamiento necesario.

Revise siempre las imágenes y los resultados de cuantificación en el informe del BSI para asegurarse de que la información exportada sea correcta.

Caractéristiques de performance

Dans le cadre d’études non cliniques et cliniques, aBSI/EXINI bone a démontré sa sécurité et son efficacité dans l’analyse et la quantification de la scintigraphie osseuse (médecine nucléaire) en oncologie. Un ensemble d’études de validation analytique a démontré les points suivants : la linéarité des interprétations automatisées du BSI dans la plage de 0,10-13,0 a été confirmée, et la corrélation de Pearson a été observée à 0,995 (n=50 ; intervalle de confiance à 95 %, 0,99-0,99 ; P<0,0001). Le coefficient de variation moyen était inférieur à 20 %. La différence de BSI moyenne entre les 2 scintigraphies osseuses consécutives chez 35 patients était de 0,05 (ET=0,15), avec une limite de confiance supérieure de 0,30. La concordance inter-observateur dans les interprétations automatisées du BSI était plus cohérente (κ=0,96, P<0,0001) que l’évaluation visuelle qualitative des variations (κ=0,70, P< 0,0001) dans les scintigraphies osseuses de 173 patients. Dans une vaste étude clinique prospective de phase III, les investigateurs ont démontré, dans un modèle de survie multivarié, que le aBSI/EXINI bone automatisé est resté indépendamment associé à la SG (HR, 1,06 ; IC à 95 %, 1,01-1,11 ; P = 0,03).

Mises en garde

Vérifiez toujours que le nom du patient, son identifiant et la date de l’étude indiqués dans la section du patient correspondent bien au cas du patient que vous souhaitez examiner.

Les résultats de quantification, y compris le BSI automatisé, ne doivent pas être utilisés pour la prise de décisions diagnostiques ou thérapeutiques. Ils sont prévus pour servir de guide dans l’interprétation visuelle des scintigraphies osseuses. Vous ne devez pas vous appuyer uniquement sur les résultats de quantification du logiciel, mais utiliser également des points de données supplémentaires afin de poser un diagnostic et de déterminer le traitement approprié.

Passez toujours en revue les images et les résultats de quantification dans le rapport de BSI pour vous assurer que les informations exportées sont correctes.

Prestatiekenmerken

In niet-klinische en klinische onderzoeken heeft aBSI/EXINI bone de veiligheid en effectiviteit aangetoond bij het analyseren en kwantificeren van botscans door nucleaire geneeskunde in de oncologie. In een reeks analytische valideringsstudies is het volgende aangetoond: De lineariteit van de geautomatiseerde BSI-interpretaties in het bereik van 0,10-13,0 werd bevestigd en Pearsoncorrelatie werd waargenomen op 0,995 (n=50; 95% betrouwbaarheidsinterval, 0,99-0,99; P<0,0001). De gemiddelde variatiecoëfficiënt was minder dan 20%. Het gemiddelde BSI-verschil tussen de 2 herhaalde botscans van 35 patiënten was 0,05 (SD=0,15), met een bovengrens van de betrouwbaarheid van 0,30. De interobserverovereenkomst in de geautomatiseerde BSI-interpretaties was consistenter (κ= 0,96, P<0,0001) dan de kwalitatieve visuele beoordeling van de veranderingen (κ=0,70, P<0,0001) in de botscans van 173 patiënten. In een grote prospectieve fase III klinische studie hebben onderzoekers aangetoond dat in een multivariabel survivalmodel, aBSI/EXINI bone onafhankelijk geassocieerd bleef met OS (HR, 1,06; 95% BI, 1,01-1,11; P = 0,03).

Waarschuwingen

Controleer altijd of de naam van de patiënt, patiënt-ID en onderzoeksdatum die in de patiëntensectie worden weergegeven, overeenkomen met het patiëntendossier dat u gaat bekijken.

De gekwantificeerde resultaten inclusief de automatische BSI mogen niet worden gebruikt als hulpmiddel voor diagnostiek of bij behandelbeslissingen. Ze zijn bedoeld als handleiding voor de visuele interpretatie van botscans. U mag niet uitsluitend vertrouwen op de gekwantificeerde resultaten van de software, maar u dient extra gegevenspunten te gebruiken om een diagnose te stellen en een noodzakelijke behandeling te bepalen.

Bestudeer altijd de beelden en kwantificeringsresultaten in het BSI-rapport om te zorgen dat de informatie die wordt geëxporteerd correct is.

Ytelsesegenskaper

I ikke-kliniske og kliniske undersøkelser har aBSI/EXINI bone vist seg å være sikker og effektiv ved analysering og kvantifisering av nukleærmedisinsk skjelettscintigrafi for onkologi. Analytiske valideringsstudier viste følgende: Lineariteten til de automatiserte BSItolkningene i området 0,10–13,0 ble bekreftet, og Pearson korrelasjonskoeffesient var 0,995 (n=50; 95 % konfidensintervall, 0,99–0,99; P<0,0001). Gjennomsnittlig variasjonskoeffisient var mindre enn 20 %. Gjennomsnittlig BSI-forskjell mellom de to gjentatte skjelettscintigrafiene av 35 pasienter var 0,05 (SD=0,15), med en øvre konfidensgrense på 0,30. Overensstemmelse mellom observatører for de automatiserte BSI-tolkningene var bedre (κ=0,96, P<0,0001) enn for den kvalitative visuelle vurderingen av endringene (κ=0,70, P<0,0001) i skjelettscintigrafier av 173 pasienter. I en stor klinisk prospektiv fase III-studie viste utprøvere at aBSI/EXINI bone forble uavhengig assosiert med OS i en multivariabel overlevelsesmodell (HR, 1,06; 95 % KI, 1,01–1,11; P=0,03).

Advarsler

Sørg alltid for at pasientnavn, pasient-ID og studiedatoen som vises i pasientdelen, stemmer med det pasienttilfellet du skal granske.

Kvantifiseringsresultatene, som omfatter den automatiserte BSI (Bone Scan Index), må ikke brukes som et verktøy for beslutninger om diagnose eller behandling. De er ment å brukes som veiledning ved visuell tolkning av skjelettscintigrafier. Du må ikke stole utelukkende på programvarens kvantifiseringsresultat, men benytte ytterligere datapunkter for å faststille en diagnose og nødvendig behandling.

Du må alltid granske bildene og kvantifiseringsresultatene i BSI-rapporten for å sikre at den eksporterte informasjonen er korrekt.

Prestandaegenskaper

I icke-kliniska och kliniska undersökningar har aBSI/EXINI bone visat säkerhet och effektivitet i att analysera och kvantifiera nukleärmedicinska skelettscintigrafier inom onkologi. I en uppsättning analytiska valideringsstudier visades följande:
Linjäriteten hos de automatiserade BSI-tolkningarna i intervallet 0,10–13,0 bekräftades, och Pearson-korrelationen observerades vid 0,995 (n=50; 95 % konfidensintervall, 0,99–0,99; P<0,0001). Den genomsnittliga variationskoefficienten var mindre än 20 %. Den genomsnittliga BSI-skillnaden mellan 2 upprepade skelettscintigrafier av 35 patienter var 0,05 (SD=0,15), med ett övre konfidensintervall på 0,30. Interobserveravtalet i de automatiserade BSI-tolkningarna var mer konsekventa (κ=0,96, P<0,0001) än vad den kvalitativa visuella bedömningen av förändringarna (κ=0,70, P<0,0001) var i skelettscintigrafierna av 173 patienter. I en stor prospektiv klinisk fas III-studie, har utredarna visat att aBSI/EXINI bone, i en multivariabel överlevnadsmodell, förblev oberoende relaterad till OS (HR, 1,06; 95 % CI, 1,01-1,11; P = 0,03).

Varningar

Säkerställ alltid att patientnamn, patient-ID och studiedatum som visas i patientdelen verkligen stämmer med det patientfall du ska granska.

Kvantifieringsresultaten, som innefattar den automatiserade BSI (Bone Scan Index), får inte användas som ett verktyg för beslut om diagnos eller behandling. De är avsedda att användas som vägledning vid visuell tolkning av skelettscintigrafier. Du får inte lita enbart till programvarans kvantifieringsresultat, utan måste använda ytterligare datapunkter för att fastställa en diagnos och nödvändig behandling.

Granska alltid bilderna och kvantifieringsresultaten i BSI-rapporten för att säkerställa att den exporterade informationen är korrekt.