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Transmural Biotech completa la convalida europea di quantusMM, un test basato sull'intelligenza artificiale per la diagnosi del tumore al seno
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Transmural Biotech

Nov 10, 2022, 13:59 ET

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  • L'azienda di biotecnologie del gruppo ASISA ha sviluppato uno strumento non invasivo con una precisione del 92% nella diagnosi delle patologie mammarie. 

MADRID, 10 novembre 2022 /PRNewswire/ -- Transmural Biotech, l'azienda di biotecnologie del gruppo ASISA, ha completato il processo istituito dalle normative europee per la commercializzazione di quantusMM, un test non invasivo basato sull'intelligenza artificiale (IA), che consente la diagnosi delle patologie mammarie, compreso il tumore al seno, con una precisione del 92%, utilizzando le immagini acquisite dalle scansioni mammarie.

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Image of quantusMM análisis
Image of quantusMM análisis

Ottenere il marchio CE è un passo fondamentale nello sviluppo di questa tecnologia, in quanto tale marchio è valido anche per la maggior parte dei Paesi dell'Asia e dell'America latina. Nel caso del Brasile, Transmural ha già completato le procedure dell'Agência Nacional de Vigilância Sanitária (Anvisa) ed è in attesa di una convalida definitiva per la vendita del test sul mercato brasiliano.

quantusMM è un test rapido, semplice e non invasivo per la diagnosi precoce delle patologie mammarie, sviluppato a partire dall'analisi dell'intelligenza artificiale di decine di migliaia di test anonimi. A tal fine, quantusMM, compatibile con la maggior parte delle moderne macchine mammografiche, carica le immagini della scansione mammaria in due prospettive, cranio-caudale (CC) e medio-laterale obliqua (MLO), su una piattaforma digitale per l'analisi automatica. A partire da queste scansioni mammarie, l'algoritmo può rilevare la presenza di noduli e microcalcificazioni maligne in meno di due minuti, contribuendo così a identificare il rischio di cancro al seno.

La tecnologia dello strumento si basa sull'analisi quantitativa della texture dell'immagine mammaria; quantusMM classifica le immagini e le categorizza sulla base del sistema BI-RADS (Breast Imaging Reporting and Data System), che determina la probabilità di malignità nei seni scansionati. Questo sistema è diverso dalle categorie standard in quanto si basa sulla sensibilità piuttosto che sui valori predittivi positivi.

quantusMM è stato progettato come strumento per aiutare i professionisti del settore sanitario, in particolare nello screening di massa di pazienti con fattori di rischio, nella diagnosi precoce del tumore al seno e nella definizione delle priorità delle liste di attesa.

Altri test sviluppati da Transmural Biotech 

Insieme a quantusMM, Transmural Biotech ha sviluppato altri quattro test non invasivi basati sull'intelligenza artificiale che migliorano specificamente la capacità predittiva in una serie di malattie: quantusFLM, che prevede la capacità polmonare del feto, consentendo agli specialisti di definire i rischi e di preparare meglio il tempo e il luogo di nascita ottimali per ciascun piccolo paziente; quantusPrematurity, che utilizza ultrasuoni cervicali per prevedere il rischio di parto prematuro; quantusGL, che determina il livello di rischio di cecità dovuto al glaucoma e quantusSkin, che rileva lesioni della pelle maligne utilizzando immagini dermoscopiche. Questi test sono utilizzati in oltre 320 ospedali o centri specializzati in tutto il mondo.

Il test quantusSkin è stato incluso nel programma Breakthrough Devices della Federal Drug Agency (FDA) degli Stati Uniti. Questo programma mira a identificare e fornire ai pazienti e agli operatori sanitari tutti i dispositivi in grado di consentire una diagnosi o un trattamento efficaci di malattie potenzialmente mortali. L'FDA concluderà il processo nei prossimi mesi, concedendo allo strumento una licenza di commercializzazione per gli Stati Uniti.

Foto - https://mma.prnewswire.com/media/1943029/Transmural_quantusMM.jpg

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