Ukuhlolwa Okusha Kwegazi Ukubikezela I-Alzheimer's Early

Ibhalwe ngu umhleli

Ukuhlolwa kwegazi lokuqala okubikezelwayo okungabikezela ukuqhubekela phambili okungenzeka kweSifo i-Alzheimer's kuze kufike eminyakeni eyi-6 kusengaphambili.

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I-Diadem US, Inc., (inkampani engaphansi kwe-Diadem Srl) inkampani eyenza ukuhlolwa kokuqala okusekelwe egazini kokubikezela kwangaphambili kwesifo i-Alzheimer's (AD), namuhla imemezele ukuthi i-US Food and Drug Administration (FDA) inikeze i-Breakthrough Device Designation. ku-AlzoSure® Predict, ukuhlolwa okusekelwe egazini kwe-biomarker ye-Diadem okuklanyelwe ukukhomba ngokunemba okuphezulu ukuthi abantu abangaphezu kweminyaka engama-50 abanezimpawu zokukhubazeka kwengqondo bazothuthukela noma ngeke bathuthukele esifweni se-Alzheimer kuze kube iminyaka eyisithupha ngaphambi kokuba kubonakale izimpawu eziqondile.

I-FDA Breakthrough Designation inikezwa emishinini yezokwelapha eyinoveli enamandla okuhlinzeka ngokuxilonga noma ukwelashwa okusongela ukuphila noma izifo noma izimo ezithena amandla ngokungenakulungiseka. Ukuqokwa kwe-Breakthrough Device kuvumela izinkampani ukuthi zihlomule kokokufaka okwengeziwe kwe-FDA njengoba zisebenzela ukuqinisekisa ukuphepha nokusebenza ngempumelelo kwamadivayisi azo ngesikhathi sokuthuthukiswa naphakathi nenqubo yokuhambisa yokulawula, ngokubuyekezwa okusheshisiwe uma inkampani isifake amafayela ukuze kugunyazwe ukumaketha.

Isicelo sikaDiadem sasekelwa idatha evumayo evela ocwaningweni lwesikhathi eside lweziguli ezingama-482 olubonisa ukuthi i-AlzoSure® Predict ingakwazi ukuhlonza ukuthi abantu bazothuthukela ku-AD ephelele kuze kube iminyaka eyisithupha ngaphambi kokuba kubonakale ukugula. Iziguli zazineminyaka yobudala engama-50 noma ngaphezulu ekuqaleni kocwaningo futhi zingenazimpawu noma ezigabeni zokuqala ze-AD noma okunye ukuwohloka komqondo. Imiphumela yocwaningo ishicilelwe ku-MedRxiv preprint futhi ihanjiswe kujenali ebuyekezwe ngontanga. Isigaba sesibili salolu cwaningo, esihlanganisa idatha ye-biobank ezigulini ezengeziwe ezingaphezu kwe-1,000 ezivela e-US naseYurophu, kufanele siphothulwe ezinyangeni ezizayo.

“Ukuthola lesi sihloko se-FDA Breakthrough Device kuqinisa umbono wethu wokuthi i-AlzoSure® Predict ingase iguqule umdlalo ekuhlonzweni nasekulawuleni isifo i-Alzheimer’s, esihlupha izigidi zeziguli nemindeni yazo emhlabeni wonke,” kusho uPaul Kinnon, oyi-CEO ye-Diadem. "Sibona ukuqokwa kwe-Breakthrough Device njengesinyathelo esibalulekile ekusekeleni ukuthengiswa kwe-AlzoSure® Predict e-US nasemhlabeni jikelele, futhi sibheke ngabomvu ukusebenzisana eduze ne-FDA ukuze siqedele izifundo zethu zomtholampilo futhi sisheshise inqubo yokubuyekezwa kokulawula."

I-Diadem ithuthukisa i-AlzoSure® Predict assay njengokuhlola kwe-biomarker okusekelwe ku-plasma okulula, okungahlaseli ukubikezela ngokunembile amathuba okuthi isiguli esineminyaka engaphezu kwengu-50 esinokukhubazeka kwengqondo sithuthukele ekuwohlokeni komqondo kwe-Alzheimer. Ubuchwepheshe benkampani busebenzisa indlela yokuhlaziya ehlanganisa i-antibody enegunya lobunikazi eyakhiwe yi-Diadem futhi eklanyelwe ukuhlanganisa i-U-p53AZ nokulandelana kwayo okuqondiwe. I-U-p53AZ iwuhlobo oluhambisanayo lweprotheyini ye-p53 efakwe ku-pathogenesis ye-AD ezifundweni eziningi.

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