Hiki i ka ho'āʻo koko hou ke wānana i ka holomua ʻana i ka maʻi Alzheimer

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Ua hoʻolaha ʻo Diadem Srl i kēia lā i ka hōʻoia CE IVD no kāna AlzoSure® Predict prognostic test test for the early prediction of Alzheimer's disease (AD). ʻO ka CE IVD (European Conformity In-Vitro Diagnostic Medical Devices) ka palapala hōʻoia e hiki ai iā Diadem ke lawe i ka hōʻike AlzoSure® Predict i ka mākeke ma UK a me nā ʻāina 27 o ka European Union (EU). Hiki iā ia ke hoʻomohala i ka mākeke ma ka hapa nui o ke koena o ka honua. ʻO ka AlzoSure® Predict kahi hoʻāʻo koko biomarker e hiki ke hoʻomaopopo me ka pololei kiʻekiʻe inā ʻo ka poʻe ma mua o 50 mau makahiki me nā hōʻailona o ka naʻau naʻau e holomua a ʻaʻole e holomua i ka maʻi Alzheimer a hiki i ʻeono makahiki ma mua o ka ʻike ʻia ʻana o nā hōʻailona.          

ʻO ka māka CE he koi kānāwai no ke kūʻai aku ʻana i nā lāʻau lapaʻau ma EU. Hāʻawi ia i ka hōʻoia maikaʻi no AlzoSure® Predict, e hōʻoia ana e hoʻokō ka hōʻike i nā koi koʻikoʻi o ka European In-Vitro Diagnostics Directive (98/79/EC). Ma hope o kēia ʻae ʻana i ka hāʻawi ʻana o ka US Food and Drug Administration i kahi Breakthrough Device Designation iā AlzoSure® Predict i Ianuali.

Kākoʻo ʻia ka ʻae ʻana o AlzoSure® Predict e nā ʻikepili lapaʻau maikaʻi mai kahi haʻawina lōʻihi 482-maʻi e hōʻike ana e hiki i ka hoʻāʻo ke ʻike inā e holomua a ʻaʻole paha nā kānaka i ka AD piha a hiki i ʻeono makahiki ma mua o ka ʻike ʻia ʻana o ka maʻi. ʻO ka poʻe maʻi he 50 mau makahiki a ʻoi paha i ka hoʻomaka ʻana o ke aʻo ʻana a me ka asymptomatic a i ʻole i ka wā mua o AD a i ʻole nā ​​​​dementias ʻē aʻe. Ua paʻi ʻia nā hopena haʻawina ma kahi preprint MedRxiv a ua waiho ʻia i kahi puke pai i nānā ʻia e nā hoa. ʻO ka papa ʻelua o kēia haʻawina, e komo pū ana ka ʻikepili biobank ma mua o 1,000 mau maʻi hou mai ʻEulopa a me US, e hoʻopau ʻia i nā mahina e hiki mai ana.

"ʻO kēia ʻae kānāwai mua no AlzoSure® Predict he hanana hōʻailona ia no kā mākou ʻepekema nona ka ʻike a me ka hoʻokō i hiki ai iā mākou ke hoʻokō i kēia milestone," wahi a Paul Kinnon, Luna Nui o Diadem. "Ke manaʻoʻiʻo nei mākou he holomua nui ia no ka miliona o nā maʻi a me ko lākou mau ʻohana ma ʻEulopa i ka pilikia mai ka maʻi o Alzheimer. E pōmaikaʻi ka ʻike mua i ka poʻe i ʻike ʻia ʻaʻole hiki ke neʻe i mua i ka AD a me kēlā poʻe i ʻike ʻia he pilikia, hiki iā lākou ke hana i kēia manawa e hoʻolōʻihi i ka holomua o ke ʻano. E hana pū mākou me nā mea lawelawe olakino e hōʻoia i ke komo ākea i AlzoSure® Predict a manaʻo e loaʻa ka hōʻike i nā kauka a me nā maʻi ma EU i nā mahina e hiki mai ana.

ʻO ka AlzoSure® Predict kahi hoʻāʻo biomarker e pili ana i ka plasma non-invasive e wānana pololei i ka hiki ke holomua ka mea maʻi ma mua o 50 mau makahiki me ka naʻau naʻau i ka dementia o Alzheimer. Hoʻohana ka ʻenehana o ka hui i kahi ʻano analytical e loaʻa ana kahi antibody proprietary a patented i hoʻomohala ʻia e Diadem i hoʻolālā ʻia e hoʻopaʻa iā U-p53AZ a me kāna mau ʻōkuhi. ʻO U-p53AZ kahi ʻano conformational o ka protein p53 i hoʻopili ʻia i ka pathogenesis o AD i nā haʻawina he nui.

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Linda Hohnholz

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