Nlele Ọbara ọhụrụ iji buru amụma mmalite Alzheimer

Nyocha ọbara nke mbụ nke nwere ike ibu amụma na ọ ga-enwe ọganihu na ọrịa Alzheimer ruo afọ 6 tupu oge eruo.

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Diadem US, Inc., (onye enyemaka nke Diadem Srl) ụlọ ọrụ na-emepụta ule mbụ dabere na ọbara maka amụma mmalite nke ọrịa Alzheimer (AD), taa mara ọkwa na US Food and Drug Administration (FDA) enyela Breakthrough Device Designation. maka AlzoSure® Predict, Diadem's blood based biomarker prognostic assay e mere iji mata n'ụzọ ziri ezi ma ndị mmadụ karịrị afọ 50 nwere ihe ịrịba ama nke enweghị ọgụgụ isi ga-enwe ma ọ bụ agaghị enwe ọganihu na ọrịa Alzheimer ruo afọ isii tupu apụta ihe mgbaàmà doro anya.

Emebere FDA Breakthrough Designation maka ngwaọrụ ahụike ọhụụ nwere ikike ịnye nyocha ma ọ bụ ọgwụgwọ dị mma nke ọrịa ma ọ bụ ọnọdụ ndị na-eyi ndụ egwu ma ọ bụ enweghị mgbagha. Nhazi ngwaọrụ Breakthrough na-enye ohere ka ụlọ ọrụ nweta uru site na ntinye FDA ọzọ ka ha na-arụ ọrụ iji kwado nchekwa na ịdị irè nke ngwaọrụ ha n'oge mmepe na n'oge usoro ntinye iwu, na nyocha ngwa ngwa ozugbo faịlụ ụlọ ọrụ maka nkwado ahịa.

Ngwa Diadem kwadoro site na data ziri ezi sitere na nyocha ogologo oge nke ndị ọrịa 482 na-egosi na AlzoSure® Predict nwere ike ịchọpụta ma ndị mmadụ n'otu n'otu ga-enwe ọganihu ma ọ bụ na ha agaghị enwe ọganihu ruo AD zuru oke ruo afọ isii tupu ọrịa ahụ apụta. Ndị ọrịa dị afọ 50 ma ọ bụ karịa na mmalite nke ọmụmụ ihe na asymptomatic ma ọ bụ na mmalite nke AD ma ọ bụ dementias ndị ọzọ. Ebipụtara nsonaazụ ọmụmụ na ndebiri MedRxiv ma nyefee ya na akwụkwọ akụkọ nyochara ndị ọgbọ. Usoro nke abụọ nke ọmụmụ a, nke gụnyere data biobank na ihe karịrị 1,000 ndị ọrịa ọzọ sitere na US na Europe, bụ maka imecha n'ime ọnwa ndị na-abịa.

"Inweta nke a FDA Breakthrough Device designation na-emesi echiche anyị ike na AlzoSure® Predict bụ ihe nwere ike ịgbanwe egwuregwu maka nchọpụta mmalite na njikwa ọrịa Alzheimer, nke na-emetụta ọtụtụ nde ndị ọrịa na ezinụlọ ha n'ụwa nile," ka Paul Kinnon, CEO nke Diadem kwuru. "Anyị na-ahụ nhọpụta ngwaọrụ Breakthrough dị ka nzọụkwụ dị mkpa n'ịkwado azụmahịa n'ọdịnihu nke AlzoSure® Predict na US na n'ụwa nile, anyị na-atụkwa anya ka anyị na FDA na-arụkọ ọrụ ọnụ iji mechaa ọmụmụ ụlọ ọgwụ anyị ma mee ka usoro nyocha usoro iwu dịkwuo ngwa."

Diadem na-etolite nyocha amụma AlzoSure® dị ka nnwale biomarker dị mfe, na-abụghị nke na-emetụta plasma iji buru amụma nke ọma na onye ọrịa gafere afọ 50 nwere nkwarụ ọgụgụ isi ga-aga n'ihu na dementia Alzheimer. Teknụzụ ụlọ ọrụ ahụ na-eji usoro nyocha nke gụnyere ihe mgbochi nwere ikike na ikike nke Diadem mepụtara wee kee ya iji jikọta U-p53AZ na usoro ebumnuche ya. U-p53AZ bụ mgbanwe mgbanwe nke protein p53 nke etinyere na pathogenesis nke AD n'ọtụtụ ọmụmụ.

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Onye nchịkọta akụkọ nke eTurboNew bụ Linda Hohnholz. Ọ dabere na eTN HQ na Honolulu, Hawaii.

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