Teko e Ncha ea Mali ho bolela esale pele lefu la Alzheimer's

ngotsoeng ke mohlophisi

Teko ea pele ea mali e ka bolelang tsoelo-pele ea lefu la Alzheimer ho fihlela lilemo tse 6 esale pele.

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Diadem US, Inc., (karolelano ea Diadem Srl) k'hamphani e nts'etsapele tlhahlobo ea pele ea mali bakeng sa bonohe ba pele ba lefu la Alzheimer's (AD), kajeno e phatlalalitse hore US Food and Drug Administration (FDA) e file Breakthrough Device Designation. bakeng sa AlzoSure® Predict, Diadem's biomarker prognostic assay e thehiloeng maling e etselitsoeng ho tsebahatsa ka nepo e phahameng hore na batho ba kaholimo ho lilemo tse 50 ba nang le matšoao a bokooa ba kelello ba tla fetela lefung la Alzheimer ho fihlela lilemo tse ts'eletseng pele matšoao a hlakileng a bonahala.

FDA Breakthrough Designation e fuoa lisebelisoa tse ncha tsa bongaka tse nang le monyetla oa ho fana ka tlhahlobo e sebetsang haholoanyane kapa kalafo ea mafu a behang bophelo kotsing kapa a holofatsa ka tsela e ke keng ea lokisoa. Lebitso la Breakthrough Device le lumella lik'hamphani ho rua molemo ho tsoa ho tlatsetso ea FDA ha li ntse li sebeletsa ho netefatsa polokeho le katleho ea lisebelisoa tsa tsona nakong ea nts'etsopele le nakong ea ts'ebetso ea ho fana ka taolo, ka tlhahlobo e potlakileng hang ha k'hamphani e fana ka tumello ea ho bapatsa.

Kopo ea Diadem e ne e tšehetsoa ke lintlha tse ntle tse tsoang phuputsong ea nako e telele ea mokuli ea 482 e bontšang hore AlzoSure® Predict e ka tseba hore na batho ba tla tsoela pele kapa ba ke ke ba fetela ho AD e feletseng ho fihlela lilemo tse tšeletseng pele boloetse bo bonahala. Bakuli ba ne ba le lilemo li 50 kapa ho feta qalong ea thuto, 'me ba ne ba se na matšoao kapa qalong ea AD kapa dementia e meng. Liphetho tsa boithuto li phatlalalitsoe khatisong ea pele ea MedRxiv mme li rometsoe koranteng e hlahlobiloeng ke lithaka. Karolo ea bobeli ea thuto ena, e kenyelletsang lintlha tsa biobank ho bakuli ba eketsehileng ba 1,000 ba tsoang US le Europe, e lokela ho phethoa likhoeling tse tlang.

"Ho fumana lebitso lena la FDA Breakthrough Device ho tiisa pono ea rona ea hore AlzoSure® Predict ke ntho e ka fetolang papali bakeng sa ho tsebahatsa le ho laola lefu la Alzheimer's, le hlaselang bakuli ba limilione le malapa a bona lefatšeng ka bophara," ho boletse Paul Kinnon, CEO oa Diadem. "Re bona khetho ea Sesebelisoa sa Breakthrough e le mohato oa bohlokoa ho ts'ehetsa khoebo ea nako e tlang ea AlzoSure® Predict naheng ea Amerika le lefats'e ka bophara, 'me re lebelletse ho sebetsa haufi-ufi le FDA ho phethela lithuto tsa rona tsa bongaka le ho akofisa tšebetso ea tlhahlobo ea taolo."

Diadem e ntse e etsa tlhahlobo ea AlzoSure® Predict e le tlhahlobo e bonolo, e sa hlaseleng e thehiloeng ho plasma ea biomarker ho bolela esale pele ka nepo monyetla oa hore mokuli ea lilemo tse fetang 50 ea nang le bokooa ba kelello a hatele pele ho dementia ea Alzheimer. Theknoloji ea k'hamphani e sebelisa mokhoa oa ho hlahloba o kenyelletsang antibody e nang le litokelo le patente e entsoeng ke Diadem mme e etselitsoe ho tlama ho U-p53AZ le tatellano ea eona. U-p53AZ ke mofuta o fapaneng oa protheine ea p53 e kenyellelitsoeng ho pathogenesis ea AD lithutong tse ngata.

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mohlophisi

Mohlophisi e moholo oa eTurboNew ke Linda Hohnholz. O lula ntlong e kholo ea eTN e Honolulu, Hawaii.

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