Kev kuaj ntshav tshiab los kwv yees Early Alzheimer's

Diadem US, Inc., (ib lub koom haum ntawm Diadem Srl) a tsim thawj qhov kev kuaj ntshav rau kev kwv yees ntxov ntawm Alzheimer's disease (AD), hnub no tshaj tawm tias US Food and Drug Administration (FDA) tau tso cai Breakthrough Device Designation for AlzoSure® Predict, Diadem's blood-based biomarker prognostic assay tsim los txheeb xyuas. nrog qhov tseeb siab txawm tias cov tib neeg muaj hnub nyoog 50 xyoo uas muaj cov tsos mob ntawm kev paub tsis meej yuav lossis yuav tsis tuaj yeem mus rau Alzheimer's kab mob mus txog rau xyoo ua ntej cov tsos mob tshwm sim.

FDA Breakthrough Designation tau tso cai rau cov cuab yeej kho mob tshiab uas muaj peev xwm los muab kev kuaj mob zoo dua lossis kev kho mob ntawm txoj sia lossis kev tsis tuaj yeem cuam tshuam cov kab mob lossis cov xwm txheej. Lub Breakthrough Device designation tso cai rau cov tuam txhab tau txais txiaj ntsig los ntawm FDA cov tswv yim ntxiv thaum lawv ua haujlwm kom muaj kev nyab xeeb thiab kev ua tau zoo ntawm lawv cov khoom siv thaum lub sij hawm txhim kho thiab nyob rau hauv cov txheej txheem kev tswj hwm, nrog kev tshuaj xyuas sai sai thaum lub tuam txhab cov ntaub ntawv rau kev pom zoo.

Diadem daim ntawv thov tau txais kev txhawb nqa los ntawm cov ntaub ntawv zoo los ntawm 482-tus neeg mob ntev txoj kev tshawb fawb qhia tias AlzoSure® Predict tuaj yeem txheeb xyuas seb cov tib neeg puas yuav lossis yuav tsis nce mus rau AD tag nrho txog rau rau xyoo ua ntej qhov mob tshwm sim. Cov neeg mob muaj hnub nyoog 50 xyoo lossis tshaj saud thaum pib ntawm kev tshawb fawb thiab asymptomatic lossis thaum ntxov ntawm AD lossis lwm yam dementias. Cov txiaj ntsig ntawm kev tshawb fawb tau luam tawm nyob rau hauv MedRxiv preprint thiab tau xa mus rau ib phau ntawv txheeb xyuas cov phooj ywg. Qhov thib ob ntawm txoj kev tshawb no, uas suav nrog cov ntaub ntawv biobank ntawm ntau dua 1,000 tus neeg mob ntxiv los ntawm Asmeskas thiab Europe, yuav tsum ua tiav nyob rau lub hlis tom ntej.

Paul Kinnon, CEO ntawm Diadem tau hais tias "Kev tau txais qhov FDA Breakthrough Device designation txhawb peb txoj kev xav tias AlzoSure® Predict yog qhov hloov pauv kev ua si rau kev txheeb xyuas ntxov thiab kev tswj hwm tus kab mob Alzheimer's, uas cuam tshuam ntau lab tus neeg mob thiab lawv tsev neeg thoob ntiaj teb," said Paul Kinnon, CEO ntawm Diadem. "Peb pom kev tsim cov cuab yeej Breakthrough yog ib kauj ruam tseem ceeb hauv kev txhawb nqa kev lag luam yav tom ntej ntawm AlzoSure® Predict hauv Asmeskas thiab thoob ntiaj teb, thiab peb tos ntsoov yuav ua haujlwm ze nrog FDA los ua kom tiav peb cov kev tshawb fawb soj ntsuam thiab nrawm cov txheej txheem tshuaj xyuas. "

Diadem tab tom txhim kho AlzoSure® Predict assay raws li qhov yooj yim, tsis muaj kev cuam tshuam plasma-based biomarker kuaj kom raug kwv yees qhov tshwm sim uas tus neeg mob hnub nyoog tshaj 50 xyoo nrog kev paub tsis meej yuav ua rau Alzheimer's dementia. Lub tuam txhab thev naus laus zis siv cov txheej txheem tshuaj ntsuam xyuas uas suav nrog cov tshuaj tiv thaiv tus kheej thiab patented tsim los ntawm Diadem thiab tsim los khi rau U-p53AZ thiab nws cov phiaj xwm ua ntu zus. U-p53AZ yog ib tug conformational variant ntawm p53 protein uas tau cuam tshuam nyob rau hauv lub pathogenesis ntawm AD nyob rau hauv ntau yam kev tshawb fawb.

Print Friendly, PDF & Email

Xov Xwm Lwm Yam