Muedzo weRopa Nyowani Kufanotaura Kwekutanga Alzheimer's

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Yekutanga prognostic yeropa bvunzo iyo inogona kufanotaura kufambira mberi kwechirwere cheAlzheimer kusvika kumakore matanhatu pamberi.

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Diadem US, Inc., (inotsigira Diadem Srl) kambani inogadzira yekutanga-yakavakirwa ropa bvunzo yekufungidzira kwekutanga kwechirwere cheAlzheimer's (AD), nhasi yazivisa kuti US Food and Drug Administration (FDA) yakapa Breakthrough Chishandiso Dhizaini. yeAlzoSure® Predict, Diadem's blood-based biomarker prognostic assay yakagadzirirwa kuona nehuchenjeri hwepamusoro kana vanhu vari pamusoro pemakore makumi mashanu vane zviratidzo zvekukanganisika kwenjere vachazoenda kuchirwere cheAlzheimer kusvika kumakore matanhatu zviratidzo zvechokwadi zvisati zvaonekwa.

Iyo FDA Breakthrough Dhizaini inopihwa kune zvitsva zvekurapa zvigadziriso zvine mukana wekupa zvakanyanya kuongororwa kana kurapwa kwezvirwere zvinotyisidzira hupenyu kana zvisinga gadziriswe zvinoremadza kana mamiriro. Iyo Breakthrough Chishandiso kudomwa inobvumira makambani kuti abatsirwe kubva kune yekuwedzera FDA yekuisa pavanenge vachishanda kusimbisa kuchengetedzeka uye kushanda kwemidziyo yavo panguva yekuvandudza uye panguva yekudzora kuendesa maitiro, nekuchimbidza wongororo kana kambani ikafaira mvumo yekushambadzira.

Chikumbiro chaDiadem chakatsigirwa nedata rakanaka kubva muongororo ye482-murwere kwenguva refu inoratidza kuti AlzoSure® Predict inogona kuona kana vanhu vachizoenda kuAD yakazara kusvika makore matanhatu chirwere chisati chaonekwa. Varwere vaive vakura 50 makore kana kupfuura pakutanga kwechidzidzo uye asymptomatic kana pamatanho ekutanga eAD kana mamwe dementias. Mhedzisiro yezvidzidzo yakaburitswa muMedRxiv preprint uye yakaendeswa kune rimwe bhuku rinoongororwa nevezera. Chikamu chechipiri chechidzidzo ichi, icho chinosanganisira biobank data pane vanopfuura chiuru chevamwe varwere kubva kuUS neEurope, chiri kuda kupedzwa mumwedzi iri kuuya.

"Kuwana iyi FDA Breakthrough Device zita rinosimbisa maonero edu ekuti AlzoSure® Predict inogona kushandura mutambo wekutanga kuzivikanwa uye kutonga kwechirwere cheAlzheimer, icho chinotambudza mamirioni evarwere nemhuri dzavo pasi rose," akadaro Paul Kinnon, CEO weDiadem. "Tinoona kudomwa kweBreakthrough Device sedanho rakakosha mukutsigira kushambadzira kweAlzoSure® Predict muUS nepasi rose, uye isu tinotarisira kushanda pamwe neFDA kuti tipedze zvidzidzo zvedu zvekiriniki uye nekukasira maitiro ekuongorora."

Diadem iri kugadzira iyo AlzoSure® Predict assay seyakapusa, isiri-invasive plasma-based biomarker bvunzo kunyatsofanotaura mukana wekuti murwere ane makore anopfuura makumi mashanu ane hurema hwekuziva anofambira mberi kusvika kuAlzheimer's dementia. Tekinoroji yekambani iyi inoshandisa nzira yekuongorora inosanganisira antibody uye ine patented antibody yakagadziridzwa neDiadem uye yakagadzirirwa kusunga kuU-p50AZ uye kutevedzana kwayo. U-p53AZ inosiyana-siyana yeprotein yep53 iyo yakabatanidzwa mupathogenesis yeAD mune zvidzidzo zvakawanda.

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Mupepeti mukuru we eTurboNew ndiLinda Hohnholz. Iye anogara muTN HQ muHonolulu, Hawaii.

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