Kuyesedwa Kwatsopano Kwa Magazi Kutha Kuneneratu Kukula Kwambiri kwa Alzheimer's

Diadem Srl lero yalengeza za certification ya CE IVD pamayeso ake a AlzoSure® Predict prognostic blood for kuneneratu koyambirira kwa matenda a Alzheimer's (AD). Satifiketi ya CE IVD (European Conformity In-Vitro Diagnostic Medical Devices) imalola Diadem kutenga mayeso a AlzoSure® Predict kukagulitsa ku UK ndi mayiko 27 a European Union (EU). Zimathandiziranso chitukuko cha msika padziko lonse lapansi. AlzoSure® Predict ndi mayeso a magazi a biomarker omwe amatha kuzindikira molondola kwambiri ngati anthu azaka zopitilira 50 omwe ali ndi zizindikiro za vuto lachidziwitso sangapitirire ku matenda a Alzheimer's mpaka zaka zisanu ndi chimodzi zizindikiro zotsimikizika zisanawonekere.          

Chizindikiro cha CE ndichofunikira mwalamulo pakutsatsa zida zamankhwala ku EU. Amapereka chitsimikizo cha khalidwe la AlzoSure® Predict, kutsimikizira kuti mayeserowo akukwaniritsa zofunikira za European In-Vitro Diagnostics Directive (98/79/EC). Kuvomerezeka uku kukutsatira bungwe la US Food and Drug Administration lomwe linapereka mphoto ya Breakthrough Device Designation ku AlzoSure® Predict mu Januwale.

Kuvomerezeka kwa AlzoSure® Predict kumathandizidwa ndi chidziwitso chachipatala chochokera ku kafukufuku wautali wa odwala 482 omwe akuwonetsa kuti mayesowo amatha kuzindikira ngati anthuwo akupita ku AD yathunthu mpaka zaka zisanu ndi chimodzi matendawa asanawonekere. Odwala anali ndi zaka 50 kapena kuposerapo kumayambiriro kwa phunzirolo ndi asymptomatic kapena koyambirira kwa AD kapena matenda ena a dementia. Zotsatira zaphunziro zidasindikizidwa m'chithunzi choyambirira cha MedRxiv ndipo zatumizidwa ku magazini yowunikiridwa ndi anzawo. Gawo lachiwiri la phunziroli, lomwe limaphatikizapo deta ya biobank pa odwala owonjezera a 1,000 ochokera ku Ulaya ndi US, idzatsirizidwa m'miyezi ikubwerayi.

"Chivomerezo choyamba ichi cha AlzoSure® Predict ndi chizindikiro kwa asayansi athu omwe kuzindikira kwawo ndi kudzipereka kwawo kwatithandiza kukwaniritsa izi," anatero Paul Kinnon, CEO wa Diadem. "Tikukhulupirira kuti zikuyimira kupita patsogolo kwakukulu kwa odwala mamiliyoni ambiri ndi mabanja awo ku Europe omwe ali pachiwopsezo cha matenda a Alzheimer's. Chidziwitso choyambirira chidzapindulitsa iwo omwe apezeka kuti sangapite ku AD komanso anthu omwe apezeka kuti ali pachiopsezo, omwe tsopano angathe kuchitapo kanthu kuti achepetse kupitirira kwa matendawa. Tikhala tikuthandizana ndi othandizira azaumoyo osiyanasiyana kuti tiwonetsetse kuti AlzoSure® Predict ikupezeka ndipo tikuyembekeza kuti mayesowo apezeka kwa madokotala ndi odwala ku EU m'miyezi ikubwerayi. "

AlzoSure® Predict ndi mayeso osasokoneza a plasma-based biomarker kuti adziwike molondola za kuthekera kwakuti wodwala wazaka zopitilira 50 yemwe ali ndi vuto lozindikira amatha kupita ku Alzheimer's dementia. Ukadaulo wa kampaniyo umagwiritsa ntchito njira yowunikira yomwe imaphatikizapo anti-antibody komanso ovomerezeka opangidwa ndi Diadem opangidwa kuti amangirire ku U-p53AZ ndi zomwe amatsata. U-p53AZ ndi mtundu wosinthika wa protein ya p53 yomwe yakhudzidwa ndi matenda a AD m'maphunziro angapo.