Mayeso Atsopano a Magazi Kuti Aneneretu Alzheimer's Early

Written by mkonzi

Kuyeza koyamba kwamagazi komwe kungathe kulosera za matenda a Alzheimer's mpaka zaka 6 pasadakhale.

Sangalalani, PDF ndi Imelo

Diadem US, Inc., (yomwe ndi gawo la Diadem Srl) kampani yomwe ikupanga mayeso oyamba otengera magazi kuneneratu koyambirira kwa matenda a Alzheimer's (AD), lero yalengeza kuti US Food and Drug Administration (FDA) yapereka Kusankhidwa kwa Chipangizo cha Breakthrough Device. for AlzoSure® Predict, Diadem's blood-based biomarker prognostic assay yopangidwa kuti izindikire molondola kwambiri ngati anthu azaka zopitilira 50 omwe ali ndi zizindikiro za vuto lachidziwitso adzakula kapena sadzapita ku matenda a Alzheimer's mpaka zaka zisanu ndi chimodzi zizindikiro zotsimikizika zisanawonekere.

Dongosolo la FDA Breakthrough Designation limaperekedwa ku zida zatsopano zamankhwala zomwe zimatha kupereka chithandizo chamankhwala chothandiza kwambiri pakuzindikira kapena kuchiza matenda omwe ali pachiwopsezo cha moyo kapena matenda osachiritsika. Kutchulidwa kwa Breakthrough Device kumalola makampani kuti apindule ndi zowonjezera za FDA pamene akugwira ntchito kuti atsimikizire chitetezo ndi mphamvu za zipangizo zawo panthawi ya chitukuko komanso panthawi ya kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe ka kayendetsedwe kake.

Kugwiritsa ntchito kwa Diadem kunathandizidwa ndi deta yabwino yochokera ku kafukufuku wautali wa odwala 482 omwe akuwonetsa kuti AlzoSure® Predict imatha kuzindikira ngati anthu apitirire ku AD yokwanira mpaka zaka zisanu ndi chimodzi matendawa asanawonekere. Odwala anali azaka za 50 kapena kupitilira apo poyambira phunzirolo komanso 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 kafukufukuyu, lomwe limaphatikizapo data ya biobank pa odwala owonjezera a 1,000 ochokera ku US ndi Europe, ikuyenera kumalizidwa m'miyezi ikubwerayi.

"Kupeza dzina ili la FDA Breakthrough Device kumalimbitsa malingaliro athu kuti AlzoSure® Predict ndi njira yosinthira masewera kuti adziwe msanga komanso kuwongolera matenda a Alzheimer's, omwe amasautsa mamiliyoni a odwala ndi mabanja awo padziko lonse lapansi," atero a Paul Kinnon, CEO wa Diadem. "Tikuwona kutchulidwa kwa Chipangizo cha Breakthrough ngati gawo lofunikira pothandizira kutsatsa kwamtsogolo kwa AlzoSure® Predict ku US komanso padziko lonse lapansi, ndipo tikuyembekeza kugwirira ntchito limodzi ndi a FDA kuti timalize maphunziro athu azachipatala ndikufulumizitsa kuwunikiranso malamulo."

Diadem ikupanga AlzoSure® Predict assay ngati kuyesa kosavuta, kosagwiritsa ntchito plasma-based biomarker kuneneratu molondola kuthekera kwakuti wodwala wazaka zopitilira 50 yemwe ali ndi vuto lozindikira amatha kupita ku Alzheimer's dementia. Ukadaulo wa kampaniyi umagwiritsa ntchito njira yowunikira yomwe imaphatikizapo anti-antibody komanso ovomerezeka opangidwa ndi Diadem ndipo adapangidwa kuti amangirire ku U-p53AZ ndi zomwe amatsata. U-p53AZ ndi mtundu wosinthika wa protein ya p53 yomwe yakhudzidwa ndi kufalikira kwa AD m'maphunziro angapo.

Sangalalani, PDF ndi Imelo

Ponena za wolemba

mkonzi

Mkonzi wamkulu wa eTurboNew ndi Linda Hohnholz. Amakhala ku eTN HQ ku Honolulu, Hawaii.

Siyani Comment

eTurboNews | | Mbiri ya TravelIndustry