Sabon Gwajin Jini don Hasashen Farko Alzheimer

Diadem US, Inc., (wani reshen Diadem Srl) wani kamfani ne da ke haɓaka gwajin tushen jini na farko don hasashen farkon cutar Alzheimer (AD), a yau ya sanar da cewa Hukumar Abinci da Magunguna ta Amurka (FDA) ta ba da Nasarar Na'urar Na'urar Breakthrough. don AlzoSure® Predict, Diadem's tushen jini-based biomarker prognostic assay tsara don gane da high daidaito ko mutane fiye da shekaru 50 tare da alamun rashin fahimta za su ko ba za su ci gaba zuwa cutar Alzheimer har zuwa shekaru shida kafin ingantattun alamun bayyanar sun bayyana.

The FDA Breakthrough Designation an ba da ita ga sababbin na'urorin likitanci waɗanda ke da yuwuwar samar da ingantacciyar ganewar asali ko maganin cututtuka ko yanayi masu raɗaɗin rai ko maras muni. Ƙaddamarwar Na'urar Ƙarfafawa yana bawa kamfanoni damar cin gajiyar ƙarin shigarwar FDA yayin da suke aiki don tabbatar da aminci da ingancin na'urorin su yayin haɓakawa da kuma lokacin tsarin ƙaddamar da tsari, tare da sake dubawa da sauri da zarar kamfanin ya yi fayil don amincewa da tallace-tallace.

Aikace-aikacen Diadem ya sami goyan bayan ingantattun bayanai daga binciken dogon lokaci na haƙuri na 482 wanda ke nuna cewa AlzoSure® Predict na iya gano ko mutane za su ci gaba ko ba za su ci gaba zuwa cikakken AD ba har zuwa shekaru shida kafin cutar ta bayyana. Marasa lafiya sun kai shekaru 50 ko sama da haka a farkon binciken da asymptomatic ko a farkon matakan AD ko wasu lalata. An buga sakamakon binciken a cikin preprint na MedRxiv kuma an ƙaddamar da su zuwa mujallar da aka bita. Kashi na biyu na wannan binciken, wanda ya haɗa da bayanan bankin biobank akan ƙarin majinyata fiye da 1,000 daga Amurka da Turai, ya kamata a kammala cikin watanni masu zuwa.

Paul Kinnon, Shugaba na Diadem ya ce "Samun wannan FDA Breakthrough Device designation yana ƙarfafa ra'ayinmu cewa AlzoSure® Predict shine mai yuwuwar canza wasa don gano farkon ganewa da kuma kula da cutar Alzheimer, wanda ke damun miliyoyin marasa lafiya da iyalansu a dukan duniya," in ji Paul Kinnon, Shugaba na Diadem. "Muna ganin ƙaddamarwar Na'urar Ƙarfafawa a matsayin muhimmin mataki na tallafawa tallace-tallace na gaba na AlzoSure® Predict a Amurka da kuma duniya baki daya, kuma muna sa ran yin aiki tare da FDA don kammala karatun mu na asibiti da kuma hanzarta aiwatar da tsarin bita."

Diadem yana haɓaka ƙimar Hasashen AlzoSure® azaman mai sauƙi, gwajin biomarker na tushen plasma mara amfani don yin hasashen yuwuwar mai haƙuri sama da shekaru 50 tare da nakasar fahimi zai ci gaba zuwa lalatawar Alzheimer. Fasahar kamfanin tana amfani da hanyar nazari wanda ya haɗa da na'urar rigakafi ta mallaka da haƙƙin mallaka wanda Diadem ya ƙera kuma an ƙera shi don ɗaure zuwa U-p53AZ da jerin abubuwan da aka yi niyya. U-p53AZ wani nau'in nau'in nau'i ne na furotin p53 wanda ke da tasiri a cikin pathogenesis na AD a cikin binciken da yawa.