Uvavanyo olutsha lokuphucula ukuxilongwa kwesifo i-Alzheimer's

I-US Food and Drug Administration namhlanje ivumele ukuthengiswa kovavanyo lokuqala lokuxilonga kwi-vitro ukuze kubonwe kwangethuba iiplagi ze-amyloid ezinxulumene nesifo se-Alzheimer. Uvavanyo lwe-Lumipulse G β-Amyloid Ratio (1-42 / 1-40) lujoliswe ukuba lusetyenziswe kwizigulane zabantu abadala, abaneminyaka engama-55 ubudala nangaphezulu, ababonisa ukuphazamiseka kwengqondo abavavanyelwa isifo se-Alzheimer kunye nezinye izizathu zokuncipha kwengqondo.           

"Ubukho bovavanyo lokuxilonga lwe-in vitro olunokuphelisa isidingo sokuthatha ixesha kunye neendleko ze-PET scans ziindaba ezimnandi kubantu kunye neentsapho ezichaphazelekayo malunga nokuxilongwa kwesifo se-Alzheimer," kusho uJeff Shuren, MD, JD, umlawuli. yeZiko le-FDA leZixhobo kunye neMpilo yeRadiological. “Ngovavanyo lweLumipulse, kukho indlela entsha enokuthi igqitywe kwangolo suku lunye kwaye inokunika oogqirha ulwazi olufanayo malunga nemeko ye-brain amyloid, ngaphandle komngcipheko wemitha, ukunceda ukufumanisa ukuba ukukhubazeka kwengqondo kwesigulana kungenxa yesifo sika-Alzheimer. ”

Ngokutsho kwamaZiko ezeMpilo eSizwe, abantu baseMelika abangaphezu kwezigidi ezithandathu, abaninzi abaneminyaka engama-65 okanye ngaphezulu, banokuba nesifo sengqondo esiyingozi esibangelwa sisifo i-Alzheimer's, ukuphazamiseka kwengqondo ekwaziwa ngokutshabalalisa imemori kunye nokucinga, kwaye, ekugqibeleni, ukukwazi ukuphumeza. eyona misebenzi ilula. Kubantu abaninzi abanesifo sika-Alzheimer, iimpawu zeklinikhi ziqala ukuvela kamva ebomini. 

Isifo sika-Alzheimer siyakhula, nto leyo ethetha ukuba esi sifo siya sisiba mandundu ngokuhamba kwexesha. Ukuxilongwa kwangaphambili kunye nokuchanekileyo kubalulekile ukunceda izigulane kunye nabanonopheli ngokucwangcisa kunye neendlela zonyango zakwangoko. Kukho imfuno engafezekanga yovavanyo oluthembekileyo nolukhuselekileyo olunokuchonga ngokuchanekileyo izigulane ezine-amyloid plaques ezihambelana nesifo se-Alzheimer. Nangona i-amyloid plaques ingenzeka kwezinye izifo, ukukwazi ukubona ubukho be-plaque, kunye nolunye uphononongo, kunceda ugqirha ukuba abone isizathu esinokwenzeka seempawu zesigulane kunye neziphumo. Ngaphambi kokugunyaziswa kwanamhlanje, oogqirha basebenzisa i-positron emission tomography (PET) i-scans, inketho enokuba yindleko kwaye inzima, ukufumanisa / ukujonga amacwecwe e-amyloid kwingqondo yesigulane, ngokuphindaphindiweyo iminyaka ngaphambi kokuqala kwesifo seklinikhi, ukuncedisa ekuxilongeni isifo se-Alzheimer.

Uvavanyo lweLumipulse luhloselwe ukulinganisa umlinganiselo we-β-amyloid 1-42 kunye ne-β-amyloid 1-40 (iiprotheyini ezithile ezinokuqokelela kwaye zenze iiplaques) i-concentrations efunyenwe kwi-cerebral spinal fluid (CSF), enokunceda oogqirha baqonde ukuba ngaba isigulane sinokuba neeplaque ze-amyloid, uphawu oluphawulekayo lwe-Alzheimer's disease. Iziphumo kufuneka zitolikwe ngokudibeneyo nolunye ulwazi lwezonyango lwesigulane.

Isiphumo sovavanyo se-Lumipulse G β-amyloid (1-42 / 1-40) sihambelana nobukho be-amyloid plaques, efana nento eya kubonwa kwi-PET scan. Isiphumo esibi siyahambelana nesiphumo se-PET scan esine-amyloid. Isiphumo sovavanyo esibi sinciphisa amathuba okuba ukukhubazeka kwengqondo yesigulane kubangelwa sisifo sika-Alzheimer, esenza ukuba oogqirha balandele ezinye izizathu zokuncipha kwengqondo kunye nesifo sengqondo esiyingozi. Uvavanyo alujoliswanga njengovavanyo okanye uvavanyo lokuxilonga oluzimeleyo. Kukwakho ukuba kunokwenzeka ukuba iziphumo zovavanyo oluqinisekileyo zinokubonwa kwizigulane ezinezinye iintlobo zeemeko ze-neurologic, kunye nabantu abadala abasempilweni ngokwengqondo, nto leyo egxininisa ukubaluleka kokusebenzisa olu vavanyo ngokubambisana nolunye uvavanyo lwezonyango. 

I-FDA ivavanye ukhuseleko kunye nokusebenza kolu vavanyo kuphononongo lweklinikhi lweesampulu ze-CSF ezingama-292 ezivela kwi-Alzheimer's Disease Neuroimaging Initiative yesampulu yebhanki. Iisampuli zavavanywa nguLumipulse G β-amyloid Ratio (1-42 / 1-40) kwaye xa kuthelekiswa neziphumo ze-PET scan ye-amyloid. Kulo cwaningo lweklinikhi, i-97% yabantu abane-Lumipulse G β-amyloid Ratio (1-42 / 1-40) iziphumo ezintle babe nobukho be-amyloid plaques nge-PET scan kunye ne-84% yabantu abaneziphumo ezibi babe ne-PET scan ye-amyloid. .

Imingcipheko enxulumene neLumipulse G β-amyloid Ratio (1-42/1-40) ubukhulu becala yinto enokwenzeka yeziphumo zovavanyo olungeyonyani kunye nobuxoki obungalunganga. Iziphumo ezilungileyo zobuxoki, ngokubambisana nolunye ulwazi lweklinikhi, kunokukhokelela ekuxilongweni okungafanelekanga, kunye nonyango olungeyomfuneko, isifo se-Alzheimer. Oku kunokukhokelela kuxinzelelo lwengqondo, ukulibaziseka ekufumaneni uxilongo oluchanekileyo kunye neendleko kunye nomngcipheko weziphumo ebezingalindelekanga ezivela kunyango olungeyomfuneko. Iziphumo zovavanyo ezingezizo zobuxoki zinokukhokelela kuvavanyo olongezelelweyo olungeyomfuneko kunye nokulibaziseka okunokwenzeka kunyango olusebenzayo. Okubalulekileyo, i-Lumipulse G β-amyloid Ratio (1-42 / 1-40) ayilona uvavanyo oluzimeleyo kunye nezinye iimvavanyo zeklinikhi okanye iimvavanyo ezongezelelweyo kufuneka zisetyenziswe ukuchonga iindlela zonyango. 

I-FDA iphonononge isixhobo ngokusebenzisa indlela yokuphononongwa kwe-De Novo ye-premarket, indlela yokulawula izixhobo ezisezantsi ukuya kwimodareyitha yengozi yohlobo olutsha. Esi senzo sidala ulwahlulo olutsha olulawulayo, oluthetha ukuba izixhobo ezilandelayo zohlobo olufanayo ezinenjongo efanayo zokusetyenziswa zinokuhamba ngenkqubo yentengiso ye-FDA's 510(k), apho izixhobo zinokufumana isigunyaziso sentengiso ngokubonisa ukulingana okukhulu kwisixhobo se-predicate.

I-Lumipulse G β-amyloid Ratio (1-42 / 1-40) inikwe i-Breakthrough Device device, inkqubo eyenzelwe ukukhawuleza uphuhliso kunye nokuhlaziywa kwezixhobo ezinokubonelela ngonyango olusebenzayo okanye ukuxilongwa kwezifo ezisongela ubomi okanye ezingenakuguqulwa. okanye iimeko.

I-FDA ivumele ukuthengiswa kweLumipulse G ß-Amyloid Ratio (1-42/1-40) ukuya kwiFujirebio Diagnostics, Inc.