Ukuhlolwa Okusha Kokuthuthukisa Ukuxilongwa Kwesifo I-Alzheimer's

I-US Food and Drug Administration namuhla ivumele ukumakethwa kokuhlolwa kokuqala kokuxilongwa kwe-in vitro ukuze kutholwe kusenesikhathi ama-amyloid plaque ahlobene nesifo i-Alzheimer's. Ukuhlolwa kwe-Lumipulse G β-Amyloid Ratio (1-42/1-40) kuhloswe ukuthi kusetshenziswe ezigulini ezikhulile, ezineminyaka engama-55 nangaphezulu, ezethula ukukhubazeka kwengqondo ezihlolelwa isifo se-Alzheimer kanye nezinye izimbangela zokuncipha kwengqondo.           

"Ukutholakala kokuhlolwa kwe-in vitro diagnostic okungase kuqede isidingo sokuthatha isikhathi esiningi futhi ezibizayo ze-PET scan kuyizindaba ezinhle kubantu ngabanye nasemindenini ethintekayo mayelana nokwenzeka kokuxilongwa kwesifo i-Alzheimer," kusho uJeff Shuren, MD, JD, umqondisi. ye-FDA's Center for Devices and Radiological Health. “Ngokuhlolwa kwe-Lumipulse, kunenketho entsha engaqedwa ngosuku olufanayo futhi enganikeza odokotela ulwazi olufanayo mayelana nesimo se-brain amyloid, ngaphandle kwengozi yemisebe, ukusiza ukunquma ukuthi ukukhubazeka kwengqondo yesiguli kungenxa yesifo i-Alzheimer's. ”

NgokweNational Institutes of Health, abantu baseMelika abangaphezu kwezigidi eziyisithupha, iningi labo elineminyaka engu-65 noma ngaphezulu, bangase babe nokuwohloka komqondo okubangelwa isifo i-Alzheimer’s, isifo sobuchopho esaziwa ngokucekela phansi inkumbulo nokucabanga kancane kancane, futhi, ekugcineni, nekhono imisebenzi elula kakhulu. Kubantu abaningi abanesifo i-Alzheimer's, izimpawu zomtholampilo ziqala ukuvela kamuva ekuphileni. 

Isifo i-Alzheimer's siyathuthuka, okusho ukuthi lesi sifo siba sibi kakhulu ngokuhamba kwesikhathi. Ukuxilongwa kusenesikhathi nokunembile kubalulekile ukusiza iziguli kanye nabanakekeli ngokuhlela kanye nezindlela zokwelashwa kusenesikhathi. Kunesidingo esingafinyeleleki sokuhlolwa okuthembekile nokuphephile okungakhomba ngokunembile iziguli ezinama-amyloid plaques ahambisana nesifo i-Alzheimer's. Nakuba ama-amyloid plaque engenzeka kwezinye izifo, ukukwazi ukubona ubukhona be-plaque, kanye nokunye ukuhlola, kusiza udokotela ukuba anqume imbangela engenzeka yezimpawu zesiguli kanye nokutholwe. Ngaphambi kokugunyazwa kwanamuhla, odokotela basebenzisa izikena ze-positron emission tomography (PET), inketho ebiza kakhulu futhi enzima, ukuthola/ukubona ngeso lengqondo ama-amyloid plaques ebuchosheni besiguli, ngokuvamile iminyaka ngaphambi kokuqala kwezimpawu zomtholampilo, ukusiza ekuxilongeni isifo i-Alzheimer's.

Ukuhlolwa kwe-Lumipulse kuhloswe ukukala isilinganiso se-β-amyloid 1-42 kanye ne-β-amyloid 1-40 (amaprotheni athile anganqwabelana futhi akhe ama-plaque) okugxilwe okutholakala oketshezini lomgogodla womuntu (CSF), olungasiza odokotela banqume ukuthi isiguli cishe sibe nama-amyloid plaque, uphawu oluphawulekayo lwesifo i-Alzheimer's. Imiphumela kufanele ihunyushwe ngokuhambisana nolunye ulwazi lomtholampilo lwesiguli.

Umphumela wokuhlola we-Lumipulse G β-amyloid Ratio (1-42/1-40) uhambisana nokuba khona kwama-amyloid plaque, afana nalokho okungabonwa ku-PET scan. Umphumela ongemuhle uhambisana nomphumela we-PET scan ongemuhle we-amyloid. Umphumela wokuhlolwa ongemuhle wehlisa amathuba okuthi ukukhubazeka kwengqondo kwesiguli kungenxa yesifo i-Alzheimer, okwenza odokotela baphishekele ezinye izimbangela zokuncipha kwengqondo kanye nokuwohloka komqondo. Ukuhlola akuhlosiwe njengokuhlola noma ukuhlolwa kokuxilonga okuzimele. Kukhona futhi ukuthi kungenzeka ukuthi umphumela wokuhlola omuhle ungabonakala ezigulini ezinezinye izinhlobo zezimo ze-neurologic, kanye nakubantu abadala abaphile kahle ngokwengqondo, okugcizelela ukubaluleka kokusebenzisa lolu hlolo ngokuhambisana nokunye ukuhlola komtholampilo. 

I-FDA ihlole ukuphepha nokusebenza kwalokhu kuhlolwa ocwaningweni lomtholampilo lwamasampuli angama-292 CSF avela ebhange eliyisampula le-Alzheimer's Disease Neuroimaging Initiative. Amasampula ahlolwe yi-Lumipulse G β-amyloid Ratio (1-42/1-40) futhi aqhathaniswa nemiphumela ye-amyloid PET scan. Kulolu cwaningo lomtholampilo, i-97% yabantu abane-Lumipulse G β-amyloid Ratio (1-42/1-40) imiphumela emihle babe nokuba khona kwama-amyloid plaque nge-PET scan kanti u-84% wabantu abanemiphumela engemihle babe ne-PET scan engalungile ye-amyloid. .

Izingozi ezihlobene nokuhlolwa kwe-Lumipulse G β-amyloid Ratio (1-42/1-40) ikakhulukazi amathuba okuba kube khona imiphumela yokuhlolwa okungelona iqiniso kanye nenegethivu engamanga. Imiphumela emihle engamanga, ngokuhlangana nolunye ulwazi lomtholampilo, ingaholela ekuxilongweni okungafanele, kanye nokwelashwa okungadingekile kwesifo i-Alzheimer's. Lokhu kungaholela ekucindezelekeni kwengqondo, ukubambezeleka ekutholeni ukuxilongwa okufanele kanye nezindleko kanye nengozi yemiphumela engemihle yokwelashwa okungadingekile. Imiphumela yokuhlolwa engemihle engamanga ingase ibangele ukuhlolwa okwengeziwe okungadingekile kokuxilonga kanye nokubambezeleka okungaba khona ekwelashweni okuphumelelayo. Okubalulekile, i-Lumipulse G β-amyloid Ratio (1-42/1-40) ayikona ukuhlolwa okuzimele futhi okunye ukuhlolwa komtholampilo noma ukuhlolwa okwengeziwe kufanele kusetshenziselwe ukunquma izinketho zokwelapha. 

I-FDA ibuyekeze idivayisi ngokusebenzisa indlela yokubuyekeza imakethe ye-De Novo, indlela yokulawula yamadivayisi anobungozi obuncane ukuya kobumaphakathi bohlobo olusha. Lesi senzo sidala isigaba esisha sokulawula, okusho ukuthi amadivayisi alandelayo ohlobo olufanayo anokusetshenziswa okufanayo okuhlosiwe angase adlule kunqubo ye-FDA's 510(k) yemakethe yangaphambili, lapho amadivayisi angathola ukugunyazwa kokumaketha ngokubonisa ukulingana okukhulu kudivayisi yesilandiso.

I-Lumipulse G β-amyloid Ratio (1-42/1-40) yanikezwa ukuqokwa kwe-Breakthrough Device, inqubo eklanyelwe ukusheshisa ukuthuthukiswa nokubuyekezwa kwamadivayisi angase ahlinzekele ukwelashwa okuphumelelayo noma ukuxilongwa kwezifo ezisongela ukuphila noma eziqeda amandla ngokungenakulungiseka. noma izimo.

I-FDA igunyaze ukumaketha kwe-Lumipulse G ß-Amyloid Ratio (1-42/1-40) kuya ku-Fujirebio Diagnostics, Inc.