Mayeso Atsopano Othandizira Kuzindikira Matenda a Alzheimer's

Bungwe la US Food and Drug Administration lero lalola kutsatsa kwa mayeso oyamba a in vitro kuti azindikire msanga zolembera za amyloid zomwe zimakhudzana ndi matenda a Alzheimer's. Mayeso a Lumipulse G β-Amyloid Ratio (1-42 / 1-40) amapangidwa kuti azigwiritsidwa ntchito kwa odwala akuluakulu, azaka za 55 kapena kuposerapo, omwe ali ndi vuto la kuzindikira omwe akuwunikiridwa chifukwa cha matenda a Alzheimer's ndi zomwe zimayambitsa kuchepa kwa chidziwitso.           

"Kupezeka kwa mayeso a in vitro diagnostic omwe atha kuthetsa kufunika kowononga nthawi komanso mtengo wa PET scans ndi nkhani yabwino kwa anthu ndi mabanja omwe akukhudzidwa ndi kuthekera kwa matenda a Alzheimer's," adatero Jeff Shuren, MD, JD, director. a FDA's Center for Devices and Radiological Health. "Ndi mayeso a Lumipulse, pali njira yatsopano yomwe imatha kutha tsiku lomwelo ndipo imatha kupatsa madokotala chidziwitso chofananira chokhudza ubongo wa amyloid, popanda chiwopsezo cha radiation, kuti athe kudziwa ngati vuto la kuzindikira kwa wodwala ndi chifukwa cha matenda a Alzheimer's. ”

Malinga ndi National Institutes of Health, aku America opitilira 65 miliyoni, ambiri azaka XNUMX kapena kupitilira apo, amatha kukhala ndi vuto la dementia chifukwa cha matenda a Alzheimer's, matenda aubongo omwe amadziwika kuti amawononga pang'onopang'ono kukumbukira ndi luso loganiza, ndipo, pamapeto pake, amatha kuchita masewera olimbitsa thupi. ntchito zosavuta. Mwa anthu ambiri omwe ali ndi matenda a Alzheimer's, zizindikiro zachipatala zimayamba kuonekera pambuyo pake. 

Matenda a Alzheimer amapita patsogolo, kutanthauza kuti matendawa amakula kwambiri pakapita nthawi. Kuzindikira koyambirira komanso kolondola ndikofunikira kuti athandize odwala ndi osamalira pokonzekera komanso njira zoyambira kulandira chithandizo. Pali kufunikira kosakwanira kwa mayeso odalirika komanso otetezeka omwe amatha kuzindikira molondola odwala omwe ali ndi zolembera za amyloid zomwe zimagwirizana ndi matenda a Alzheimer's. Ngakhale kuti zolembera za amyloid zimatha kuchitika m'matenda ena, kutha kuzindikira kukhalapo kwa zolembera, pamodzi ndi kuwunika kwina, kumathandiza dokotala kudziwa chomwe chimayambitsa zizindikiro ndi zomwe wodwalayo apeza. Asanavomerezedwe masiku ano, madokotala amagwiritsa ntchito positron emission tomography (PET) scans, njira yomwe ingakhale yokwera mtengo komanso yovuta, kuti azindikire / kuona zolembera za amyloid mu ubongo wa wodwala, nthawi zambiri zaka zambiri zizindikiro zachipatala zisanayambike, kuti athandize kuzindikira matenda a Alzheimer's.

Mayeso a Lumipulse amapangidwa kuti ayese chiŵerengero cha β-amyloid 1-42 ndi β-amyloid 1-40 (mapuloteni enieni omwe amatha kudziunjikira ndikupanga mapepala) omwe amapezeka mu ubongo wa msana (CSF), zomwe zingathandize madokotala kudziwa ngati wodwala akhoza kukhala ndi zolembera za amyloid, chizindikiro cha matenda a Alzheimer's. Zotsatira ziyenera kutanthauziridwa mogwirizana ndi chidziwitso chachipatala cha odwala.

Zotsatira zabwino za Lumipulse G β-amyloid Ratio (1-42 / 1-40) zimagwirizana ndi kukhalapo kwa zolembera za amyloid, zofanana ndi zomwe zingawoneke mu PET scan. Zotsatira zoyipa zimagwirizana ndi zotsatira zoyipa za amyloid PET scan. Zotsatira zoyipa zoyesa zimachepetsa mwayi woti kusokonezeka kwa chidziwitso kwa wodwala kumachitika chifukwa cha matenda a Alzheimer's, zomwe zimapangitsa kuti madokotala azitsatira zomwe zimayambitsa kuchepa kwa chidziwitso ndi dementia. Kuyesedwa sikunapangidwe ngati kuyesa kapena kuyesa kodziyimira pawokha. Palinso mwayi woti zotsatira zabwino zoyezetsa zitha kuwoneka mwa odwala omwe ali ndi mitundu ina ya neurologic, komanso anthu okalamba omwe ali ndi thanzi labwino, zomwe zimagogomezera kufunika kogwiritsa ntchito mayesowa limodzi ndi zowunikira zina zachipatala. 

A FDA adawunika chitetezo ndi mphamvu ya mayesowa mu kafukufuku wazachipatala wa zitsanzo 292 CSF kuchokera ku banki ya Alzheimer's Disease Neuroimaging Initiative. Zitsanzozo zinayesedwa ndi Lumipulse G β-amyloid Ratio (1-42 / 1-40) ndikuyerekeza ndi zotsatira za scan ya amyloid PET. Mu phunziro lachipatala ili, 97% ya anthu omwe ali ndi Lumipulse G β-amyloid Ratio (1-42 / 1-40) zotsatira zabwino anali ndi kupezeka kwa amyloid plaques ndi PET scan ndipo 84% ya anthu omwe anali ndi zotsatira zoipa anali ndi PET scan ya amyloid. .

Zowopsa zomwe zimayenderana ndi mayeso a Lumipulse G β-amyloid Ratio (1-42/1-40) makamaka kuthekera kwa zotsatira zabodza komanso zabodza. Zotsatira zabwino zabodza, mogwirizana ndi zidziwitso zina zachipatala, zingayambitse matenda osayenera, komanso chithandizo chosafunika cha matenda a Alzheimer's. Izi zingayambitse kupsinjika maganizo, kuchedwa kulandira matenda oyenerera komanso ndalama zomwe zingabweretse mavuto omwe amabwera chifukwa cha chithandizo chosafunikira. Zotsatira zabodza za mayeso olakwika zingapangitse mayeso owonjezera osafunikira komanso kuchedwa kwamankhwala othandizira. Chofunika kwambiri, Lumipulse G β-amyloid Ratio (1-42 / 1-40) siyeso yodziyimira yokha komanso kufufuza kwina kwachipatala kapena mayesero owonjezera ayenera kugwiritsidwa ntchito pofuna kudziwa njira zothandizira. 

A FDA adawunikiranso chipangizochi kudzera munjira yowunikiranso msika wa De Novo, njira yoyendetsera zida zotsika mpaka zochepera zamtundu watsopano. Izi zimapanga gulu latsopano loyang'anira, zomwe zikutanthauza kuti zida zotsatila zamtundu womwewo zomwe zimagwiritsidwa ntchito zomwezo zitha kudutsa mumsika wa 510(k) wa FDA, pomwe zida zitha kupeza chilolezo chotsatsa powonetsa kufanana kwakukulu ndi chipangizo cholozera.

Lumipulse G β-amyloid Ratio (1-42 / 1-40) inapatsidwa dzina la Breakthrough Device, njira yopangidwira kuti ifulumizitse chitukuko ndi kuwunikiranso zipangizo zomwe zingapereke chithandizo chamankhwala chothandizira kapena kuzindikira matenda owopsa kapena osachiritsika. kapena mikhalidwe.

A FDA adalola kutsatsa kwa Lumipulse G ß-Amyloid Ratio (1-42/1-40) kupita ku Fujirebio Diagnostics, Inc.