Sabuwar Gwaji don Inganta Ganewar Cutar Alzheimer

Hukumar Abinci da Magunguna ta Amurka a yau ta ba da izinin tallace-tallace don gwajin gwaji na farko a cikin vitro don ganowa da wuri na amyloid plaques masu alaƙa da cutar Alzheimer. Gwajin Lumipulse G β-Amyloid Ratio (1-42 / 1-40) an yi nufin amfani da shi a cikin manya marasa lafiya, masu shekaru 55 da haihuwa, suna gabatar da nakasar fahimi waɗanda ake kimanta cutar Alzheimer da sauran abubuwan da ke haifar da raguwar fahimi.           

"Samun gwajin gwajin in vitro wanda zai iya kawar da buƙatar gwajin PET mai cin lokaci da tsada labari ne mai girma ga mutane da iyalai da ke damuwa da yiwuwar gano cutar Alzheimer," in ji Jeff Shuren, MD, JD, darekta. na Cibiyar FDA don Na'urori da Lafiyar Radiyo. "Tare da gwajin Lumipulse, akwai wani sabon zaɓi wanda yawanci za'a iya kammala shi a rana ɗaya kuma zai iya ba wa likitoci bayanai iri ɗaya game da matsayin amyloid na kwakwalwa, ba tare da haɗarin radiation ba, don taimakawa wajen sanin ko rashin fahimtar majiyyaci ya kasance saboda cutar Alzheimer. ”

A cewar Cibiyar Kiwon Lafiya ta Ƙasa, fiye da Amirkawa miliyan shida, mafi yawan shekaru 65 ko tsufa, na iya samun ciwon hauka wanda cutar Alzheimer ta haifar, rashin lafiyar kwakwalwa da aka sani don lalata ƙwaƙwalwar ajiya da basirar tunani a hankali, kuma, ƙarshe, ikon aiwatar da aikin. ayyuka mafi sauƙi. A yawancin mutanen da ke fama da cutar Alzheimer, alamun asibiti suna fara bayyana daga baya a rayuwa. 

Cutar Alzheimer na ci gaba, ma'ana cewa cutar ta yi muni cikin lokaci. Farkon ganewar asali da daidai yana da mahimmanci don taimakawa marasa lafiya da masu kulawa tare da tsarawa da zaɓuɓɓukan magani na farko. Akwai buƙatar da ba a cika buƙata don ingantaccen gwaji mai aminci wanda zai iya gano daidaitattun marasa lafiya da allunan amyloid daidai da cutar Alzheimer. Yayin da amyloid plaques na iya faruwa a cikin wasu cututtuka, samun damar gano gaban plaque, tare da wasu kimantawa, yana taimaka wa likita don sanin dalilin da zai iya haifar da bayyanar cututtuka da binciken majiyyaci. Kafin izini na yau, likitoci sun yi amfani da positron emission tomography (PET), zaɓi mai yuwuwa mai tsada kuma mai wahala, don ganowa / ganin alamun amyloid a cikin kwakwalwar majiyyaci, sau da yawa shekaru kafin bayyanar asibiti ta fara, don taimakawa wajen gano cutar Alzheimer.

An yi nufin gwajin Lumipulse don auna ma'auni na β-amyloid 1-42 da β-amyloid 1-40 (takamaiman sunadaran da za su iya tarawa da kuma samar da plaques) abubuwan da aka samu a cikin ruwa na kashin baya na mutum (CSF), wanda zai iya taimakawa likitoci su tantance ko mai yiyuwa ne majiyyaci ya sami amyloid plaques, alamar cutar Alzheimer. Dole ne a fassara sakamakon tare da sauran bayanan asibiti na mara lafiya.

Kyakkyawan sakamakon gwajin Lumipulse G β-amyloid (1-42/1-40) ya yi daidai da kasancewar amyloid plaques, kama da abin da za a gani a cikin binciken PET. Sakamakon mummunan ya yi daidai da mummunan sakamakon amyloid PET scan. Sakamakon gwaji mara kyau yana rage yiwuwar rashin fahimtar majiyyaci saboda cutar Alzheimer, yana ba likitoci damar bin wasu abubuwan da ke haifar da raguwar fahimi da lalata. Ba a yi nufin gwajin a matsayin tantancewa ba ko gwajin ganowa kaɗai. Har ila yau, akwai yiwuwar za a iya ganin sakamakon gwaji mai kyau a cikin marasa lafiya da wasu nau'o'in yanayi na neurologic, da kuma a cikin tsofaffi masu lafiya masu lafiya, wanda ke nuna mahimmancin amfani da wannan gwajin tare da wasu ƙididdigar asibiti. 

FDA ta kimanta aminci da ingancin wannan gwajin a cikin binciken asibiti na samfuran CSF 292 daga bankin Samfurin Neuroimaging na Cutar Alzheimer. An gwada samfuran ta Lumipulse G β-amyloid Ratio (1-42 / 1-40) kuma idan aka kwatanta da sakamakon binciken amyloid PET. A cikin wannan binciken na asibiti, 97% na mutane tare da Lumipulse G β-amyloid Ratio (1-42/1-40) sakamako masu kyau sun sami kasancewar amyloid plaques ta PET scan kuma 84% na mutanen da ke da mummunan sakamako suna da mummunan amyloid PET scan. .

Hatsarin da ke da alaƙa da gwajin Lumipulse G β-amyloid (1-42/1-40) gwajin su ne galibi yuwuwar ingantaccen sakamako mara kyau na ƙarya. Sakamakon tabbatacce na ƙarya, tare da wasu bayanan asibiti, na iya haifar da rashin dacewa ga ganewar asali, da kuma rashin amfani da magani ga cutar Alzheimer. Wannan na iya haifar da baƙin ciki na tunani, jinkirin samun cikakkiyar ganewar asali da kuma kashe kuɗi da haɗarin illa daga jiyya maras buƙata. Sakamakon gwaji mara kyau na ƙarya zai iya haifar da ƙarin gwaje-gwajen bincike mara amfani da yuwuwar jinkiri a cikin ingantaccen magani. Mahimmanci, Lumipulse G β-amyloid Ratio (1-42 / 1-40) ba gwaji ba ne kawai kuma wasu ƙididdigar asibiti ko ƙarin gwaje-gwaje ya kamata a yi amfani da su don ƙayyade zaɓuɓɓukan magani. 

FDA ta sake nazarin na'urar ta hanyar De Novo premarket review, hanya mai tsari don ƙananan-zuwa matsakaici-matsakaicin na'urori na sabon nau'in. Wannan aikin ya ƙirƙiri sabon rarrabuwa na tsari, wanda ke nufin cewa na'urori masu zuwa na nau'in iri ɗaya tare da amfanin da aka yi niyya iri ɗaya na iya bi ta hanyar FDA ta 510 (k) tsarin premarket, ta yadda na'urori za su iya samun izinin tallace-tallace ta hanyar nuna daidaitattun daidaitattun na'urar.

Lumipulse G β-amyloid Ratio (1-42 / 1-40) an ba shi Breakthrough Device designation, tsarin da aka tsara don haɓaka haɓakawa da nazarin na'urorin da za su iya samar da magani mai mahimmanci ko ganewar cututtuka masu barazana ga rayuwa ko rashin iya jurewa. ko sharadi.

FDA ta ba da izinin tallace-tallace na Lumipulse G ß-Amyloid Ratio (1-42/1-40) zuwa Fujirebio Diagnostics, Inc.