Awọn ipinfunni Ounjẹ ati Oògùn AMẸRIKA loni yọọda tita ọja fun idanwo iwadii aisan in vitro akọkọ fun wiwa ni kutukutu ti awọn plaques amyloid ti o ni nkan ṣe pẹlu arun Alṣheimer. Idanwo Lumipulse G β-Amyloid Ratio (1-42 / 1-40) jẹ ipinnu lati lo ninu awọn alaisan agbalagba, ti ọjọ ori 55 ọdun ati agbalagba, ti n ṣafihan pẹlu ailagbara oye ti a ṣe ayẹwo fun arun Alzheimer ati awọn idi miiran ti idinku imọ.
"Wiwa ti idanwo iwadii in vitro ti o le ṣe imukuro iwulo fun akoko-n gba ati awọn iwoye PET gbowolori jẹ iroyin nla fun awọn eniyan kọọkan ati awọn idile ti o nii ṣe pẹlu iṣeeṣe ti iwadii aisan Alzheimer,” Jeff Shuren, MD, JD, oludari sọ. ti Ile-iṣẹ FDA fun Awọn Ẹrọ ati Ilera Radiological. “Pẹlu idanwo Lumipulse, aṣayan tuntun wa ti o le pari ni igbagbogbo ni ọjọ kanna ati pe o le fun awọn dokita alaye kanna nipa ipo amyloid ọpọlọ, laisi eewu itankalẹ, lati ṣe iranlọwọ lati pinnu boya ailagbara oye alaisan kan jẹ nitori arun Alzheimer. ”
Gẹgẹbi Awọn ile-iṣẹ Ilera ti Orilẹ-ede, diẹ sii ju miliọnu mẹfa Amẹrika, julọ ti ọjọ-ori 65 tabi agbalagba, le ni iyawere ti o fa nipasẹ arun Alṣheimer, rudurudu ọpọlọ ti a mọ lati pa iranti ati awọn ọgbọn ironu run laiyara, ati, nikẹhin, agbara lati gbe jade. alinisoro awọn iṣẹ-ṣiṣe. Ni ọpọlọpọ awọn eniyan ti o ni arun Alzheimer, awọn aami aisan ile-iwosan akọkọ han nigbamii ni igbesi aye.
Arun Alzheimer n tẹsiwaju, ti o tumọ si pe arun na n buru si ni akoko pupọ. Ibẹrẹ ati ayẹwo deede jẹ pataki lati ṣe iranlọwọ fun awọn alaisan ati awọn alabojuto pẹlu eto ati awọn aṣayan itọju tete. Iwulo ainidi wa fun idanwo igbẹkẹle ati ailewu ti o le ṣe idanimọ deede awọn alaisan ti o ni awọn ami-ami amyloid ni ibamu pẹlu arun Alṣheimer. Lakoko ti amyloid plaques le waye ni awọn arun miiran, ni anfani lati rii wiwa ti okuta iranti, pẹlu awọn igbelewọn miiran, ṣe iranlọwọ fun dokita lati pinnu idi ti o ṣeeṣe ti awọn ami aisan ati awọn awari alaisan. Ṣaaju si aṣẹ oni, awọn dokita ti lo awọn ọlọjẹ positron emission tomography (PET), aṣayan ti o ni iye owo ti o ni agbara pupọ, lati ṣe awari/aworan awọn plaques amyloid ninu ọpọlọ alaisan, nigbagbogbo awọn ọdun ṣaaju ibẹrẹ aami aisan ile-iwosan, lati ṣe iranlọwọ ni ṣiṣe iwadii aisan Alzheimer.
Idanwo Lumipulse ni a pinnu lati wiwọn ipin ti β-amyloid 1-42 ati β-amyloid 1-40 (awọn ọlọjẹ kan pato ti o le ṣajọpọ ati ṣe apẹrẹ awọn okuta iranti) awọn ifọkansi ti a rii ni omi-ọpa ẹhin ara eniyan (CSF), eyiti o le ṣe iranlọwọ fun awọn dokita pinnu boya boya O ṣeeṣe ki alaisan ni awọn ami amyloid plaques, ami pataki ti arun Alzheimer. Awọn abajade gbọdọ jẹ itumọ ni apapo pẹlu alaye ile-iwosan alaisan miiran.
Abajade idanwo Lumipulse G β-amyloid rere (1-42/1-40) jẹ ibamu pẹlu wiwa awọn ami amyloid, iru si ohun ti yoo rii ni ọlọjẹ PET kan. Abajade odi ni ibamu pẹlu abajade ọlọjẹ amyloid PET odi. Abajade idanwo odi dinku o ṣeeṣe pe ailagbara oye ti alaisan kan jẹ nitori arun Alṣheimer, ti o jẹ ki awọn oniwosan le lepa awọn idi miiran ti idinku imọ ati iyawere. Idanwo naa ko ni ipinnu bi ibojuwo tabi idanwo idanimọ-iduro nikan. O tun ṣee ṣe pe abajade idanwo rere ni a le rii ni awọn alaisan ti o ni awọn iru miiran ti awọn ipo neurologic, ati ni awọn eniyan ti o ni ilera ti ogbo, eyiti o tẹnumọ pataki ti lilo idanwo yii ni apapo pẹlu awọn igbelewọn ile-iwosan miiran.
FDA ṣe iṣiro aabo ati imunadoko idanwo yii ni iwadii ile-iwosan ti awọn ayẹwo CSF 292 lati banki ayẹwo Arun Neuroimaging Arun Alzheimer. Awọn ayẹwo naa ni idanwo nipasẹ Lumipulse G β-amyloid Ratio (1-42/1-40) ati ni afiwe pẹlu awọn abajade ọlọjẹ amyloid PET. Ninu iwadi ile-iwosan yii, 97% ti awọn ẹni-kọọkan pẹlu Lumipulse G β-amyloid Ratio (1-42/1-40) awọn abajade to dara ni wiwa awọn ami amyloid nipasẹ ọlọjẹ PET ati 84% ti awọn ẹni-kọọkan pẹlu awọn abajade odi ni ọlọjẹ amyloid PET ti ko dara. .
Awọn eewu ti o nii ṣe pẹlu Lumipulse G β-amyloid Ratio (1-42/1-40) idanwo jẹ iṣeeṣe ti rere eke ati awọn abajade idanwo odi eke. Awọn abajade rere eke, ni apapo pẹlu alaye ile-iwosan miiran, le ja si iwadii aisan ti ko yẹ ti, ati itọju ti ko wulo fun, Arun Alzheimer. Eyi le ja si aibalẹ ọkan, idaduro ni gbigba ayẹwo ti o pe daradara bi inawo ati eewu fun awọn ipa ẹgbẹ lati itọju ti ko wulo. Awọn abajade idanwo odi eke le ja si ni afikun awọn idanwo iwadii ti ko wulo ati idaduro agbara ni itọju to munadoko. Ni pataki, Lumipulse G β-amyloid Ratio (1-42 / 1-40) kii ṣe idanwo imurasilẹ ati awọn igbelewọn ile-iwosan miiran tabi awọn idanwo afikun yẹ ki o lo fun ṣiṣe ipinnu awọn aṣayan itọju.
FDA ṣe atunyẹwo ẹrọ naa nipasẹ ọna atunyẹwo premarket De Novo, ipa ọna ilana fun awọn ẹrọ kekere-si iwọntunwọnsi ti iru tuntun kan. Iṣe yii ṣẹda isọdi ilana tuntun, eyiti o tumọ si pe awọn ẹrọ atẹle ti iru kanna pẹlu lilo ipinnu kanna le lọ nipasẹ ilana iṣaaju ti FDA's 510 (k), eyiti awọn ẹrọ le gba aṣẹ titaja nipasẹ iṣafihan isọgba deede si ẹrọ asọtẹlẹ kan.
Iwọn Lumipulse G β-amyloid (1-42 / 1-40) ni a fun ni iyasọtọ ẹrọ Breakthrough, ilana ti a ṣe lati mu idagbasoke ati atunyẹwo awọn ẹrọ ti o le pese fun itọju ti o munadoko diẹ sii tabi iwadii aisan ti eewu-aye tabi awọn aarun alailagbara ti ko yipada. tabi awọn ipo.
FDA yọọda titaja ti Lumipulse G ß-Amyloid Ratio (1-42/1-40) si Fujirebio Diagnostics, Inc.
OHUN TO MU KURO NINU AKOKO YI:
- The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 (specific proteins that can accumulate and form plaques) concentrations found in human cerebral spinal fluid (CSF), which can help physicians determine whether a patient is likely to have amyloid plaques, a hallmark sign of Alzheimer’s disease.
- “With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease.
- There is also the possibility that a positive test result could be seen in patients with other types of neurologic conditions, as well as in older cognitively healthy people, which underscores the importance of using this test in conjunction with other clinical evaluations.
