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FDA Ivomereza Kusankhidwa Kwapadera kwa Phunziro la Liquid Biopsy

Written by mkonzi

Kusankhidwa ndi kuvomera kumawonetsa zochitika zofunika kwambiri pakupititsa patsogolo njira yachipatala ya Insightec Blood Brain Barrier (BBB) ​​pogwiritsa ntchito Acoustic Therapy.  

Insightec lero yalengeza kuti yalandira chivomerezo cha FDA chopereka zida ziwiri zofunika kwambiri zofufuzira (IDE) pamakina ake a Exablate Neuro - imodzi ya khansa ya m'mapapo yopanda yaying'ono (NSCLC) yomwe yasokoneza ubongo molumikizana ndi chisamaliro chokhazikika. Keytruda®, ndi imodzi yopititsa patsogolo mphamvu ya biopsy yamadzimadzi pakuwunika mobwerezabwereza odwala omwe ali ndi khansa yaubongo. A FDA aperekanso dzina la "Breakthrough Device" pamankhwala a NSCLC, kuthandiza kufulumizitsa chitukuko chake ndikuwunikanso.

Insightec ikukonzekera kuyambitsa kafukufuku wa LIMITLESS (NSCLC) kuti awone phindu lachipatala pogwiritsa ntchito ultrasound yosasunthika, yotsika kwambiri komanso ya systemic immunotherapy pochiza odwala omwe ali ndi metastases muubongo kuchokera ku khansa ya m'mapapo. 

"Kugwiritsiridwa ntchito kwa low-intensity focused ultrasound (LIFU) ndi ma microbubbles kuti atsegule chotchinga cha ubongo wa magazi (BBB) ​​ndi chitukuko chosangalatsa cha neuro-oncology chomwe chimalonjeza kukhala kusintha kwachidziwitso kwa odwala omwe ali ndi zotupa muubongo," anati kuphunzira Principal Investigator Dr. Manmeet Ahluwalia, MD, MBA, Chief of Solid chotupa Medical Oncology, Wachiwiri Director ndi Chief Scientific Officer pa Miami Cancer Institute, mbali ya Baptist Health South Florida. "Kulumikizana kwapadera kwa LIFU BBB kutsegulira njira yoperekera mankhwala bwino, kutulutsidwa kwa neoantigen komanso kukulitsa chitetezo chamthupi ndizosintha zomwe zingatithandizire kukulitsa njira zamankhwala zomwe zilipo kwa odwalawa."

Liquid biopsy ndi njira yatsopano yopangira khansa yosasokoneza, kusankha chithandizo, kuyang'anira matenda otsalira, kuzindikira msanga omwe akuyankha motsutsana ndi omwe sayankha, ndikuwunika momwe chotupa chikuyendera motsutsana ndi pseudoprogression.

WTM London 2022 zidzachitika kuyambira 7-9 Novembala 2022. Lowetsani tsopano!

"Ngakhale kuti khansa ina yapita patsogolo kwambiri, kufufuza kwamadzimadzi kwakhalabe ndi zotsatira zochepa za zotupa za muubongo chifukwa cha kukhalapo kwa chotchinga cha ubongo cha magazi, chomwe chimalepheretsa kuzindikira zizindikiro m'magazi," anatero Dr. Achal Singh Achrol, MD, FAANS, Chief Medical Officer. wa Insightec. "Kafukufuku wam'mbuyomu komanso woyambirira wa anthu awonetsa kuti kutsika kwamphamvu kwa ultrasound (LIFU) kumatha kuwonjezera pang'onopang'ono kutsekeka kwa chotchinga muubongo wamagazi ndikulola kuti ma biomarker azidutswa apadera am'deralo apangitse biopsy yamadzi yosasokoneza mu zotupa za muubongo. Kuyesa kofunikira kumeneku kudzafufuza kwanthawi yoyamba za phindu lachipatala panjira imeneyi ngati njira ina yosinthira ma neurosurgical biopsies. ”

"Insightec ikupitirizabe kugwirizana ndi ofufuza otsogolera kuti apititse patsogolo kugwiritsa ntchito ma acoustic therapy mu ubongo," adatero Maurice R. Ferré, MD, Insightec CEO ndi Chairman wa Board. "Ntchitoyi ikuyang'ana pakutsegula bwino chotchinga muubongo wamagazi pogwiritsa ntchito mphamvu yocheperako komanso imatha kusintha njira zochizira komanso zozindikirira matenda ngati khansa ya muubongo. Cholinga chathu chachikulu ndi, monga nthawi zonse, kukhudza moyo wa odwala. ”

Chipangizo cha Exablate Neuro chavomerezedwa kale ndi FDA kuchiza matenda a Essential Tremor ndi Parkinson's Refractory. Kumapeto kwa 2021 kunali zipatala za 42 ku United States zogwiritsa ntchito chipangizo cha Insightec Exblate Neuro kuchiza odwala omwe ali ndi izi. Dongosolo la Insightec Exablate Prostate lalandira chilolezo cha FDA 510K chochotsa minyewa ya prostate yokhala ndi mphamvu yayikulu kwambiri ya Focused Ultrasound.

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mkonzi

Mkonzi wamkulu wa eTurboNew ndi Linda Hohnholz. Amakhala ku eTN HQ ku Honolulu, Hawaii.

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