I-FDA Igunyaza Ukuqokwa Okuthuthukile Kwesifundo Se-Liquid Biopsy

A BAMBA MahhalaRelease 4 | eTurboNews | eTN
Isithombe sikaLinda Hohnholz
Ibhalwe ngu Linda Hohnholz

Ukuqokwa nokugunyazwa kuphawula ingqopha-mlando ekuthuthukiseni umgwaqo womtholampilo we-Insightec Blood Brain Barrier (BBB) ​​kusetshenziswa i-Acoustic Therapy.  

I-Insightec namuhla imemezele ukuthi isithole imvume ye-FDA yokukhululwa okubili okubalulekile kwedivayisi yophenyo (IDE) ngohlelo lwayo lwe-Exablate Neuro - olulodwa lomdlavuza wamaphaphu ongewona omncane wamangqamuzana (NSCLC) osuqhamuke ebuchosheni ngokubambisana nokunakekelwa okujwayelekile. I-Keytruda®, kanye neyodwa yokuphumelela okuthuthukisiwe kwe-liquid biopsy yokuqapha ukuphinda kweziguli ezinomdlavuza oyinhloko wobuchopho. I-FDA iphinde yanikeza igama elithi "Breakthrough Device" lokwelashwa kwe-NSCLC, okusiza ukusheshisa ukuthuthukiswa nokubuyekezwa kwayo.

I-Insightec ihlela ukwethula ucwaningo oluthi LIMITLESS (NSCLC) ukuze kuhlolwe inzuzo yomtholampilo yokusebenzisa i-ultrasound egxilile engahlaliseki, egxile kancane ehlanganiswe ne-systemic immunotherapy ekwelapheni iziguli ezinemetastase yobuchopho evela kumdlavuza wamaphaphu. 

"Ukusetshenziswa kwe-low-intensity focused ultrasound (LIFU) enama-microbubbles ukuvula umgoqo wobuchopho begazi (BBB) ​​kuyinqubekelaphambili ejabulisayo ku-neuro-oncology enesithembiso sokuba ushintsho lwepharadigm ekwelapheni iziguli ezinezicubu zobuchopho," kusho ucwaningo Umphenyi Oyinhloko uDkt. Manmeet Ahluwalia, MD, MBA, Chief of Solid Tumor Medical Oncology, iPhini Lomqondisi kanye neChief Scientific Officer eMiami Cancer Institute, ingxenye yeBaptist Health South Florida. "I-synergy eyingqayizivele yokuvulwa kwe-LIFU BBB yokulethwa kwezidakamizwa okuthuthukisiwe, ukukhululwa kwe-neoantigen kanye nokuvuselelwa komzimba kungashintsha umdlalo emkhakheni wethu okuzosisiza sakhele izindlela zokwelapha ezitholakalayo zalezi ziguli."

I-Liquid biopsy iyindlela entsha ye-subtyping yomdlavuza engavamisile, ukukhetha ukwelashwa, ukuqapha isifo esisele, ukuhlonzwa kusenesikhathi kwabaphenduli bezokwelapha uma kuqhathaniswa nabangaphenduli, kanye nokuhlolwa kokuqhubeka kwesimila kuqhathaniswa ne-pseudoprogression.

"Naphezu kwenqubekelaphambili ephawulekayo kwamanye ama-cancer, i-biopsy ye-liquid ibe nempumelelo elinganiselwe ezimila zobuchopho ngenxa yokuba khona kwesithiyo sobuchopho begazi, esikhawulela ukubonwa kwesignali egazini," kusho uDkt. Achal Singh Achrol, MD, FAANS, Isikhulu Esiyinhloko Sezokwelapha. ye-Insightec. “Ucwaningo lwangaphambi komtholampilo kanye nolwasekuqaleni kwabantu lubonise ukuthi i-low-intensity focused ultrasound (LIFU) ingakhuphula isikhashana ukungeneka kwesithiyo sobuchopho begazi futhi ivumele ukudlula kwezimpawu zezinto eziphilayo eziqondene nesifunda ukuze zinike amandla i-biopsy yoketshezi engavamisile ezimila zobuchopho. Lesi sivivinyo somtholampilo esibalulekile sizophenya okokuqala ngqa ngenzuzo yomtholampilo kule ndlela njengenye indlela entsha ye-neurosurgical biopsies ehlaselayo. "

"I-Insightec iyaqhubeka nokusebenzisana nabacwaningi abahamba phambili ukuze kuthuthukiswe ukusetshenziswa kwe-acoustic therapy ebuchosheni," kusho uMaurice R. Ferré, MD, i-CEO ye-Insightec kanye noSihlalo weBhodi. "Lo msebenzi ugxile ekuvuleni ngokuphephile umgoqo wobuchopho begazi usebenzisa amandla aphansi we-acoustic futhi unamandla okuguqula izindlela zamanje zokwelapha kanye nokuxilonga izimo ezinjengomdlavuza wobuchopho. Umgomo wethu omkhulu, njengenjwayelo, uwukuba nomthelela omuhle ezimpilweni zeziguli.”

Umshini we-Exablate Neuro usuvele ugunyazwe i-FDA ukuze ulashwe i-Essential Tremor ne-Parkinson's Refractory Refractory. Ekupheleni kuka-2021 kwakunezikhungo zezokwelapha ezingu-42 e-United States ezisebenzisa idivayisi ye-Insightec Exblate Neuro ukwelapha iziguli ezinalezi zimo. Uhlelo lwe-Insightec Exablate Prostate luthole imvume ye-FDA 510K yokunqamula izicubu ze-prostate ezinomfutho ophezulu we-Focused Ultrasound.

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Isithombe sikaLinda Hohnholz

Linda Hohnholz

Umhleli omkhulu we eTurboNews ezinze eTN HQ.

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