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Amakhithi amathathu e-Epiprobe okuthola umdlavuza we-methylation athole isitifiketi se-EU CE

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NgoMeyi 8, 2022, i-Epiprobe yamemezela ukuthi yakha ngokuzimele amakhithi ayo okuhlonza i-methylation yomdlavuza ngokuzimela: TAGMe DNA Methylation Detection Kits (qPCR) for Cervical Cancer, TAGMe DNA Methylation Detection Kits (qPCR) for Endometrial Cancer, TAGMe DNA Methylation Detection Kits (qPCR) ) ye-Urothelial Cancer, bathole isitifiketi se-EU CE futhi bangathengiswa emazweni e-EU nasemazweni aqashelwa yi-CE.

Izimo eziphelele zokusetshenziswa kwekhithi yokutholwa kwe-DNA methylation emithathu
La makhithi amathathu angenhla ahambisana ngokuphelele nemishini ye-qPCR evamile emakethe.Azidingi ukwelashwa kwe-bisulfite, zenza inqubo yokuthola kalula futhi elula.Umaka we-methylation owodwa usebenza kuzo zonke izinhlobo zomdlavuza ezivamile.
Izimo zokufaka isicelo se-TAGMe DNA Methylation Detection Kits (qPCR) yomdlavuza womlomo wesibeletho okuhlanganisa:
● Ukuhlolelwa umdlavuza womlomo wesibeletho kwabesifazane abangaphezu kweminyaka engama-30 ubudala
● Ukuhlolwa kobungozi kwabesifazane abane-HPV
● Ukuxilongwa okusizayo kwe-cervical squamous cell carcinoma kanye ne-adenocarcinoma
● Ukuqapha ukuphindaphinda kwangemuva kokuhlinzwa komdlavuza womlomo wesibeletho

Izimo zokusetshenziswa kwe-TAGMe DNA Methylation Detection Kits (qPCR) ye-Endometrial Cancer kuhlanganise:
● Ukuhlolelwa umdlavuza we-endometrial phakathi kwabantu abasengozini enkulu
● Ukugcwalisa igebe ekuhlonzweni kwamangqamuzana omdlavuza we-endometrial
● Ukuqapha ukuphindaphinda kwangemva kokuhlinzwa komdlavuza we-endometrial

Izimo zokusetshenziswa kwe-TAGMe DNA Methylation Detection Kits (qPCR) ye-Urothelial Cancer okuhlanganisa:
● Ukuhlolwa komdlavuza we-urothelial phakathi kwabantu abasengozini enkulu
● Ukuhlolwa kwangaphambili kwe-cystoscopy yesiguli
● Ukuhlolwa kwemiphumela yokwelashwa kokuhlinzwa ezigulini ezinomdlavuza wesinye
● Ukuhlolwa kokwelashwa ngamakhemikhali ezigulini ezinomdlavuza wesinye
● Ukuqapha ukuphindaphinda kwangemva kokuhlinzwa komdlavuza we-urothelial

Inqubo ye-Epiprobe'globalization iqhubeka ngokushesha, futhi imikhiqizo isidlulile Isitifiketi se-CE se-European Union.

Njengamanje, i-Epiprobe isungule ithimba lokubhalisa lochwepheshe.

Ngaleso sikhathi, kuhlanganiswe nesidingo esisha sokuhlolwa kwezimpawu zomdlavuza we-pan-cancer kanye nokuxilongwa okuhambisanayo, i-Epiprobe iqhubekile nokuqhubekisela phambili ukunwetshwa kwesigaba somkhiqizo kanye nezindlela ezintsha ze-R&D.Njengoba amakhithi amathathu okuthola umdlavuza wofuzo lwe-methylation athole isitifiketi se-EU CE, okubonisa ukuthi le mikhiqizo ihambisana neziqondiso ezihlobene nemishini yezokwelapha ye-EU in vitro diagnostic reagent, futhi ingathengiswa emazweni angamalungu e-EU nasemazweni aqaphela isitifiketi se-EU CE.Lokhu kuzothuthukisa futhi umugqa womkhiqizo wenkampani womhlaba wonke, kuthuthukise ukuncintisana okuphelele, futhi kufezekise ukwakheka kwayo kwebhizinisi lomhlaba wonke.

UNksz Hua Lin, oyi-CEO ye-Epiprobe waphawula ukuthi:
Ngemizamo ehlangene yokubhaliswa kwenkampani, i-R&D, ukuphathwa kwekhwalithi, ukumaketha neminye iminyango, i-Epiprobe ithole isitifiketi se-EU CE semikhiqizo ehlonza umdlavuza womlomo wesibeletho, umdlavuza we-endometrial, nomdlavuza we-urothelial.Ngenxa yale mizamo, indawo yokuthengisa ye-Epiprobe inwetshiwe ku-European Union nasezifundeni ezihlobene, okuthatha isinyathelo esiqinile ekufezekiseni ukwakheka kokuthengiswa komhlaba wonke kwemikhiqizo yenkampani."I-Epiprobe izohlakulela ngokujulile imakethe yomhlaba wonke yokuhlola umdlavuza kusenesikhathi, futhi ithuthukise izimakethe zamazwe ngamazwe kanye neziteshi, incike ekuphathweni kwekhwalithi kanye nohlelo lokubhalisa, izindlela zokuphatha amalebhu ezihamba phambili emhlabeni kanye nobuchwepheshe bokutholwa kwe-methylation, kusetshenziswa ubuchwepheshe nemikhiqizo ethuthuke kakhulu ukusiza abantu bomhlaba. , kuzuzisa impilo yendawo yonke.

Mayelana ne-CE
Ukumakwa kwe-CE kusho uphawu oluhlanganisiwe lwesitifiketi somkhiqizo lwamazwe e-EU.Ukumakwa kwe-CE kukhombisa ukuthi imikhiqizo ihambisana nezidingo eziyisisekelo ezisungulwe yimithetho efanele yase-Europe kwezempilo, ukuphepha, ukuvikelwa kwemvelo kanye nokuvikelwa kwabathengi, futhi le mikhiqizo ingafinyelelwa ngokusemthethweni futhi isatshalaliswe emakethe eyodwa ye-EU.

Mayelana ne-Epiprobe
Yasungulwa ngo-2018, i-Epiprobe, njengomsekeli kanye nephayona lokuhlolwa komdlavuza we-pan-cancer kusenesikhathi, iyibhizinisi lobuchwepheshe obuphezulu eligxile ekuxilongweni kwamangqamuzana omdlavuza kanye nemboni yezokwelapha enembile.Yakha eqenjini eliphezulu lochwepheshe be-epigenetics kanye nokuqongelela okujulile kwezemfundo, i-Epiprobe ihlola umkhakha wokutholwa komdlavuza, iphakamisa umbono "wokugcina wonke umuntu ekude nomdlavuza," ukuzibophezela ekutholakaleni kusenesikhathi, ukuxilongwa kusenesikhathi kanye nokwelashwa komdlavuza kusenesikhathi, okuzokwenza ngcono. izinga lokusinda kweziguli ezinomdlavuza futhi lithuthukise impilo yabantu bonke.


Isikhathi sokuthumela: May-08-2022