I-Vivera Pharmaceuticals, Inc. kanye nomsabalalisi wokuhlolwa kokuxilonga i-Areum Bio LLC namuhla imemezele ukusungulwa kobambiswano lwesiteshi ukuze kunwetshwe ukuhlolwa kwe-antigen ye-Access Bio, Inc. ye-CareStart™ COVID-19 esheshayo kanye nokugunyazwa kokusetshenziswa kwezimo eziphuthumayo kwe-FDA (EUA) komugqa womkhiqizo Wokusabalalisa) .I-Areum Bio isivele ingumsabalalisi oyinhloko wokuhlolwa kwe-CareStart™ COVID-19 okusheshayo kwe-antigen evela kumkhiqizi waseNew Jersey i-Access Bio, futhi izofuna ukuqinisa umsebenzi wayo wochungechunge lokuhlinzekwa kwempahla ngokusebenzisa inethiwekhi ebanzi ye-Vivera yabahlinzeki bezempilo nezinhlangano.
Njengoba amanyuvesi, amabhizinisi, izindiza, nezindawo zomphakathi zisebenzisa ukuhlola okuvamile njengengxenye yezivumelwano zabo zokubuyela esikoleni, umsebenzi, uhambo, nephathi, ukutholakala kokuhlolwa okuthembekile kwe-COVID-19 kuseyisidingo esiyinhloko.Ukusebenza kahle kokuhlolwa kwe-antigen egunyazwe yi-EUA-authorized Point-of-Care (POC) CareStart™, okuhambisana namandla amakhulu okusabalalisa e-Vivera, kuzoqinisekisa ukufinyelela okulula kuzixazululo zokuhlola zokuxilonga.
Izwe laseMelika selizuze ingqopha-mlando ekunqobeni ubhubhane, kodwa ngenxa yokuthi amazinga okugoma angaphansi kwamazinga afanele futhi usongo lokuhlukahluka okusha luyaqhubeka nokuvela emhlabeni wonke, kusabalulekile ukuthi izwe liqhubeke nokulandela imigomo yokuhlola i-COVID-19 ukuze ukunciphisa ukusabalala .Ukubambisana kokusabalalisa phakathi kwe-Vivera, i-Areum Bio kanye ne-Access Bio kuzokwenza lula ukuhlolwa okusheshayo ngokushesha ngangokunokwenzeka.Njengomsabalalisi ogunyaziwe wokuhlolwa kwe-antigen okusheshayo kwe-CareStart™, i-Vivera ihlose ukwandisa ukufakwa kwayo ukuze iqinisekise ukuthi abahlinzeki bezokunakekelwa kwempilo neziguli bayakwazi ukufinyelela ekuhlolweni okusheshayo ukusiza ukuqinisekisa ukuphepha komphakathi wethu.
"Lokhu kusebenzisana komkhiqizo kuphawula umfelandawonye wamasu amasha we-Vivera," kusho u-Paul Edalat, uSihlalo kanye ne-CEO ye-Vivera Pharmaceuticals.“Le nkampani ihlonishwa kakhulu ngokusebenzisana ne-Areum Bio kanye ne-Access Bio ukuhlinzeka ngokuhlolwa okugunyazwe yi-EUA okugunyazwe yi-COVID-19 ngokushesha nangokuthembekile ezinhlanganweni zethu zezempilo neziguli ezweni lonke.Ngokwandisa ububanzi bokuhlola, i-Vivera izoqinisekisa ukuthi ozakwethu kanye neziguli, Ikakhulukazi imiphakathi eyayincishwe amathuba ethembele kakhulu kithi ingathola imiphumela elinganisekayo.”
“Leli yithuba elihle kakhulu le-Areum Bio yokusebenzisana nenkampani ekhiqiza imithi ehlonishwayo i-Vivera ukusabalalisa ukuhlolwa kwe-CareStart™ COVID-19 okusheshayo kwe-antigen ezweni lonke,” kusho uDkt. Jong Kim, umongameli we-Areum Bio.“Ngalobu budlelwano, sisebenzisa uthando lwethu nobuchule obufanayo, sizokwazi ukuhlinzeka ngezinsiza zokuhlola ezisheshayo nezithembekile emiphakathini ezweni lonke ngesikhathi nangendlela ephumelelayo.Sikholelwa ukuthi ngisho nemishini yezokwelapha emisha kakhulu, Nayo ayinamsebenzi walutho ngaphandle uma isakazwa ezigulini ezizidingayo.Kwa-Areum Bio, sikholelwa ngokuqinile ukuthi sizophumelela kuphela lapho amadivaysi ethu amasha afinyelela iziguli nabahlinzeki futhi afinyelela imigomo yabo.Ngakho-ke, sihlala sisebenza kanzima., Ukuletha imikhiqizo yethu kumakhasimende ngendlela esheshayo nephumelelayo.”
Ngobudlelwano babo bokusabalalisa bamasu, i-Vivera, i-Areum Bio, ne-Access Bio inethemba lokusekela ukubuyela kwezwe okuphephile nokungenazihibe kokujwayelekile ngokwandisa ukutholakala kokuhlolwa okusheshayo kwekhwalithi ephezulu ezweni lonke.
I-CareStart™ COVID-19 Antigen Test ukuhlolwa kwe-lateral flow immunochromatographic esetshenziselwa ukuthola ngokufanelekile i-nucleocapsid protein antigen evela kwa-SARS-CoV-2 kuma-nasopharyngeal noma ama-nasal swab specimens aqoqwe ngokuqondile kubasolwa Abantu abane-COVID-19 basolwa nge-COVID-19 uma Umhlinzeki wezempilo uthatha izivivinyo ezimbili phakathi nezinsuku ezinhlanu zokuqala izimpawu, noma kubantu abangenazo izimpawu noma ezinye izizathu ze-epidemiological, okungenani amahora angu-24 phakathi kokuhlolwa Futhi amahora angaphezu kwama-48.
Ukuhlola kukhawulelwe kumalabhorethri agunyazwe ngaphansi kwe-Clinical Laboratory Improvement Amendment (CLIA) ka-1988, 42 USC §263a, futhi lezi labhorethri zihlangabezana nezimfuneko zokwenza ukuhlola okuyinkimbinkimbi okumaphakathi, okuphezulu, noma okukhululekile.Ukuhlolwa kugunyazwe ukuthi kusetshenziswe endaweni yokunakekela i-point-of-care (POC), okungukuthi, ezindaweni zokunakekela ezigulini ezisebenza ngaphansi kwezitifiketi zokukhululwa ze-CLIA, izitifiketi zokuthobela imithetho, noma izitifiketi zokuqinisekisa.
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I-Areum Bio, LLC isisabalalisi semishini yezokwelapha enokwethenjelwa futhi isungule ubambiswano oluthembekile ne-Access Bio, Inc. I-Areum Bio iyingxenye ye-Ivy Pharma Inc. enekomkhulu eNew Jersey.Inkampani ibambisana nabalingani abaningi bebhizinisi futhi isungule iziteshi zokusabalalisa emhlabeni wonke.Ngaphezu komlando wayo weminyaka eyi-15 wokusatshalaliswa e-United States, inokusiza, i-Areum Bio nayo yakhuphuka ukuze isize ngokushesha ukusabalalisa izinto ezithembekile zokuhlola i-coronavirus ngenethiwekhi yayo ebanzi.Inkampani izibophezele ngokuqhubekayo ukukhuthaza impilo yomphakathi nempilo yabantu ngokuhlinzeka ngezinsiza zokuhlola ezinembile nezithembekile ngesikhathi esifanele.
I-Access Bio, Inc. ingumkhiqizi wokuxilonga ohlonishwayo ose-New Jersey, osagxile ocwaningweni, ekuthuthukisweni nasekukhiqizweni kokuxilonga izifo ezithathelwanayo.I-Access Bio izibophezele ekuvimbeleni nasekuhlonzweni kusenesikhathi kwezifo ezithathelwanayo ngocwaningo, ukuthuthukiswa kanye nokukhiqizwa kwezivivinyo zokuxilonga ngokushesha ze-in vitro, ama-biosensor kanye nemikhiqizo yokuxilonga yamangqamuzana.Ngokusekelwe ezidingweni ezinkulu kanye namandla okwenza okuhle, inkampani ibambisana nozakwethu emhlabeni wonke, okuhlanganisa i-Bill and Melinda Gates Foundation, i-World Health Organization, kanye ne-United Nations Children's Fund.
Isikhathi sokuthumela: Jul-01-2021