I-Vivera Pharmaceuticals, Inc. kunye nomsasazi wovavanyo lokuxilonga i-Areum Bio LLC namhlanje ibhengeze ukusekwa kobambiswano lwejelo lokwandisa i-Access Bio, Inc.'s CareStart™ COVID-19 uvavanyo olukhawulezayo lwe-antigen kunye nogunyaziso losetyenziso olungxamisekileyo lwe-FDA (EUA) Ukuhanjiswa komgca wemveliso) .I-Areum Bio sele ingoyena msasazi ophambili weCareStart ™ COVID-19 uvavanyo lwe-antigen olukhawulezayo oluvela kumenzi weNew Jersey Access Bio, kwaye iya kufuna ukomeleza umsebenzi wayo wekhonkco lokubonelela ngenethiwekhi ebanzi yeVivera yababoneleli bezempilo kunye nemibutho.
Njengeeyunivesithi, amashishini, iinkampani zeenqwelo moya, kunye neendawo zikawonke-wonke zisebenzisa uvavanyo lwesiqhelo njengenxalenye yezivumelwano zabo zokubuyela esikolweni, umsebenzi, uhambo, kunye netheko, ukufumaneka kovavanyo oluthembekileyo lwe-COVID-19 kuseyinto ebalulekileyo.Ukusebenza kwe-EUA-egunyazisiweyo yePoint-of-Care (POC) CareStart™ uvavanyo lwe-antigen olukhawulezayo, oludityaniswa namandla osasazo olubanzi lwe-Vivera, kuya kuqinisekisa ukufikelela lula kwizisombululo zovavanyo lokuxilonga ngokukhawuleza.
I-United States iphumelele imida ephambili ekoyiseni incopho yobhubhane, kodwa ngenxa yokuba amazinga okugonya engaphantsi kwamanqanaba afanelekileyo kwaye isoyikiso sokwahluka okutsha siyaqhubeka nokuvela kwihlabathi liphela, kusabalulekile ukuba ilizwe liqhubeke nokulandela imigaqo yovavanyo ye-COVID-19 ukuze ukunciphisa ukusasazeka.Intsebenziswano yokusabalalisa phakathi kweVivera, i-Areum Bio kunye ne-Access Bio iya kuququzelela uvavanyo olukhawulezayo ngokukhawuleza.Njengomthengisi ogunyazisiweyo weCareStart™ uvavanyo olukhawulezayo lwe-antigen, i-Vivera ijonge ukwandisa ukhuseleko lwayo ukuze kuqinisekiswe ukuba ababoneleli bezempilo kunye nezigulana banokufikelela kuvavanyo olukhawulezileyo ukunceda ukuqinisekisa ukhuseleko loluntu lwethu.
"Le ntsebenziswano ye-branding ibonisa intsebenziswano entsha yeqhinga leVivera," utshilo uPaul Edalat, uSihlalo kunye ne-CEO yeVivera Pharmaceuticals.“Inkampani inelunda lokusebenza kunye ne-Areum Bio kunye ne-Access Bio ukubonelela ngokukhawuleza nangokuthembekileyo kwe-EUA-egunyazisiweyo yovavanyo lwe-COVID-19 kwimibutho yethu yezempilo kunye nezigulana kwilizwe liphela.Ngokwandisa umda wovavanyo, iVivera iya kuqinisekisa ukuba amaqabane ethu kunye nezigulana, Ngokukodwa iindawo zokuhlala ezihlelelekileyo ezixhomekeke kuthi zinokufikelela kwiziphumo ezinokulinganiswa. "
“Eli lithuba elihle kakhulu le-Areum Bio yokusebenzisana nenkampani ethengisa amayeza eVivera ukusasaza uvavanyo olukhawulezayo lwe-CareStart Covid-19 kwilizwe lonke,” utshilo uGqr. Jong Kim, umongameli we-Areum Bio.“Ngale ntsebenziswano, sisebenzisa ukuthanda kwethu kunye nobuchule obufanayo, siya kukwazi ukubonelela ngezixhobo zovavanyo ezikhawulezayo nezithembekileyo kuluntu kwilizwe liphela ngexesha nangendlela esebenzayo.Sikholelwa ukuba nezona zixhobo zonyango zintsha, nazo azinaxabiso ngaphandle kokuba zisasazwe kwizigulana ezizifunayo.Kwi-Areum Bio, sikholelwa ngokuqinisekileyo ukuba siya kuphumelela kuphela xa izixhobo zethu ezintsha zifikelela kwizigulane kunye nababoneleli kwaye bahlangabezane neenjongo zabo.Ngoko ke, sisoloko sisebenza nzima., Ukuhambisa iimveliso zethu kubathengi ngokukhawuleza nangendlela esebenzayo. "
Ngobudlelwane babo bokusabalalisa ngobuchule, i-Vivera, i-Areum Bio, kunye ne-Access Bio inethemba lokuxhasa ukubuyisela ilizwe elikhuselekileyo nelingenamthungo kwindawo eqhelekileyo ngokunyusa ukufumaneka komgangatho ophezulu wokuvavanya ngokukhawuleza kwilizwe lonke.
ICareStart™ COVID-19 Antigen Test luvavanyo lwe-lateral flow immunochromatographic olusetyenziselwa ukubona ngokufanelekileyo i-nucleocapsid protein antigen esuka kwi-SARS-CoV-2 kwi-nasopharyngeal okanye i-nasal swab specimens eziqokelelwe ngokuthe ngqo kubarhanelwa Abantu abane-COVID-19 bakrokrelwa ukuba bane-COVID-19 umboneleli wezempilo uthatha iimvavanyo ezimbini phakathi kweentsuku ezintlanu zokuqala kweempawu, okanye kubantu abangenazimpawu okanye ezinye izizathu ze-epidemiological, ubuncinane iiyure ze-24 phakathi kweemvavanyo Kwaye akukho ngaphezu kweeyure ze-48.
Uvavanyo lukhawulelwe kwiilabhoratri eziqinisekisiweyo phantsi kwe-Clinical Laboratory Improvement Amendment (CLIA) ye-1988, i-42 USC §263a, kwaye ezi lebhu zihlangabezana neemfuno zokwenza uvavanyo oluphakathi, oluphezulu, okanye oluxolelweyo.Uvavanyo lugunyaziswe ukuba lusetyenziswe kwindawo ye-point-of-care (POC), oko kukuthi, iindawo zokunakekelwa kwesigulane ezisebenza phantsi kwezatifikethi zokuxolelwa ze-CLIA, izatifikethi zokuthobela, okanye izatifikethi zesiqinisekiso.
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I-Areum Bio, LLC ngumthengisi othembekileyo wesixhobo sonyango kwaye useke intsebenziswano ethembekileyo kunye ne-Access Bio, Inc. I-Areum Bio yi-subsidiary ye-Ivy Pharma Inc. eseNew Jersey.Inkampani isebenzisana namaqabane amaninzi eshishini kwaye iseke amajelo osasazo kwihlabathi liphela.Ukongeza kwimbali yayo ye-15 yeminyaka yokusasazwa e-United States, kufuneka Uncede, i-Areum Bio iphinde yanyuka ukuze incede ngokukhawuleza ukusasaza iikiti zovavanyo oluthembekileyo lwe-coronavirus ngokusebenzisa inethiwekhi yayo ebanzi.Inkampani izibophelele ekuqhubeni phambili ukukhuthaza impilo yoluntu kunye nentlalontle yoluntu ngokubonelela ngezixhobo zovavanyo ezichanekileyo nezithembekileyo ngexesha elifanelekileyo.
I-Access Bio, Inc. ngumenzi woxilongo ohloniphekileyo obekwe eNew Jersey, usagxile kuphando, uphuhliso kunye nokuveliswa koxilongo lwezifo ezosulelayo.Ukufikelela kwi-Bio kuzibophelele ekuthinteleni nasekufunyanisweni kwangaphambili kwezifo ezosulelayo ngophando, uphuhliso kunye nokuveliswa kovavanyo lwe-in vitro olukhawulezileyo lokuxilonga, ii-biosensor kunye neemveliso zokuxilonga iimolekyuli.Ngokusekelwe kwiimfuno ezinkulu kunye namandla okwenza okulungileyo, inkampani isebenzisana namaqabane kwihlabathi jikelele, kuquka i-Bill kunye ne-Melinda Gates Foundation, i-World Health Organization, kunye ne-United Nations Children's Fund.
Ixesha lokuposa: Jul-01-2021