Vivera Pharmaceuticals, Inc. uye diagnostic test distributor Areum Bio LLC nhasi yakazivisa kugadzwa kwechiteshi chekudyidzana kuwedzera Access Bio, Inc.'s CareStart™ COVID-19 yekukurumidza antigen bvunzo uye iyo FDA yekukurumidzira kushandiswa kwemvumo (EUA) chigadzirwa mutsetse Distribution) .Areum Bio yatove muparidzi mukuru weCareStart ™ COVID-19 inokurumidza antigen bvunzo kubva kuNew Jersey inogadzira Access Bio, uye ichatsvaga kusimbisa basa rayo rekupa cheni kuburikidza neVivera yakakura network yevanopa hutano nemasangano.
Semayunivhesiti, mabhizinesi, ndege, uye nzvimbo dzeveruzhinji dzinoshandisa kuyedza sechikamu chekudzokera-kuchikoro, basa, kufamba, uye zvibvumirano zvepati, kuwanikwa kwekuyedzwa kweCCIDID-19 kunoramba kuri chinhu chakakosha.Kushanda kweEUA-yakatenderwa Point-of-Care (POC) CareStart™ yekukurumidza antigen bvunzo, pamwe neiyo Vivera yakakura yekugovera kugona, ichaita kuti ive nyore kuwana nekukurumidza kuongororwa kwekuongorora mhinduro.
United States yakawana zvibodzwa zvikuru mukukunda pamusoro pedenda, asi nekuti huwandu hwekudzivirira huri pasi pemazinga akakodzera uye kutyisidzira kwemhando nyowani kuri kuramba kuchibuda pasirese, zvichiri kukosha kuti nyika irambe ichitevera COVID-19 bvunzo mapuroteni kuderedza kupararira .Kudyidzana kwekugovera pakati peVivera, Areum Bio uye Access Bio inofambisa kukurumidza kuyedzwa nekukurumidza sezvinobvira.Semugovera ane mvumo yeCareStart™ yekukurumidza antigen bvunzo, Vivera inotarisira kuwedzera kuvharika kwayo kuti ive nechokwadi chekuti varapi vehutano nevarwere vawana mukana wekuyedzwa nekukurumidza kubatsira kuchengetedza nharaunda yedu.
"Kubatana uku kunoratidza mubatanidzwa mutsva weVivera," akadaro Paul Edalat, Sachigaro uye CEO weVivera Pharmaceuticals."Kambani inokudzwa kushanda neAreum Bio uye Access Bio kuti ipe nekukurumidza uye yakavimbika EUA-yakatenderwa COVID-19 kuongororwa kumasangano edu ehutano nevarwere munyika yose.Nekuwedzera huwandu hwekuyedzwa, Vivera ichaona kuti vatinoshanda navo nevarwere, Kunyanya nharaunda dzakasiiwa dzinotsamira zvakanyanya kwatiri dzinogona kuwana mhedzisiro inoyerwa. "
"Uyu mukana wakanaka weAreum Bio wekudyidzana nekambani ine mukurumbira yemishonga yeVivera kugovera CareStart™ COVID-19 nekukurumidza antigen test munyika yose," akadaro Dr. Jong Kim, mutungamiri weAreum Bio.“Kuburikidza nemubatanidzwa uyu, tichishandisa chishuwo chedu nehunyanzvi, tichakwanisa kupa matipi ekuyedza anokurumidza uye akavimbika kunharaunda dzakatenderedza nyika nenguva uye inoshanda.Isu tinotenda kuti kunyangwe michina yekurapa ine hunyanzvi, Izvo zvakare hazvina kukosha kunze kwekunge zvagoverwa kuvarwere vanozvida.KuAreum Bio, isu tinotenda zvakasimba kuti tichabudirira chete kana zvigadzirwa zvedu zvitsva zvasvika kuvarwere nevapepi uye vozadzisa zvinangwa zvavo.Nokudaro, tinogara tichishanda nesimba., Kuendesa zvigadzirwa zvedu kune vatengi nekukurumidza uye nenzira inoshanda. "
Kuburikidza nekudyidzana kwavo kwehurongwa hwekugovera, Vivera, Areum Bio, uye Access Bio vanotarisira kutsigira nyika yakachengeteka uye isina musono kudzoka kune yakajairika nekuwedzera kuwanikwa kweyemhando yepamusoro yekukurumidza kuyedza munyika yose.
CareStart ™ COVID-19 Antigen Test is a lateral flow immunochromatographic bvunzo inoshandiswa kuona zvine hunhu nucleocapsid protein antigen kubva kuSARS-CoV-2 mune nasopharyngeal kana nasal swab samples inounganidzwa zvakananga kubva kune vanofungidzirwa Vanhu vane COVID-19 vanofungidzirwa kuti vane COVID-19 mupi wehutano anotora bvunzo mbiri mukati memazuva mashanu ekutanga ekutanga kwezviratidzo, kana kubva kune vanhu vasina zviratidzo kana zvimwe zvikonzero zvechirwere chechirwere, zvishoma maawa makumi maviri nemana pakati pekuedzwa Uye pasina anopfuura maawa makumi mana nemasere.
Kuongororwa kunogumira kumarabhoritari akasimbiswa pasi peClinical Laboratory Improvement Amendment (CLIA) ya1988, 42 USC §263a, uye marabhoritari aya anozadzikisa zvinodiwa pakuita bvunzo dzepakati nepakati, dzepamusoro, kana dzisina kusununguka.Muedzo uyu unotenderwa kushandiswa munzvimbo-yekutarisira (POC), kureva, munzvimbo dzekuchengeta varwere dzinoshandiswa pasi pezvitupa zveCLIA, zvitupa zvekuteerera, kana zvitupa.
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Areum Bio, LLC inovimbika kugovera mudziyo wezvokurapa uye yakagadzira kudyidzana kwakavimbika neAccess Bio, Inc. Areum Bio inhengo yeIvy Pharma Inc. ine dzimbahwe kuNew Jersey.Iyo kambani inoshandira pamwe nevakawanda bhizinesi vanobatana uye yakagadzira nzira dzekugovera pasi rese.Pamusoro penhoroondo yayo yemakore gumi neshanu yekugovera muUnited States, ine Kubatsira, Areum Bio yakakwirawo kubatsira kukurumidza kugovera yakavimbika coronavirus test kits kuburikidza netiweki yayo yakakura.Kambani yakazvipira kuenderera mberi nekusimudzira hutano hweveruzhinji uye kugara zvakanaka kwevanhu nekupa echokwadi uye akavimbika diagnostic test kits panguva yakakodzera.
Access Bio, Inc. inyanzvi yekuongorora chirwere inogadzira iri muNew Jersey, ichiri kutarisa nezvekutsvaga, kusimudzira uye kugadzirwa kwezvirwere zvinotapukira.Access Bio yakazvipira kudzivirira uye kutanga kuongororwa kwezvirwere zvinotapukira kuburikidza nekutsvagisa, kusimudzira uye kugadzira in vitro nekukurumidza diagnostic bvunzo, biosensors uye mamorekuru diagnostic zvigadzirwa.Zvichienderana nezvinodiwa zvikuru uye kugona kuita zvakanaka, kambani inoshandira pamwe nevamwe pasi rose, kusanganisira Bill and Melinda Gates Foundation, World Health Organisation, neUnited Nations Children's Fund.
Nguva yekutumira: Jul-01-2021