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Seegene indleder eksport af sin seneste COVID-19-varianttest rundt om i verden for at hjælpe med at begrænse spredningen af pandemien
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Apr 16, 2021, 01:30 ET

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  • Seegene kan producere 300.000 variantdiagnostiske testkits, hvilket svarer til, at 30 millioner mennesker vil kunne blive testet hver måned.

SEOUL, Sydkorea, 16. april 2021 /PRNewswire/ -- Seegene Inc. (KQ 096530), en biotekvirksomhed med speciale i molekylær diagnostik, meddelte i dag, at virksomheden har sikret sig eksporttilladelse fra Sydkoreas ministerium for fødevare- og lægemiddelsikkerhed og nu kan indlede eksport af sine COVID-19-varianttest til lande verden over. Den førende biotekvirksomhed udtaler, at forsyningen af diagnostiske test til bestemmelse af coronavarianter vil forny den globale indsats i kampen mod pandemien, som nu forekommer med mere smitsomme og dødelige virusvarianter.

Seegenes seneste COVID-19-varianttest, 'AllplexTM SARS-CoV-2 Master Assay' og 'AllplexTM SARS-CoV-2 Variants I Assay', distribueres til over 20 lande rundt om i verden, inkl. de hårdest ramte europæiske lande, herunder Storbritannien, Italien, Tyskland og Frankrig, samt Chile. Begge de variantdiagnostiske test blev CE-IVD-mærket i marts.

Efter tidligere at have sikret omfattende faciliteter til masseproduktion udtaler Seegene, at virksomheden kan producere 300.000 variantdiagnostiske testkits. Dette svarer til, at 30 millioner mennesker vil kunne blive testet hver måned.

"Den variantdiagnostiske test vil lette byrden for medicinske fagfolk overalt i verden ved at muliggøre variantpåvisning blot med en enkel PCR-test. Dette vil give mulighed for en mere grundig infektionsforebyggende tilgang i håndteringen af pandemien", fortæller Dr. Jong-Yoon Chun, administrerende direktør for Seegene.

'AllplexTM SARS-CoV-2 Master Assay', verdens første variantdiagnostiske test, kan med en enkelt multiplex realtids-PCR-test påvise COVID-19 og screene for adskillige virusvarianter i én reaktion - og på under 2 timer. Varianttesten kan bl.a. påvise virusvarianterne B.1.1.7, B.1.351 og P.1. 'AllplexTM SARS-CoV-2 Master Assay' kan tillige anvendes sammen med 'AllplexTM RV Essential Assay', en ét-trins analyse til screening for i alt 17 targetvira associeret med luftvejsinfektioner.

'AllplexTM SARS-CoV-2 Variants I Assay' kan påvise og differentiere mutationer i varianter og kan desuden forhåndsscreene for mulige nye varianter og dermed give indsigt i yderligere variationer. Denne variantdiagnostiske test kan identificere mutationer i varianter, inklusive B.1.1.7, B.1.351, P.1 og B.1.525, ved anvendelse af mindst ti proprietære teknologier, herunder multiplex realtids-PCR-metoden mTOCETM, en banebrydende teknologi, som kun Seegene kan levere. Anvendelse af Seegenes oprindelige teknologi til endogen intern kontrol muliggør desuden den mindre invasive metode, spytprøvetagning, i den nyeste varianttest.

"Jeg håber, at alle mennesker rundt om i verden, ved hjælp af Seegenes COVID-19-variantdiagnostiske test kan vende tilbage til normale tilstande og et sundt liv" siger Dr. Chun. "Seegene vil fortsat nøje overvåge udviklingen af virusvarianter og levere yderligere varianttest for at hjælpe med at begrænse spredningen af virus og sætte en stopper for pandemien".

Den variant af coronavirus, der først blev identificeret i Storbritannien sidste år, har nu spredt sig til over 114 lande rundt om i verden og er blevet den mest almindelige stamme af COVID-19 i USA. Den såkaldte "britiske variant", også kendt som B.1.1.7., har vist sig ikke kun at være mere smitsom, men også mere dødelig, hvilket vækker bekymring verden over. B.1.351, en anden variant, som skaber bekymring, blev først opdaget i Sydafrika og har vist sig at reducere effektiviteten af visse vacciner. Dette fører til et stigende behov for hurtigere og mere nøjagtig diagnostik.

Om Seegene, Inc.

Seegene, Inc blev grundlagt i Seoul, Sydkorea, i 2000 med datterselskaber i USA, Canada, Tyskland, Italien, Mexico, Brasilien og Mellemøsten og er en in vitro-diagnostisk virksomhed (IVD), der har forvandlet koncepter til produkter gennem deres banebrydende aktiviteter inden for forskning og udvikling. Seegenes oprindelige patentteknologier ligger til grund for DPO™ (Dual Priming Oligonucleotide) til amplifikation af flere mål, TOCE™ til detektion af flere mål i en enkelt kanal, MuDT™, verdens første PCR-teknologi i realtid, der leverer individuelle Ct-værdier til flere mål i en enkelt kanal til kvantitative analyser, og mTOCE™, teknologi til detektion af multiplex-mutation. Ved at anvende disse banebrydende molekylære diagnostiske teknologier (MDx) på diagnostiske kits samt andre værktøjer har Seegene forbedret sensitiviteten og specificiteten af PCR (polymerasekædereaktion) til hidtil usete niveauer, hvilket giver multiplex-PCR-produkter, der targeterer og detekterer gener af flere patogener samtidigt og dermed sparer testtid og omkostninger. Seegene sætter fortsat nye standarder i MDx og leverer nye, omkostningseffektive innovationer.

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