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Seegene præsenterer verdens første kommercielle "3 Ct" PCR-test
  • USA - English
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Seegene Inc.

May 01, 2022, 23:48 ET

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  • Giver Ct-værdier fra tre targets i én kanal; "3 Ct" PCR-test til lancering i første halvår af 2022
  • "Dream MDx-teknologi", der er udviklet på grundlag af Seegenes 20-årige ekspertise, kombinerer 19 forskellige patenterede teknologier, herunder DPO™, TOCE™ og MuDT™
  • "3 Ct" lægger fundamentet for automatiserede syndromiske tests og gør molekylær diagnostik (MDx) mere tilgængelig

SEOUL, Sydkorea, 2. maj 2022 /PRNewswire/ -- Seegene Inc. (KQ096530), Sydkoreas førende virksomhed inden for molekylær diagnostik (MDx), annoncerede i dag udviklingen af verdens første kommercielle PCR-test, der anvender "3 Ct"-teknologi. "Allplex™ HPV HR Detection" blev fremvist på 2022 European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), der blev afholdt den 23.-26. april i Lissabon i Portugal.

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[Figure 1] Seegene unveils world's first commercialized '3 Ct' PCR assay
[Figure 1] Seegene unveils world's first commercialized '3 Ct' PCR assay

I en polymerasekædereaktion (PCR) anvendes cyklustærskelværdien (Ct-værdien) til at kvantificere koncentrationen af en viral DNA-sekvens (target). På grund af teknologiske begrænsninger kan den konventionelle real-time PCR-teknik finde Ct-værdien af ét target i én kanal.

Men Seegenes "3 Ct"-teknologi kan angive Ct-værdien af tre targets i én kanal uden at gå på kompromis med følsomhed og specificitet. Den vellykkede udvikling er baseret på Seegenes 20-årige ekspertise og kombinerer 19 forskellige patenterede teknologier, herunder DPO™, TOCE™ og MuDT™. Ved hjælp af fem kanaler i et enkelt reagensrør kan Seegene levere kvantitative data for i alt 15 targets. "3 Ct" har fået tilnavnet "dream MDx-teknologien."

Seegene har planer om at anvende "3 Ct"-teknologi i hele deres produktserie, herunder tests for respiratoriske vira (RV), seksuelt overførte infektioner (STI), gastrointestinale infektioner (GI) og urinvejsinfektioner (UTI). Seegene forventer, at "3 Ct"-teknologien vil føre syndromisk testning op på et nyt niveau. Ved at påvise det sygdomsfremkaldende patogen, infektionsniveauet og potentialet for co-infektion vil det hjælpe med til at bestemme den rette behandling af patienterne. "3 Ct"-teknologien øger også testkapaciteten. De nye muligheder forventes at forbedre  service- og omkostningsstrukturen i den medicinske sektor, når "3 Ct"-teknologien bliver anvendt i vid udstrækning.

Allplex™ HPV HR Detection, der er Seegenes første produkt med anvendelse af "3 Ct"-teknologi, er udviklet til at kunne påvise 14 højrisikotyper af human papillomavirus (HPV), der kan forårsage livmoderhalskræft (se figur 1). Det angiver også den individuelle Ct-værdi for hver af disse typer, hvilket muliggør kvantitativ analyse, hvad angår infektionsniveauet. Tidlig påvisning af HPV bidrager til forebyggelse og håndtering af livmoderhalskræft. HPV-produkter fra andre brancheaktører leverer kun individuelle Ct-værdier for to højrisikotyper, HPV 16 og 18.

Allplex™  HPV HR Detection, der planlægges lanceret inden for første halvår af dette år, vil give en betydelig omkostningsfordel i forhold til eksisterende HPV-produkter og derved øge adgangen til PCR-tests, hvilket tidligere har været vanskeligt i visse lande på grund af de høje omkostninger. Produktet vil også være kompatibelt med Seegenes fuldautomatiske AIOS (All-In-One--System). Virksomheden har planer om at introducere branchens første "fuldautomatiske, syndromiske massetestsystem", som betyder, at der vil kunne udføres tests overalt, herunder på store hospitaler, C-laboratorier og endda små og mellemstore klinikker, så PCR-tests kan gøres til en del af hverdagen.

"HPV-genotypebestemmelse er afgørende for god patientopfølgning for at observere fremkomsten, persistensen eller clearing af hver genotype," siger HPV-ekspert Sebastien Hantz, professor ved det medicinske fakultet ved Université de Limoges i Frankrig. "Seegene er en virksomhed, der er meget involveret i udviklingen af molekylærdiagnostiske tests til påvisning af forskellige patogener. For visse kliniske situationer, som f.eks. ved luftvejsinfektioner, er syndromiske tests meget nyttige."

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