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Obtained CE-IVD marking for Allplex™ Genital ulcer Assay and Allplex™ Candidiasis Assay
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Allplex™ Genital ulcer Assay and Allplex™ Candidiasis Assay. Allplex™ Genital ulcer Assay detects 7 pathogens (HSV1, HSV2, CMV, VZV, LGV related CMV, T. pallidum, H. ducreyi ) causing genital ulcer simultaneously. Allplex™ Candidiasis Assay detects and differentiate 7 candida spp.(C. albicans, C. glabrata, C. tropicalis, C. parapsilosis, C. krusei, C. lusitaniae, C. dubliniensis ) causing candidiasis simultaneously. Based on Seegene’s proprietary MuDT™ technology, this assay makes it possible to report multiple Ct values of each pathogen in a single channel using real-time PCR instruments.The CE mark will allow more opportunities for Seegene to market and sell within the European Union.
Oct 14, 2016｜ Allplex™ Genital ulcer Assay , Allplex™ Candidiasis Assay
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Obtained approval of MFDS for Allplex™ Respiratory Panel1
Allplex™ Respiratory Panel 1 has received approval from Korean Ministry of Food and Drug Safety (MFDS). This assay is a One-step real-time RT-PCR assay to detect simultaneously Flu A, Flu B, RSV A and RSV B with Flu A subtyping in a single tube, which enables appropriate antiviral drug treatments
Sep 01, 2016｜ Allplex™ Respiratory Panel 1
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Launched Allplex™ STI Essential Assay
Allplex™ STI Essential Assay is a multiplex real-time PCR test that can simultaneously detect seven of the more common causes of STIs from a wide range of specimen types including genital swab, urine and liquid based cytology specimen. The Allplex™ STI Essential Assay will provide clinicians with a powerful tool to help protect health and prevent the spread of STIs.
May 01, 2016｜ Allplex™ STI Essential Assay
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Seegene’s HPV DNA assay proves its excellent performance in WHO global HPV LabNet study.
Seegene’s HPV DNA assay showed superior performance at the World Health Organization (WHO) HPV Laboratory Network (HPV LabNet) global proficiency study. Cervical cancer is the third most common cancer among women worldwide, with human papillomavirus (HPV) infection linked to more than 99% of cervical cancers1). An accurate and internationally comparable HPV DNA detection and genotyping methodology is essential for investigating the baseline of HPV prevalence. However, HPV DNA test used today differ in their analytical performance with regard to type-specific sensitivity and specificity. Use of qualified proficient laboratory assay methods and qualified performance will ensure generating reliable data to support decision-making on HPV DNA test2). The WHO HPV LabNet has developed an international proficiency panel for HPV DNA detection and genotyping, and organized annual proficiency studies since 2008. It has been implemented study for HPV assays used in various laboratories, and in recent studies, total 119 laboratories participated in this study (2014 WHO HPV LabNet - Europe: 68 labs, Western Pacific: 25 labs, America: 14 labs, South East Asia: 8 labs, Africa: 3 labs, and Mediterranean: 1 lab). In the result of 2014 WHO HPV LabNet proficiency study, Seegene’s HPV DNA assay (Anyplex™ II HPV28 Detection) exhibited excellent performance with 100% proficient result for HPV type detection from all participants, compared to other global companies. Furthermore, as Seegene’s HPV DNA assay can detect up to 28 kinds of HPV genotypes individually including HPV16 and HPV18, it has been considered as the most suitable product for cervical cancer diagnosis and follow-up. The result of this study was presented at the 30th International Papillomavirus Conference held in Lisbon, Portugal (Sep. 17-21, 2015). * Percent proficient results of HPV types as claimed to be detected by test Reference 1) Eklund C et al. The 2010 Global Proficiency Study of Human Papillomavirus Genotyping in Vaccinology. J Clin Microbiol (2012) 50(7): 2289-98 2) http://www.who.int/biologicals/areas/human_papillomavirus/WHO_HPV_LabNet/en/.
Nov 04, 2015｜ Anyplex™Ⅱ HPV28 Detection
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Obtained CE-IVD marking for Anyplex™ MERS-CoV Real-time Detection
Anyplex™ MERS-CoV(upE) Real-time Detection, Anyplex™ MERS-CoV (upE&orf1a) Real-time Detection Anyplex™ MERS-CoV (upE) Real-time Detection is a multiplex real-time one-step RT-PCR assay targeting upstream of the E protein gene (upE) for detection of MERS-CoV. The assay for the upE target is considered highly sensitive and is recommended for screening of MERS-CoV. Anyplex™ MERS-CoV (upE&orf1a) Real-time Detection is a multiplex real-time one-step RT-PCR assay targeting upstream of the E protein gene (upE) and orf1a gene for screening and confirmation of MERS-CoV.
Jul 27, 2015｜ Anyplex™ MERS-CoV(upE & orf1a) Real-time Detection
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Obtained CE-IVD marking for Allplex™ Gastrointestinal Full Panel Assay
Multiplex One-step RT Real-time PCR assay for reliable test results Allplex™ Gastrointestinal Panel Assay is a multiplex One-step RT Real-time PCR assay that detects and identifies 25 GI pathogens including 6 viruses, 13 bacteria and 6 parasites simultaneously. Based on Seegene’s proprietary MuDT™ technology, this assay makes it possible to report multiple Ct values of each pathogen in a single channel using real-time PCR instruments.Allplex™ gastrointestinal Panel Assay Comprehensive assay for the detection and identification of 25 gastrointestinal pathogens using One-step RT Real-time PCR
May 20, 2015｜ Allplex™ Gastrointestinal Panel Assays
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Launched Allplex™ Respiratory Full Panel Assay
Multiplex One-step RT Real-time PCR assay for reliable test results Allplex™ Respiratory Full Panel assay that composed of 4 different panels is a multiplex One-step RT Real-time PCR assay to detect and identify 16 viruses, 7 bacteria and 3 Flu A subtypes in patient’s specimens. Based on Seegene’s proprietary MuDT™ technology, this assay makes it possible to report individual Ct value of multiple pathogens in a single channel on real-time PCR instrument.Allplex™ Respiratory Full Panel AssayComprehensive assay for the detection and identification of 26 pathogens using One-step RT Real-time PCR
Mar 23, 2015｜ Allplex™ Respiratory Panel Assays
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Obtained CE-IVD marking for Anyplex™ II Thrombosis SNP Panel Assay
Thrombosis is the formation of a blood clot inside a blood vessel, obstructing the blood flow of the cardiovascular system. Several thrombosis associated single nucleotide polymorphisms (SNPs) have been identified and reported to significantly increase the risk of venous thrombosis. One SNP (G20210A) in the Factor II gene has been found to be associated with increased prothrombin levels and an increase in the risk for venous thrombosis in heterozygotes. Three SNPs (R506Q, H1299R and Y1702C) in the factorⅤ genes are one of the most important genetic risk factors for inherited thrombophilia. Two SNPs (C677T and A1298C) in the MTHFR gene cause reduction of MTHFR enzyme activity and heterozygosity for both C677T and A1298C is considered to be a risk factor for venous thrombosis. Anyplex™ II Thrombosis SNP Panel Assay is designed to detect and discriminate six SNPs (1 in Factor II, 3 in Factor V and 2 in MTHFR) in a single tube using the mTOCE™ technology.Anyplex™ II Thrombosis SNP Panel Assay Simultaneous detection of Six SNPs in Factor II, Factor V, and MTHFR genesAnyplex™ II Thrombosis SNP Panel Assay is designed to detect and discriminate six SNPs (1 in Factor II, 3 in Factor V and 2 in MTHFR)
Aug 01, 2014｜ Anyplex™Ⅱ Thrombosis SNP Panel Assay