Seegene has received CE-IVD mark under European Union on In Vitro Diagnostics Medical Devices for Anyplex™ MTB/NTMe Real-time Detection. This assay is a Real-time PCR assay to detect simultaneously Mycobacterium tuberculosis dissociated from non-tuberculosis mycobacteria and include whole process control for assay validity.
May 12, 2017｜ Anyplex™ MTB/NTMe Real-time Detection
Allplex™ GI-Virus Assay 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 Norovirus GI, Norovirus GII, Rotavirus, Adenovirus, Astrovirus and Sapovirus which cause gastrointestinal disease in a single tube.
Apr 26, 2017｜ Allplex™ GI-Virus Assay
Allplex™ Bacterial Vaginosis Assay simultaneously detects 7 bacteria (G. vaginalis, A. vaginae, Megasphaera type 1, BV-associated bacteria 2, Mobiluncus spp., B. fragilis, Lactobacillus spp.) associated with vaginosis. It provides quantitative information of 3 major bacteria (G. vaginalis, A. vaginae, Lactobacillus spp.). Based on Seegene’s proprietary MuDT™ technology, this assay makes it possible to report individual Ct value of multiple bacteria in a single channel. The CE-IVD mark will allow more opportunities for Seegene to market and sell within the European Union.
Dec 15, 2016｜ Allplex™ Bacterial Vaginosis Assay
Allplex™ Respiratory Panel 3 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 Bocavirus, Rhinovirus and three Coronaviruses (NL63, 229E, OC43) which cause respiratory infections in a single tube.
Nov 24, 2016｜ Allplex™ Respiratory Panel 3
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.
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
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
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