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Obtained Australian TGA approval for Allplex™ HPV HR Detection
Seegene has received approval from Australia’s Therapeutic Goods Administration for Allplex™ HPV HR Detection. Therapeutic goods must be entered in the Australian Register of Therapeutic Goods before they can be supplied in the country.
Nov 17, 2022｜ Allplex™ HPV HR Detection
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Obtained Australian TGA approval for Allplex™ HPV 28 Detection
Seegene has received approval from Australia’s Therapeutic Goods Administration for Allplex™ HPV28 Detection. Therapeutic goods must be entered in the Australian Register of Therapeutic Goods before they can be supplied in the country.
Nov 17, 2022｜ Allplex™ HPV28 Detection
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Obtained CE-IVDD marking for Allplex™ HPV 28 Detection
Seegene has received CE-IVD mark under European Union on In Vitro Diagnostic for Allplex™ HPV28 Detection. Allplex™ HPV28 Detection is a multiplex real-time PCR assay that enables simultaneous amplification and detection of target nucleic acids of 19 high-risk HPV types (16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82) and 9 low-risk HPV types (6, 11, 40, 42, 43, 44, 54, 61, 70) as well as Internal Control (IC)
May 20, 2022｜ Allplex™ HPV28 Detection
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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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Launched Anyplex™ II HPV28 Detection
Anyplex™ II HPV28 Detection Simultaneous detection of 28 HPV typesAnyplex™ II HPV28 Detection simultaneously detects 19 high-risk HPVs and 9 low-risk HPVs. Human papillomavirus (HPV) has been identified as the leading cause of cervical cancer in women, as well as a growing risk factor in oropharyngeal cancer. Although over 150 related HPV strains have been identified, only a subset have been identified as major risks factors for cervical cancer. While HPV16 and HPV18 have clearly been implicated as causative agents, the influence of other factors on the severity and progression of cervical cancer (e.g., viral load; persistence and clearance rates of virus over time) have only recently been recognized. In particular, the combination of multiple high- and low-risk HPV infections has now been identified as a risk factor to increased co-morbidity and disease progression. Outcome-based clinical studies in association with HPV vaccines studies are demonstrating the advantages of long-term monitoring for multiple viral genotypes infections in association with continued efficacy and cross-genotype protective. Unfortunately, the diagnostic tools to readily detect, identify and quantitatively assess co-infection by multiple HPV genotypes are not available. The Anyplex™ II HPV28 Detection has been specifically designed to address this unmet medical need through the simultaneous detection, identification and quantification of 28 HPV distinct genotypes (19 high-risk HPVs and 9 low-risk HPVs) contributing to cervical cancer and/or sexually transmitted infection. Based on Seegene’s proprietary DPO™ and TOCE™ technologies, this homogeneous assay performs on standard existing real-time PCR instrumentation to detect, differentiate high- or low-risk HPV infections. Anyplex™ II HPV28 Detection is a fast, reliable and quantitative solution to detection, identification and quantification of HPV infections, providing a much-needed multiplex diagnostic solution to assist in prognosis and long-term patient outcome.
Aug 31, 2012｜ Anyplex™Ⅱ HPV28 Detection
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Obtained CE-IVD marking for Seeplex® STD 4D ACE Detection
Simultaneously detecting 4 different STD pathogensSeegene's Seeplex® STD 4D ACE Detection has been notified at Germany CA (Competent Authorities). The CE mark will allow more opportunities for Seegene to market and sell within the European Union.
Jul 28, 2010｜ Seeplex® STD 4D ACE Detection
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Launched Magicplex™ HPV 16/18 Amplification
Magicplex™ HPV 16/18 Amplification Discrimination of HPV16 and HPV18 Using READ™ technology, this product detects and distinguishes between HPV 16 and HPV 18 viruses, which are the main cause of cervical cancer. Most cases of HPV infection end in natural recovery within several months, but in those cases where the infection persists for more than twelve months, it may lead to CIN (cervical intraepithelial neoplasia) and cervical cancer. In particular, it has been reported that HPV 16 and 18 cause approximately 70% of all cervical cancers worldwide.
Feb 06, 2010｜ Magicplex HPV 16/18 Amplification
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Launched Magicplex™ HPV 16/18 Real-time Detection
Magicplex™ HPV 16/18 Real-time Detection Discrimination of HPV16 and HPV18 Using READ™ technology, this product detects and distinguishes between HPV 16 and HPV 18 viruses, which are the main cause of cervical cancer. Most cases of HPV infection end in natural recovery within several months, but in those cases where the infection persists for more than twelve months, it may lead to CIN (cervical intraepithelial neoplasia) and cervical cancer. In particular, it has been reported that HPV 16 and 18 cause approximately 70% of all cervical cancers worldwide.
Feb 06, 2010｜ Magicplex HPV 16/18 Real-time Detection