Seegene Inc

With VALGENT-3 clinical study report, Seegene proving global product once again

Dec 03, 2018

On December 2, 2018, Seegene presented the clinical study results of Seegene HPV product through VALGENT-III framework at “EUropean Research Organisation on Genital Infection and Neoplasia congress 2018 (EUROGIN 2018)” held in Portugal and proved the excellence of Seegene HPV product.

VALGENT (VALidation of HPV GENotyping Tests of Human Papillomavirus) is a multinational and multicenter clinical study framework for test comparison and validation of HPV assays in general and genotyping capabilities in particular. The test systematically verifies and statistically analyze in a formalized and uniform manner, thus this framework became an important guidelines in the HPV academia. Currently, three VALGENT study rounds were completed and validation of two of Seegene products (Anyplex II HPV HR and HPV28 Detection) were included in all three rounds and obtained its performance verification compared to those of global companies in 2015.

This validation result was presented by Dr. Marc Arbyn, an authority of HPV genotyping tests from Belgium, at the EUROGIN symposium. Especially, in accuracy comparison with COBAS HPV DNA Test and Linear Array of Roche and Hybrid Capture 2 of QIAGEN, the performance was proven to be at least equivalent, and the high clinical significance between the performance and the cellular exam result was shown so that the excellence of Seegene products was officially proven once again. In addition, the result of this clinical evaluation was published in Journal of Clinical Microbiology in October 2018.

Meanwhile, in the symposium under the theme “Beyond the current HPV diagnosis”, focused on the excellent clinical performance findings of Seegene HPV product not only for cervical cancer but also for head and neck cancer. Dr. Pavon Rivas, a cancer diagnosis authority from Spain, also presented that the products of Seegene showed the higher concordance rate compared with the preexisting gold standard method for head and neck cancer screening. This result has a high significance proving that Anyplex™ II HPV28 that is currently in use for cervical cancer diagnosis can even be used for head and neck cancer diagnosis.

EUROGIN is an international academic conference where exchanges clinical studies, epidemiological research, latest test methods related to human papillomavirus (HPV) infection and screening and prevention of cervical cancer.