Seegene's High Multiplex PCR Assay Capable of Detecting New Omicron Variant

SEOUL,South Korea,Nov. 30,2021 -- Seegene Inc. (KQ 096530),South Korea's leading molecular diagnostics company,today confirmed that its Allplex™ SARS-CoV-2 Master Assay is capable of detecting the Omicron's unique pattern of mutations. The well-established PCR-based test recognizes four SARS-CoV-2 genes and five notable mutations on the spike protein,all in a single test tube. This provides accurate results on whether a person is positive for COVID-19 and if they have the Omicron variant within 4 hours. To maximize its use,Seegene will support countries in need of tests,so they can rapidly detect cases of Omicron without the labor and equipment required for full genomic sequencing.

The Allplex™ SARS-CoV-2 Master Assay simultaneously detects four wild-type SARS-CoV-2 genes (E gene,RdRP gene,N gene,and S gene) and five notable S-gene mutations: HV69/70 deletion,Y144 deletion,E484K,N501Y,and P681H. Since the latest variant Omicron contains HV69/70 deletion,and P681H mutations,this CE-IVD marked test can detect Omicron.

The first Omicron (B.1.1.529)case was reported to the World Health Organization (WHO) on November 24. Just two days later,the WHO designated the variant a Variant of Concern (VOC),based on its unusually large number of mutations and early evidence of its spread. Despite a series of rapidly implemented travel bans,it has now been reported in Africa,many European countries,and a few in Asian countries.

The process for identifying novel variants typically involves next-generation sequencing of the isolated virus,which would take a few days to get the complete result. For more rapid detection,Seegene's Allplex™ SARS-CoV-2 Master Assay can detect the variant in the very first stage of screening. Public health officials can then rapidly isolate and contact trace people who are infected with this variant of concern.

"In order to contain the further spread of Omicron,it is extremely important to preemptively detect the Omicron variant at the primary screening stage. To that end,we will fully support countries in need of our tests to enable more rapid detection of the latest variant," said Dr. Jong-Yoon Chun,Seegene Founder and CEO. Along with strengthening surveillance testing,the implementation of relevant quarantine measures will give more time for countries around the world to contain the rising Omicron infections and protect their citizens.