Seegene, a biotechnology company specializing in molecular diagnostics, said Wednesday it finished the development of the world's first-ever variant diagnostic test that can simultaneously detect COVID-19 and screen multiple virus variants, with a single multiplex real-time PCR testing. The 'Allplex? SARS-CoV-2 Master Assay' can detect both coronavirus and its variants in the initial round of testing. It's an ideal way of screening coronavirus genes, as the pandemic continues after being coupled with more contagious variants that have spread to at least 70 countries.

The new COVID-19 test detects a total of 10 targets including four coronavirus genes (E gene, RdRP gene, N gene and S gene) as well as five defined virus variants notably spotted in the most recognized lineages. Those variants include B.1.1.7 (U.K. lineage of concern, associated with the N501Y mutation), B.1.351 (South African lineage defined by 501Y.V2), P.1 (Brazilian lineage with variants of biological significance E484K, N501Y and K417T), B.1.1.207 (U.S. lineage). Detecting four coronavirus genes in a single tube of assays can only be realized by Seegene and its unique technology, one that is extremely vital when distinguishing the virus that keeps on evolving at a fast rate.

Seegene's technology can precisely detect various types of mutant variants including those of point mutation and deletion of amino acids.

Additionally, Seegene's 'Allplex? SARS-CoV-2 Master Assay' can pre-screen suspicious new variants that are believed to carry composition of the already discovered mutations. Recently multiple COVID-19 mutations have been reported to overlap, like the N501Y mutation, now being spotted in multiple lineages, after having been reported in the U.K. and South African variants.

'Allplex? SARS-CoV-2 Master Assay' can also be used in conjunction with 'Allplex? RV Essential Assay,' a one-step assay for screening 17 target causative viruses for respiratory infections. With a single swab sample, the two provide high usability in detecting essential respiratory pathogens accurately and comprehensively.

Seegene also utilized its original technology of endogenous internal control system that verifies entire testing process, starting with the sample collection, making the less-invasive saliva sampling method a viable option.

The company added the extraction-free application is currently under development. The extraction-free method can shorten the testing process and eliminate concerns over possible extraction reagent and consumable shortages.

By incorporating Seegene's proprietary high multiplex technology, Seegene becomes the first in the market to target both COVID-19 and variants with a single tube of reagent. The company already has over 150 multiplex diagnostic tests in its portfolio including HPV and STI assays. With the company's big data auto-surveillance in silico system, the diagnostic firm said it closely monitors and analyzes global databases on the coronavirus and its variants, enabling swift response with further product development.

Dr. Jong-Yoon Chun, CEO of Seegene said its new COVID-19 test will "help lessen the burden of the testing process as the turn-around-time for screening both COVID-19 and virus variants will drop to less than two hours after nucleic acid extraction." Currently, health authorities have to go through an extra round of genomic sequencing to distinguish the existence of COVID-19 variants after standard PCR tests, automatically leading to a more prolonged testing time. Dr. Chun added its "variant diagnostic test will ultimately boost massive testing ability in its fight against COVID-19, coupled with more contagious mutant variants."

The need to screen COVID-19 variants has become an essential tool in effectively controlling infections and handling patient care, following worrisome developments that some COVID-19 vaccines produce a weakened immune response against the contagious virus variants.

Seegene previously introduced 'Allplex? SARS-CoV-2 Variants Ⅰ Assay,' a diagnostic test capable of identifying origins of multiple variants. This particular test can detect and differentiate virus variations that seem to have originated from the UK, South Africa, Japan and Brazil as well as additional suspicious variants. The two diagnostic assays can be complimentary in that it can screen COVID-19 as well as filter and identify the origins of virus variants, allowing health authorities to better trace the virus and handle patients. 

Dr. Chun added that "Seegene will continue to monitor the progress of virus variants and provide with more COVID-19 diagnostic tests to help contain the spread of COVID-19."  

About Seegene, Inc.

Founded in Seoul, South Korea in 2000 and with subsidiaries in the U.S.A., Canada, Germany, Italy, Mexico, Brazil, and the Middle East, Seegene, Inc. is an in-vitro diagnostics (IVD) company that has been turning concepts into products through its pioneering R&D activities. Seegene owns its original patent technology including DPO? (Dual Priming Oligonucleotide) for multiple target amplification; TOCE?, for multiple target detection in a single channel; MuDT?, the world's first real-time PCR technology that provides individual Ct values for multiple targets in a single channel for quantitative assays.; and mTOCE? multiplex mutation detection technology. With these cutting-edge molecular diagnostic (MDx) technologies applied to diagnostic kits and other tools, Seegene has enhanced the sensitivity and specificity of PCR (polymerase chain reaction) to unprecedented levels, providing multiplex PCR products that target and detect genes of multiple pathogens simultaneously, saving testing time and cost. Seegene continues to set new standards in MDx providing new, cost-effective innovations.