-Provides Ct value of three targets in one channel; '3 Ct' PCR assay to launch 
in H1
-"Dream MDx technology" developed based on Seegene's 20-year expertise; 
combines 19 different patented technologies, including DPO(TM), TOCE(TM), 
MuDT(TM)-'3 Ct' to lay foundation for automated syndromic testing and make MDx 
more accessible

Seegene Inc. (KQ096530), South Korea's leading molecular diagnostics (MDx) 
company, today announced the development of the world's first commercialized 
PCR assay applying '3 Ct' technology. The 'Allplex(TM) HPV HR Detection' was 
showcased at the 2022 European Congress of Clinical Microbiology and Infectious 
Diseases (ECCMID) held April 23-26 in Lisbon, Portugal.

In a polymerase chain reaction (PCR), the cycle threshold (Ct) value is used to 
quantify the concentration of a viral DNA sequence (the target). Due to 
technological limitations, the conventional real-time PCR technique finds the 
Ct value of one target in one channel.

But Seegene's '3 Ct' technology can provide the Ct value of three targets in 
one channel without compromising sensitivity and specificity. The successful 
development is based on Seegene's 20-year expertise and combines 19 different 
patented technologies, including DPO(TM), TOCE(TM), and MuDT(TM). Using five 
channels in a single tube, Seegene can provide quantitative data for a total of 
15 targets. '3 Ct' has been dubbed the "dream MDx technology."

The company plans to apply '3 Ct' technology to its entire product line-up, 
including respiratory virus (RV), sexually transmitted infection (STI), 
gastrointestinal infection (GI), and urinary tract infection (UTI) assays. 
Seegene expects '3 Ct' technology to take syndromic testing to another level. 
By detecting the causative pathogen, level of infection, and potential of 
co-infection, it will help determine the priority of treatment and enhance 
patient management. '3 Ct' technology also increases testing capacity. Such 
features are expected to improve the service and cost-structure of the medical 
sector once '3 Ct' technology is widely utilized.

Seegene's first '3 Ct' technology applied product, Allplex(TM) HPV HR 
Detection, is designed to detect 14 high-risk human papillomavirus (HPV) types 
that can cause cervical cancer (See figure 1). It also provides the individual 
Ct value of each of the types allowing quantitative analysis regarding 
infection level. Early detection of HPV contributes to the prevention and 
management of cervical cancer. HPV products from other industry players provide 
individual Ct values for two high-risk types, HPV 16 and 18.

The Allplex™ HPV HR Detection, planned to be launched within the first half of 
this year, will come with a significant cost advantage compared to existing HPV 
products to increase accessibility to PCR testing, which had been difficult 
previously due to high costs. The product will also be compatible with 
Seegene's fully automated AIOS (all-in-one system). The company plans to 
introduce the industry's first 'fully automated, mass, syndromic testing 
system,' to lay the foundation for testing anywhere, including large hospitals, 
C-Labs, and even small and medium-sized clinics, and make PCR testing part of 
everyday life.

"HPV genotyping is essential for a good follow-up of a patient to observe the 
emergence, persistence or clearance of each genotype," says HPV expert 
Sebastien Hantz, Professor at the Faculty of Medicine at the University of 
Limoges in France. "Seegene is a company very involved in the development of 
molecular diagnostics tests for the detection of different pathogens. For 
certain clinical situations, like respiratory infections, syndromic testing is 
very useful."

SOURCE  Seegene Inc.

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   Caption: [Figure 1] Seegene unveils world's first commercialized '3 Ct' PCR 
assay