Seegene's Allplex™ RV Master Assay receives Australian TGA approval, European CE-IVD mark

Test detects 21 targets for 19 respiratory viruses in single tube,including COVID-19 and flu

Assay result of Seegene's decades-long know-how,applies DPO∙TOCE∙MuDT technologies

"Optimal solution for safe return to normalcy as distancing restrictions eased"

SEOUL,South Korea,April 6,2022 -- Seegene Inc. (KQ 096530),South Korea's leading molecular diagnostics (MDx) company,today announced that its Allplex™RV Master Assay has received approval from Australia's Therapeutic Goods Administration and achieved the European CE-IVD marking.

Therapeutic goods mustbe entered in the Australian Register of Therapeutic Goods before they can be supplied in the country.The CE-IVD marking is a legal requirement for marketing medical devices in the European Union.

Seegene's Allplex™RV Master Assay can distinguish 21 targets for 19 different respiratory viruses,including COVID-19,flu,and common colds. Specifically,the assay can identify three genes of COVID-19,Flu A,Flu B,metapneumovirus,two types of respiratory syncytial virus,four types of parainfluenza virus,six types of adenovirus and three types of human rhinovirus (see table 1).

The Allplex™RV Master Assaywas developed based on Seegene's decades-long know-how and applies patent technologies,like DPO™,TOCE™and MuDT™(see table 2). The syndromic test allows medical specialists to swiftly find out which viruses are making the patient sick with a single sample.

The world has turned its focus to living with COVID-19 endemically and relaxed social distancing and mask restrictions have created an environment for various respiratory viruses to circulate with ease.

Recent data from FluTracking,a surveillance system used to detect influenza in Australia,found 10-15% of respondents with fever and cough symptoms in some cities,as the southern hemisphere heads into the winter season.

Seegene's independent clinical test recently conductedin Europe using the Allplex™RV Master Assay on 1,928 people also found that 16.5% (318 people) tested positive for respiratory viruses,excluding COVID-19. Of that figure,6.9% (22 people) had contracted two or more viruses.

Symptoms of COVID-19,such as coughing and fever,can also be a sign of other respiratory infections.This makes testing critical for proper care as treatments can vary by infection type and to reduce the potential of co-infection.

A study published in The Lancetshows that patients that contracted both COVID-19 and flu had more than double the risk of death,while the need for invasive medical ventilation jumped by four-fold.

The Allplex™RV Master Assay has been designed in consideration of such circumstances as countries shift policies to get everyday life back to normal.

"Allplex™RV Master Assay can detect respiratory viruses that can occur all-year round to simplify the diagnostic of the 'new normal' respiratory virus composition," said Dr. ToveHavnhøj Frandsenof Sygehus Sonderjylland (Hospital of Southern Jutland)/RenTov Consult,who led Seegene's clinical test in Europe. "The assay is expected to be well-utilized as winter approaches in Australia and South America and as the world turns to live with COVID-19 endemically."

Table 1. Allplex™ RV Master Assay targets

VIRUS

VIRUS SUB-TYPE

COVID-19

(Target gene)

COVID-19

(S,N,RdRP gene)

Influenza A

Influenza A

Influenza B

Influenza B

Metapneumovirus (MPV)

MPV

Respiratory Syncytial Virus (RSV)

RSV A,RSV B

Parainfluenza virus (PIV)

PIV1,PIV2,PIV3,PIV4

Adenovirus (AdV)

AdV A,AdV B,AdV C,AdV D,AdV E,AdV F

Human Rhinovirus (HRV)

HRV A,HRV B,HRV C

Table 2. Seegene's patent technologies

DPO™

(Dual Priming Oligonucleotide)

Multiple target amplification technology that enhances target

specificity and minimizes non-specific amplification commonly

occurred in multiplex PCR

TOCE™

(Tagging Oligonucleotide

Cleavage and Extension)

Oligonucleotide chemistry solution for homogenous high

multiplex real-time PCR. TOCE technology enables detection

and differentiation of multiple targets in single fluorescence

channel through melting temperature analysis

MuDT™

(Multiple Detection Temperatures)

Analytical real-time PCR technology which enables detection of

multiple targets with individual Ct value in single channel without

melting curve analysis