Australian TGA approves Seegene’s Allplex RV master assay

Australia’s Therapeutic Goods Administration (TGA) has granted approval for South Korean molecular diagnostics (MDx) company Seegene’s Allplex RV Master Assay.

Developed based on the company’s know-how and patent technologies, such as Dual Priming Oligonucleotide (DPO), Tagging Oligonucleotide Cleavage and Extension (TOCE) and Multiple Detection Temperatures (MuDT), the assay has been designed to differentiate 21 targets for 19 different respiratory viruses, including Covid-19, flu and common colds.

The Allplex RV Master Assay is capable of identifying three Covid-19, Flu A, Flu B, metapneumovirus genes, and two respiratory syncytial virus types.

It can also identify four parainfluenza virus types, six types of adenovirus and three human rhinovirus types.

Using the syndromic test, medical specialists will be able to quickly identify the virus making a patient sick from one sample.

An independent clinical test recently conducted by Seegene in Europe using the Allplex RV Master Assay involved 1,928 people.

It found that 16.5% of the people tested positive for respiratory viruses, excluding Covid-19, and 6.9% of that figure had contracted two or more viruses.

Dr Tove Havnhøj Frandsen of Sygehus Sonderjylland (Hospital of Southern Jutland)/RenTov Consult led the clinical test.

Frandsen said: “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.

“The assay is expected to be well-utilised as winter approaches in Australia and South America and as the world turns to live with Covid-19 endemically.”

Additionally, the assay has achieved the European CE-IVD marking, a legal requirement to market medical devices in the European Union. Medical Device Network