South Korea-based molecular diagnostics company Seegene has secured Australia’s Therapeutic Goods Administration (TGA) approval and European CE-IVD marking for its Allplex RV Master Assay.

Allplex RV Master Assay can detect 21 targets for 19 respiratory viruses in a single tube, including Covid-19, flu, and common colds.

It can detect three genes of Covid-19, Flu A, Flu B, metapneumovirus, two types of respiratory syncytial virus, four types of parainfluenza virus, and six types of adenovirus and three types of human rhinovirus, said the firm.

Seegene developed the Allplex RV Master Assay on its DPO, TOCE and MuDT technologies.

With a single sample, the syndromic test aids medical doctors to detect the virus responsible for the patient’s illness.

According to Seegene’s recent clinical survey on 1,928 people in Europe using Allplex RV Master Assay, 318 people (16.5%) were infected with respiratory viruses other than Covid-19, and 22 people (6.9% of the infected people) had two or more viruses.

Covid-19 symptoms, including coughing and fever, can also be signs of other respiratory illnesses, making testing essential because the treatments differ based on the type of illness and to decrease the possibility of co-infection.

The company said the assay is adaptable to every condition as countries change policy regularly to gain normalcy.

Sygehus Sonderjylland’s Dr Tove Havnhøj Frandsen/ RenTov Consult, who led Seegene’s clinical test in Europe 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.”

Australian TGA approval is mandatory for therapeutic goods to enter the Australian market and CE-IVD marking is a necessary certification to market medical devices in the European Union.