{"id":63211,"date":"2022-04-06T11:08:15","date_gmt":"2022-04-06T11:08:15","guid":{"rendered":"https:\/\/pr.asianetpakistan.com\/?p=89593"},"modified":"2022-04-06T11:08:15","modified_gmt":"2022-04-06T11:08:15","slug":"seegenes-allplex-rv-master-assay-receives-australian-tga-approval-european-ce-ivd-mark","status":"publish","type":"post","link":"https:\/\/jordannewsgazette.com\/seegenes-allplex-rv-master-assay-receives-australian-tga-approval-european-ce-ivd-mark\/","title":{"rendered":"Seegene\u2019s Allplex\u2122 RV Master Assay receives Australian TGA approval, European CE-IVD mark"},"content":{"rendered":"
SEOUL, South Korea, April 6, 2022 \/PRNewswire\/ — Seegene Inc.<\/b> (KQ 096530), South Korea’s leading molecular diagnostics (MDx) company, today announced that its Allplex\u2122\u00a0RV Master Assay has received approval from Australia’s Therapeutic Goods Administration and achieved the European CE-IVD marking.<\/p>\n Therapeutic goods must\u00a0be entered in the Australian Register of Therapeutic Goods before they can be supplied in the country.\u00a0The CE-IVD marking is a legal requirement for marketing medical devices in the European Union.<\/p>\n Seegene’s Allplex\u2122\u00a0RV 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).<\/p>\n The Allplex\u2122\u00a0RV Master Assay\u00a0was developed based on Seegene’s decades-long know-how and applies patent technologies, like DPO\u2122, TOCE\u2122\u00a0and MuDT\u2122\u00a0(see table 2). The syndromic test allows medical specialists to swiftly find out which viruses are making the patient sick with a single sample.<\/p>\n 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.<\/p>\n 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.<\/p>\n Seegene’s independent clinical test recently conducted\u00a0in Europe using the Allplex\u2122\u00a0RV 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.<\/p>\n Symptoms of COVID-19, such as coughing and fever, can also be a sign of other respiratory infections.\u00a0This makes testing critical for proper care as treatments can vary by infection type and to reduce the potential of co-infection.<\/p>\n