Seegene to pave way for PCR testing at local clinics with EU-approved multiplex test and fully automated PCR solution

SEOUL,South Korea,June 29,2022 -- Seegene Inc.(KQ096530),South Korea's leading molecular diagnostics (MDx) company,has obtained EU approval for its Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay that is compatible with the company's fully automated 'AIOS' (All-in-One System). This is expected to help small hospitals,local clinics,and public health centers effectively identify COVID-19,influenza A and B and respiratory syncytial virus (RSV).

Syndromic assay for four respiratory viruses

The Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay can detect six targets associated with the four respiratory viruses. The targets include three distinct COVID-19 genes (S,RdRp,N) to reliably identify positive cases even as new variants emerge. The test also includes two internal controls for proper sampling and testing validation. The product can deliver results within two hours when extraction-free,making it both time and cost-efficient.

'AIOS,' first fully automated high throughput MDx system for syndromic testing

AIOS,which will be released in July,supports "hands-free" PCR workflows – from nucleic acid extraction to PCR setup,gene amplification and results analysis. As AIOS is a fully automated (sample in – result out) system,it can be operated by those without PCR experience. AIOS is also compact in size and has over 30 compatible assays for syndromic testing to boost efficiency and utility,in contrast to conventional automated PCR solutions in the market that are bigger and have fewer applicable assays that detect only one to three specific targets.

AIOS is the world's first fully automated and "assembled" solution that composes independent and detachable instruments required for PCR,unlike other solutions that operate as a single unit. This makes AIOS convenient to use and maintain,while authorization procedures will be easier as existing instruments and assays can be applied. Such features are expected to allow small hospitals,and public health centers to integrate AIOS into their workflows for PCR tests,which had been limited before due to lack of instruments or specialists to operate PCR solutions.

Safe return to normalcy with Seegene's 'In-life PCR'

Healthcare specialists have warned of a resurgence of COVID-19 as early as summer – alongside an increase in flu and cold cases – as immunity from COVID-19 vaccines wane and virus-prevention measures are eased. In response to these concerns,Seegene recently launched the 'In-life PCR' initiative to embed PCR tests into our routine by increasing affordability and accessibility. It is aimed at detecting viruses especially among asymptomatic people to help end the COVID-19 outbreak as well as curb widespread transmission to prevent new pandemics. Using the Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay and AIOS,Seegene hopes to establish the foundation for routine testing.

*Syndromic testing refers to the process of simultaneously targeting multiple pathogens that have similar symptoms using a single test.