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February 25, 2022

Seegene obtains CE-IVD mark for SARS-CoV-2 fast MDx Assay

The Allplex SARS-CoV-2 fast MDx Assay can offer results in 30 minutes with an accuracy equal to RT-PCR tests.

Seegene has reported that its Allplex SARS-CoV-2 fast MDx Assay obtained CE-IVD marking for streamlining on-site testing.

The company noted that the test is optimised for the ‘living with Covid-19’ era, where bulk, rapid and cost-effective testing is necessary. 

Said to be the fastest among Seegene-developed diagnostics assays, the latest test can provide results in 30 minutes with an accuracy equal to reverse transcription-polymerase chain reaction (RT-PCR) tests. 

As it is inexpensive and anticipated to be widely available, the test could be used at schools, airports and various other large-scale facilities.

It leverages an isothermal amplification method that does not need a thermal cycler for the amplification process, thereby reducing the turnaround time. 

In addition, the improved turnaround times can enhance lab testing capacity by up to five times with the company’s current PCR instruments. 

The Allplex SARS-CoV-2 fast MDx Assay can also identify SARS-CoV-2 viruses from individuals who are asymptomatic. 

With the latest development, the company will permit labs to process the assay leveraging AIOS, a fully automated MDx system of Seegene.

Merging these will provide a ‘hands-free’ workflow from extraction to result interpretation, alleviating the need for manual intervention. 

This is intended to boost access to testing at locations that require rapid, precise and large-scale testing. 

Furthermore, the company noted that the test will be priced lower than standard RT-PCR assays.  

Seegene chief sales and marketing officer Ho Yi said: “Large-scale on-site testing is more important than ever as many countries decide to live with Covid-19. 

“The newly developed test can provide accurate results and greatly reduce the turnaround time. 

“Seegene will target global markets that require large-scale on-site testing by offering the new test at a reasonable price and will make efforts to normalise daily lives by fostering an environment where anybody can get swiftly tested.”

The development comes after the company entered an agreement to deliver four million Covid-19 tests to the Ministry of Health of Brazil.

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