South Korea's biotechnology company specializing in molecular diagnostics, Seegene Inc. (KQ096530) said Tuesday that it has CE-IVD marked the saliva-based testing application for Allplex™ SARS-CoV-2 Assay and Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay, and that the products with the feature are now available in Europe. The new addition of saliva sample collection feature is set to offload burden of collecting large volume of specimen samples for healthcare professionals on the frontlines of the COVID-19 pandemic.

With the newly added feature, the saliva sample collection test can be used interchangeably with nasopharyngeal specimen collection test, normally used for multiplex real-time PCR tests for screening the novel coronavirus. Korea’s leading molecular diagnostics firm said its saliva sample collection test provides additional option for the easy, safe and convenient sample gathering without having to compromise sensitivity and specificity of the test.

Separately, a study conducted by Children’s National Hospital in Washington DC taken in the July-to-September period in 2020 showed Seegene’s Allplex™ 2019-nCoV Assay, an earlier version of the company’s COVID-19 diagnostic test, was found to be best suited among the four competing FDA EUA-approved COVID-19 PCR assays for testing saliva specimens collected from participants. It added that the sensitivity of viral detection was equivalent to that of nasopharyngeal specimens when tested on Seegene’s Allplex™ 2019-nCoV Assay.

Seegene’s saliva sample collection feature can also eliminate the need for materials and labor associated with nucleic acid extraction, as the test is being performed directly from the raw saliva collected from participants. An official from Seegene said the saliva sample collection feature, together with the extraction-free application, also CE-IVD marked in November, will enable labs to carry out massive testing. The extraction-free application allows labs without extraction equipment, previously a prerequisite for molecular diagnosis testing, and was recently made available in Europe for Allplex™ SARS-CoV-2/FluA/FluB/RSV Assay.

Presenting the company’s first ever saliva specimen collection test, an official from Seegene said the new feature is deemed an efficient method of collecting large volume of specimens, especially at a time when mutant coronavirus in Europe has recently prompted global alarm rly December and has exported more than 55 million COVID-19 tests to more than 60 countries in the first three quarters this year. The company recently announced its plans to expand its annual production capacity to KRW 5 trillion by early next year.