New Generation Gene Amplification Test System Obtains Product Certification

Nano Convergence Technology Institute, Joint Development with BioTNS

[Asia Economy Reporter Kim Bong-su] The Nano Convergence Technology Institute announced on the 18th that the 'Micro Digital Gene Amplification Test (PCR) System (μ-dPCR System)', jointly developed with the domestic bio venture company BioTNS, has obtained the New Excellent Product (NEP) certification from the National Institute of Technology and Standards.

Micro Digital PCR is a next-generation PCR that enables absolute quantification and has very high precision, unlike conventional PCR. It is the only product in Korea to have completed certification for a Micro Droplet-based Digital PCR system.

The newly developed 3rd generation digital PCR system is the first micro droplet-based digital PCR commercialized in Korea, securing diagnostic accuracy of over 99.99%, making it widely applicable not only for accurate COVID-19 diagnosis but also in cancer diagnosis fields. It is developed using the micro droplet method, which holds a dominant position in the global market, making it easy to pioneer overseas markets as well as domestic ones.

It obtained domestic medical device approval in May and NEP certification in September, and plans to secure U.S. Food and Drug Administration (FDA) approval and European CE certification in 2022.

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