South Korean FDA

The workflow was cleared by the South Korean Ministry of Food and Drug Safety for the typing of HLA-A, B, C, DRB1, and DQB1 by next-generation sequencing.

The Seoul-based company also recently raised $1.9 million in series B funding and is targeting between $7 million and $8 million to close the round.

NGeneBio said this week that its next-generation sequencing panel has been approved as an IVD, the first NGS test to be cleared in Korea.

Gencurix's assay can be used to select which non-small cell lung cancer patients will respond to tyrosine kinase inhibitors.

The assay is based on real-time reverse transcriptase PCR that will identify Zika in human serum or urine. 

NGeneBio is moving ahead with plans to have the test cleared for diagnostic use in Korea, while envisioning a 2019 submission to the US FDA.

The Korean molecular diagnostics startup is planning to launch the new offering in Europe, as well as China and other Southeast Asian countries.

Gencurix aims to achieve US FDA 510(k) clearance for its GenesWell BCT breast cancer prognostic test next year.

The approval comes about five months after the RT-PCR-based kit, which also detects Dengue and Chikungunya, received CE-IVD marking.

The US Food and Drug Administration has already granted EUA to the test, which detects viral RNA in serum and urine.

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