Ngenbio Voluntarily Withdraws Application for In Vitro Diagnostic Medical Device Manufacturing Approval
[Asia Economy Reporter Jang Hyowon] On the 7th, Enzen Bio announced that it voluntarily withdrew its application for manufacturing approval of the tumor-related genetic test reagent (Class 3) ‘BRCAaccuTest PLUS,’ which was submitted to the Ministry of Food and Drug Safety on July 23 last year.
The company stated that it decided to voluntarily withdraw the application because it was difficult to submit some of the supplementary materials requested by the Ministry of Food and Drug Safety, specifically the clinical performance test report, within the supplementation period due to the time required for the IRB (Institutional Review Board) review schedule.
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An Enzen Bio official said, “BRCAaccuTest PLUS is a product for which manufacturing approval was additionally applied to improve the performance and reduce the cost of BRCAaccuTest, which obtained manufacturing approval on December 26, 2017,” adding, “Following the voluntary withdrawal of the manufacturing approval application for BRCAaccuTest PLUS on this day, we will reapply for manufacturing approval as soon as the supplementary materials are completed.”
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