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South Korean biopharmaceutical firm Sugentech Inc. said Tuesday it has signed an agreement to export three different types of diagnostic kits for the novel coronavirus and seasonal influenza to the United States and Europe.
Under the agreement with Germany-based DiaSys Diagnostic Systems, a total of 200,000 rapid antigen kits by Sugentech to detect the COVID-19 virus will be distributed in Germany. The value of the deal was not revealed.
Sugentech's test kit that can detect both the COVID-19 virus and seasonal flu at the same time, as well as another kit to detect flu, will also be provided in Germany and the US.
Sugentech's antigen kit is the first locally made one to receive emergency approval from the US Food and Drug Administration (FDA).
The kit recently received approval from the German drug authorities, while the other two kits have won export approval from the local drug safety agency.
So far, not a single COVID-19 testing kit has received authorization from drug authorities for usage. Currently, a total of three products from two manufacturers are undergoing clinical trials.
The Ministry of Food and Drug Safety said each manufacturer has to receive approval from drug authorities from each country even with export approval.
Smaller player Bioneer Corp. earlier won approval from the ministry to conduct a clinical trial of multi-diagnostic kits that can detect both the novel coronavirus and seasonal influenza.
Other local players have also accelerated their moves to export locally made COVID-19 test kits.
Biopharmaceutical giant Celltrion Inc. earlier said it has signed an agreement worth 210 billion won ($185 million) to supply a diagnostic kit for the novel coronavirus in the US.
Under the agreement, Celltrion's rapid antigen kit, Sampinute, will be distributed by Prime Healthcare Distributors in the US.
The kit was co-developed by local health care firm BBB. (Yonhap)
Under the agreement with Germany-based DiaSys Diagnostic Systems, a total of 200,000 rapid antigen kits by Sugentech to detect the COVID-19 virus will be distributed in Germany. The value of the deal was not revealed.
Sugentech's test kit that can detect both the COVID-19 virus and seasonal flu at the same time, as well as another kit to detect flu, will also be provided in Germany and the US.
Sugentech's antigen kit is the first locally made one to receive emergency approval from the US Food and Drug Administration (FDA).
The kit recently received approval from the German drug authorities, while the other two kits have won export approval from the local drug safety agency.
So far, not a single COVID-19 testing kit has received authorization from drug authorities for usage. Currently, a total of three products from two manufacturers are undergoing clinical trials.
The Ministry of Food and Drug Safety said each manufacturer has to receive approval from drug authorities from each country even with export approval.
Smaller player Bioneer Corp. earlier won approval from the ministry to conduct a clinical trial of multi-diagnostic kits that can detect both the novel coronavirus and seasonal influenza.
Other local players have also accelerated their moves to export locally made COVID-19 test kits.
Biopharmaceutical giant Celltrion Inc. earlier said it has signed an agreement worth 210 billion won ($185 million) to supply a diagnostic kit for the novel coronavirus in the US.
Under the agreement, Celltrion's rapid antigen kit, Sampinute, will be distributed by Prime Healthcare Distributors in the US.
The kit was co-developed by local health care firm BBB. (Yonhap)