CancerRop said Thursday that it has acquired CE-IVD (Conformite Europeen In-vitro Diagnostic Device) certification as well as export approval from the Ministry of Food and Drug Safety for its Q-Sens 2019-nCoV diagnostic kit.
|CancerRop's Q-Sens 2019-nCoV diagnostic kit|
Unlike the previous export approval for diagnostic kits, the ministry put forth stricter requirement to CancerRop, requesting the company to submit clinical evaluation data, under the government’s new regulation put into effect on Feb. 19, the company said.
According to CancerRop, the government is reinforcing a more stringent process for exporting diagnostic reagents for COVID-19 than those for local use, which only evaluates the performance evaluation data of the diagnostic reagent manufacturers.
“The strengthened export permit requirements for the COVID-19 diagnostic kit seems to take into account the international credibility of Korean-made diagnostic kits,” the company said. “Our diagnostic reagents have shown excellent results by undergoing clinical evaluations that demonstrated safety and efficacy at Myongji Hospital,” the company said. “The Korean regulator granted approval based on these results.”
The company emphasized that it independently produced core raw materials, such as diagnostic reagents, thanks to its Korea good manufacturing practice (KGMP)-grade production facilities, adding that negotiations are briskly underway to export raw materials and diagnostic kits.
In January, CancerRop completed the development of a diagnostic kit and applied for the emergency use of in vitro diagnostic products for infectious diseases approval to the Korea Centers for Disease Control and Prevention (KCDC). The company has also acquired CE certification and is currently discussing export contracts with its partners in China, Southeast Asia, South Africa, and Europe for the product’s quick commercialization.
CancerRop’s detection kit developed can push up the accuracy of the diagnosis results to 99.9 percent, while decreasing the time required to less than two hours. The kit tests RNA extracted from samples such as sputum, nasopharyngeal smear, and bronchial alveolar lavage fluid of a suspected patient by conducting a real-time reverse transcription-polymerase chain reaction, the company added.
CancerRop, an affiliate of Myongji Hospital led by Chairman Lee Wang-jun, is a company specializing in the development of molecular diagnostic sequencing immunotherapy. The company develops and commercializes molecular diagnostic techniques for diagnosing genetic diseases occurring at all stages of human life, while exclusively producing a micro-array based on the genes obtained from the Korean Genome Project.
The company is also focusing its attention on developing a cancer vaccine, using recombinant overlapping peptide (ROP) technology.
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