Gencurix said that it has developed a new COVID-19 detection kit and plans to launch the product in Korea and the EU after receiving regulatory approval.
The product is a gene amplification-based PCR (polymerase chain reaction) kit for diagnosing COVID-19 infection made under the World Health Organization (WHO) guidelines. The company applied for an emergency use approval to the Korea Centers for Disease Control and Prevention (KCDC) in late February.
Companies can apply for the emergency use approval system when there is no diagnostic product approved in Korea despite the need for one due to the pandemic of infectious diseases.
Under this system, companies and medical workers can temporarily manufacture, sell and use diagnostic kits and reagents as requested by the KCDC, under the approval from the Minister of Food and Drug Safety.
“The newly developed diagnostic kit has an improved specificity for COVID-19,” a company official said. “Diagnostic errors, including reverse transcription, can be easily identified, making inspection more reliable than other products.”
Currently, four Korean, including Kogene and Seegene, have received approval for a COVID-19 diagnostic kit. Due to the fierce local competition, Gencurix said that it is looking to expand its product overseas.
To this end, the company is undergoing an approval process for its new diagnostic kit in the EU and expects to receive CE-IVD (CE In-vitro Diagnostic Device) certification by next week.
According to the company, the registration of CE-IVD allows the sale of its diagnostic kit in many countries in Europe, Southeast Asia, Oceania, and the Middle East.
The company has also registered itself as a supplier for the U.N. Global Marketplace (UNGM), which is a procurement portal of the U.N. System while completing registration at FIND, a non-profit international organization that supports innovative in vitro diagnostic devices.
Gencurix is also developing a COVID-19 rapid immunodiagnostic kit with Plexense, a local biopharmaceutical firm, by licensing in the latter’s immunodiagnostic sensor platform technology, also known as ACCEL ELISA.
“ACCEL ELISA can diagnose viruses with 3ppt (particle per trillion) sensitivity within 15 minutes,” the company said. “Traditional corona assays involve the use of immunoglobulins (IgM / IgG) to detect viral infections indirectly.”
Gencurix plans to collaborate with Plexense to develop an immunodiagnostic kit that improves false positives and improves accuracy using an immune response that can directly identify antigens and antibodies of viruses in infected samples, the company added.
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