Korean diagnostic kit developers are gearing up to fast track the detection of the new deadly coronavirus which is spreading at a breakneck speed in China and around the world, with some expecting to reach the commercial markets within this month.

Kogene Biotech recently developed a gene diagnostic agent for the virus and submitted documents to Korea Centers for Disease Control and Prevention (KCDC) for emergency use assessment and listing (EUAL).

The EUAL procedure was set up as an extraordinary process to allow the use of in-vitro diagnostic (IVD) products without formal approval during the epidemic. The new reagent was developed according to the detection method guidelines announced by the World Health Organization and KCDC. A company official said demand is rising from Japan and several countries in Europe and Southeast Asia where confirmed cases are reported, and actual orders and commitments are expected to be made after the upcoming Medlab Expo in Dubai this week.

There are no proven preventive or therapeutic products for the 2019-Novel Coronavirus.

TCM Biosciences already developed a TCM-Q Corona Ⅲ, a new diagnostic kit to test the virus infection. The company plans to file for the EUAL procedure within two to three weeks. A cotton swab is used to collect a sample from the patient’s nasal cavity for isolation of any ribonucleic acid from the coronavirus. TCM Biosciences said the internal development process took two to three months and it aims to file for EUAL by the third week of this month.

PCL is in the process of commercializing its multiplex diagnostic kit to detect the virus. The new kit is expected to be used immediately upon approval by the government. PCL has a track record of developing a multiplex fast detection system for deadly viruses at the request of KCDC in 2017.

Bioneer and LabGenomics are also speeding up efforts to develop diagnostic kits for the coronavirus based on their successful launches of similar kits during the outbreak of Middle East respiratory syndrome (MERS) and Zika virus. Bioneer is preparing documents to apply for the EUAL procedure, while LabGenomics is anticipating commercialization after six to eight weeks.

Efforts to develop diagnostic technology are also seen in the public sector. On Jan. 30, Center for Convergent Research of Emerging Virus Infection (CEVI) under Korea Research Institute of Chemical Technology signed an agreement with Wells Bio, a subsidiary of Kosdaq-listed Accessbio, for joint development and commercialization of molecular and immunological diagnostics to detect a gene specific to the 2019-Novel Coronavirus and a virus antigen protein. CEVI is a partnership of eight state-funded research centers with an aim to develop technologies to identify, prevent, treat and contain high-risk new and mutated viruses.

According to Biotech Policy Research Center, the worldwide IVD market that includes diagnostic kits for virus detection is expected to grow to $127 billion in 2022 from $42.7 billion in 2013.

By Kim Si-gyun and Minu Kim

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