ViGenCell obtains approval for HLA-B5801 genetic diagnostic kit for adverse reactions to gout treatment

ViGenCell, a company specializing in immunotherapy, announced on Friday that it has obtained approval from the Ministry of Food and Drug Safety (MFDS) for its "ViGen HLA-B5801 RT Kit," a genetic test diagnostic kit for pre-screening to prevent adverse reactions to therapeutic agents in gout patients.

The newly approved product identifies the HLA-B5801 gene, which is linked to a high likelihood of severe cutaneous adverse drug reactions (SCARs) caused by the widely prescribed gout medication Allopurinol. 

This diagnostic kit allows for pre-testing to prevent such adverse reactions by detecting the presence of the HLA-B5801 gene, which has been proven to be associated with SCARs. 

In South Korea, the number of gout patients has risen by about 73% over the past decade, from 308,728 in 2014 to 535,100 in 2023, driven by changes in diet and lifestyle. 

Allopurinol, a widely used treatment for gout, is the number one ingredient responsible for compensation for damage-related to adverse drug reactions and can cause long-term aftereffects. 

Incidence of allopurinol-induced SCARs is related to the HLA-B5801 genotype, and the proportion of this genotype in Koreans is about 12%, which is higher than that of Westerners. 

ViGenCell’s "ViGen HLA-B5801 RT Kit" is compatible with most equipment used in domestic hospitals and contract testing organizations. 

The product employs the TaqMan Probe PCR method, which is performed by adding a fluorescent substance to a specific DNA sequence fragment of the target, and uses freeze-dried technology for enhanced accuracy and convenience. 

Additionally, results can be easily verified using a dedicated viewer program. 

“With the full insurance coverage of HLA-B5801 gene testing for patients requiring Allopurinol administration, the number of pre-tests will further increase. We are pleased to provide gout patients with the opportunity to choose safer treatment options along with genetic pre-diagnosis through the ‘ViGen HLA-B5801 RT Kit.,” said Choi Hee-baeg, Head of Business at ViGenCell.

Write to Woo-Sang Lee at idol@hankyung.com