Osang Healthcare said it received approval from the Ministry of Food and Drug Safety for "GeneFinder HLA-B*58:01 Plus RealAmp Kit," designed to help better treat gout patients.

The kit tests for the HLA-B5801 genetic variant, which is used to identify gout patients at risk of severe skin reactions to allopurinol, which is a common medication for the condition.

The kit employs the TaqMan Probe method for accuracy and includes both the target and internal control in one tube, facilitating convenience and efficiency in testing.

Gout is a disease where uric acid accumulates around joints, causing extreme pain and inflammation. It is aggravated by factors including obesity, westernized diets, stress, and alcohol intake.

Data from the National Health Insurance Service indicate that gout patient numbers have been rising, with a 17.1 percent increase from 2018 to 2022.

Allopurinol, while effective in treating gout, has been linked to severe cutaneous adverse reactions (SCARs) in some patients.

The risk is particularly associated with the HLA-B5801 genotype, which is more prevalent in the Korean population (around 12 percent) compared to Western populations (1-6 percent).

Before the development of Osang's kit, genetic testing for HLA-B5801 in Korea depended on imported diagnostic products.

The company expects domestic production to introduce an alternative to hospitals as it is compatible with most existing equipment in Korean hospitals and labs.

The kit's approval is part of the government's broader shift towards preemptive testing for drug-induced reactions, supported by recent reimbursement criteria changes covering genetic testing for HLA-B5801 patients prescribed allopurinol.