LabGenomics Launches Two PCR Kits for Diagnosing Ankylosing Spondylitis and Behcet's Disease

Genetic analysis specialist LabGenomics announced on the 25th that it has completed the in vitro diagnostic medical device product certification for two auxiliary diagnostic kits for ankylosing spondylitis and Bechet’s disease.

The newly certified product, 'LabGTM HLA-B27 Detection Kit,' is a real-time PCR-based kit that assists in the diagnosis of ankylosing spondylitis.

Ankylosing spondylitis is a chronic inflammatory autoimmune disease that causes pain and movement restrictions due to inflammation in the joints adjacent to the spine. Although the exact cause of onset is unknown, about 90% of patients are reported to carry the ‘HLA-B27’ gene. Furthermore, most patients are diagnosed after the inflammation has spread to the thoracic spine, often missing the optimal treatment window.

The 'LabGTM HLA-B51 Detection Kit' is a real-time PCR-based kit that assists in diagnosing Bechet’s disease, an inflammatory condition affecting blood vessels throughout the body. Common symptoms include ulcers near the lips or genital area, inflammation of the eyes, and arthritis, and it is primarily associated with the ‘HLA-B51’ genotype. Although relapses are frequent, early treatment can enable patients to return to daily life, highlighting the importance of early diagnosis.

LabGenomics’ two kits can amplify the HLA-B27 and HLA-B51 genes respectively, demonstrating higher sensitivity and specificity compared to other products. Additionally, the shortened PCR reaction time offers excellent speed and convenience. Both auxiliary diagnostic kits have begun sales targeting domestic diagnostic testing centers and plan to export overseas after obtaining CE certification for medical devices.

The company has successfully completed clinical discussions with domestic university hospitals for the ‘LabGTM HLA-B5801 Detection Kit,’ which detects the HLA-B5801 gene variant, as part of additional product approval. This gene is linked to severe skin reactions, a major side effect of allopurinol, the primary treatment for gout.

Mi-jin Oh, Executive Director and Head of Research at LabGenomics, emphasized, “We are expanding our lineup of diagnostic kits necessary for early diagnosis,” adding, “We will do our best to help patients receive prompt treatment and provide information essential for prognosis management to improve quality of life.”

This content was produced with the assistance of AI translation services.