Full-Scale Launch of Precision Medical Diagnosis Project
Certification of Auxiliary Diagnostic Kit for Ankylosing Spondylitis
[Asia Economy Reporter Myunghwan Lee] ViGenCell, a company specializing in immune cell therapy, announced on the 30th that it will officially start its precision medical diagnostics business by obtaining manufacturing approval for in vitro diagnostic medical devices and completing product certification for an auxiliary diagnostic kit for ankylosing spondylitis.
Earlier this month, ViGenCell obtained manufacturing approval for in vitro diagnostic medical devices from the Ministry of Food and Drug Safety and recently completed product certification for the ankylosing spondylitis auxiliary diagnostic kit, 'ViGen HLA-B27 RT KIT.'
The kit, which has recently completed product certification, targets ankylosing spondylitis, an autoimmune rheumatic disease characterized by inflammation gradually occurring and hardening in multiple areas including the spine, causing pain and movement restrictions. Although the exact cause of onset is unknown, it has long been known that the HLA-B27 gene appears at a high frequency in ankylosing spondylitis patients, indicating a genetic factor.
ViGenCell explained that its auxiliary diagnostic kit is a lyophilized product containing all reagents necessary to amplify the HLA-B27 gene. It can be transported refrigerated or at room temperature, and its ease of use is an advantage as only the patient's DNA needs to be added.
ViGenCell’s kit is planned to be sold to domestic diagnostic testing centers in the future. Export through CE certification is also planned. Additionally, lyophilized products for real-time gene amplification (PCR) kits for auxiliary diagnosis of diseases such as Behcet’s disease and cancer gene testing kits are being researched and developed, with plans to sequentially obtain product approvals.
Choi Hee-baek, head of ViGenCell’s Precision Medical Diagnostics Group, said, "We hope that ViGenCell’s auxiliary diagnostic kit will help in the confirmation and diagnosis of ankylosing spondylitis, where early diagnosis and treatment are important, leading to smooth treatment for patients." He added, "This manufacturing approval and product certification mark the official starting point of our precision medical diagnostics business, and we will strive to sequentially achieve the planned schedules going forward."
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