Bodytechmed Completes Domestic Approval for 6 Types of Thyroid Diagnosis Kits

AFIAS-10 device and three diagnostic kits (left) from Boditech Med, and iChroma-3 device and three diagnostic kits Photo by Boditech Med

[Asia Economy Reporter Lee Chunhee] Bodytech Med announced on the 22nd that it has completed domestic approval from the Ministry of Food and Drug Safety for six diagnostic kits that can quickly and accurately check thyroid function.

Thyroid function tests are performed to verify whether the thyroid is functioning properly by measuring the blood concentrations of thyroid-stimulating hormone (TSH) and the hormones produced by the thyroid, T3 and T4.

Bodytech Med has recently been releasing upgraded thyroid function diagnostic kits applying the rapid freezing (Granule, graenul) method one after another. The ichroma T3 was approved domestically in 2020, and the AFIAS T3 product received approval in July last year. This month, approvals for three products?ichroma TSH, AFIAS TSH, and AFIAS Free T4?were completed, and the approval process for ichroma Free T4 was finalized the day before. 'Free T4' is a form of the hormone T4 produced by the thyroid, accounting for 0.1% of T4 concentration and maintaining a constant level in the body, providing accurate values related to thyroid function.

The main features of the newly released products are the use of whole blood, point-of-care testing, and application of the granule method. Currently, diagnostic products used domestically require patients to visit hospitals for venous blood collection, which is then transported to central laboratories equipped with testing devices, or in the case of general internal medicine, samples are sent to outsourced institutions, resulting in several days before obtaining test results. Bodytech Med’s products use small devices (ichroma/AFIAS two types) to provide test results within 12 minutes on-site using whole blood. Additionally, since the antibodies in the buffer solution are manufactured using the granule method, the products can be shipped and stored at room temperature while maintaining stable performance.

According to the annual insurance claim data from the Health Insurance Review and Assessment Service, the domestic diagnostic market size for thyroid function tests is known to exceed 25 million cases per year. Currently, the market share is split roughly 50% between large hospitals and local clinics such as neighborhood internal medicine clinics, with the local market mostly relying on outsourced institutions for test results. The company emphasized, "Despite showing performance equivalent to major competitors’ products, our products can quickly provide test results within 12 minutes at the patient’s location using whole blood," adding, "Bodytech Med’s products offer solutions that enable same-day diagnosis and same-day prescription."

Choi Eui-yeol, CEO of Bodytech Med, stated, “With the approval process for the Free T4 product completed, we can say that the thyroid function diagnostic solution is now complete,” and added, “We are confident that this diagnostic solution, which combines high accuracy with point-of-care testing capability, will bring significant changes to the domestic thyroid function diagnostic market.”