Boditech Med has announced that Boditech Med achieved the export license of two types of diagnostic kits (ichroma™/AFIAS Vitamin D Neo) from the Korean Ministry of Food and Drug Safety. The ichorma™/AFIAS Vitamin D Neo can determine the Vitamin-D level with whole blood sample in 12 minutes on the spot.
Most of Vitamin D monitoring has been processed by commercial reference lab. With the launch of new ichroma / AFIAS Vitamin D Neo enable patients to get the test results in 12 minutes on the spot. It is expected that these products will be useful for the local hospitals and clinics. The approval process for a domestic license is currently in progress through the Ministry of Food and Drug Safety. Boditech Med has been striving to get approval by end of the second quarter of 2022.
Vitamin D manages to keep balance between calcium and phosphorus homeostasis in blood in the normal range and regulates the usage of calcium and phosphorus, to make the main components of bones. Vitamin D deficiency could weaken the bone structure and cause the risk of osteoporosis in adults. It also could inhibit the bone growth in children and adolescents.
According to data from the Korean National Health Insurance Corporation, Vitamin D deficiency patients groups are around 48% of the total population, and the percentage is increasing every year. Recently, as outside activities are restricted due to the impact of the COVID-19 pandemic, the number of patients with vitamin D deficiency is increasing.
Since 2016, Boditech Med has launched Vitamin D test kits that can detect Vitamin D deficiency and has been selling all over the world. Since its launch, it generated an average annual sales growth of more than 60% is considered one of the top five best selling products of Boditech Med along with D-Dimer, which is used as a predictive biomarker for heart disease in 2021, and CRP for diagnosing systemic inflammation.
The ichorma™/AFIAS Vitamin D Neo are well received in in-vitro diagnostic market as the products overcome the shortcomings of existing products and accelerate the popularization of Vitamin D test. Especially, the test time has been greatly reduced from 30 minutes to 12 minutes, and it is a product that maximizes the advantages of point-of-care testing (POCT) by extending the sample from the existing serum and plasma to whole blood that does not require a separate centrifugation process.
Boditech Med acquired the Vitamin D Standardization Certification Program (VDSCP) hosted by the Centers for Disease Control and Prevention (CDC). Through this certification program, the CDC is improving the analytical accuracy and reliability of vitamin D testing worldwide. Currently, there are 56 clinical institutions and manufacturers worldwide that have acquired VDSCP certification, and Boditech Med is the only manufacturer in South Korea. Boditech Med is planning to get the certification of the ichorma™/AFIAS Vitamin D Neo by the first half of this year.
A company official said, “It is expected that our ichorma™/AFIAS Vitamin D Neo will bring a significant change in enzyme-immune diagnostic market, which is dominated by existing full automated laboratory devices, as it takes only 12 mins to get a result with whole blood sample. We are also planning to get domestic license of ichorma™/AFIAS Vitamin D Neo by the second quarter of 2022. After getting the approval process, we believe that these products will create a synergetic effect with the rapid COVID-19 antigen test kit, which is currently being sold through domestic hospitals and hospitals.”