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Bionote, an in vitro diagnostic product manufacturer, announced they have completed the Japanses MAFF approval process for their 'Vcheck SDMA' kit, which is used for early screening of decreased kidney function in companion animals. Through this approval, it has become possible for Bionote to sell the 'Vcheck SDMA' kits in Japan, and Bionote has announced they will start providing it through their local Japanese partners.
SDMA (Symmetric Dimethylarginine), is a amino acid that is produced during the process of breaking down proteins in the body and 90% of it is filtered by the kidney. If the kidney is not functioning properly, the SDMA does not get filtered out of the system and remains in the body. An IVD kit can be used to measure the SDMA levels in the body to screen for decreased kidney function and SDMA has less interfering factors than traditional biomarkers, with SDMA levels increasing after only 25 - 40% of damage to the kidneys.
Traditional biomarkers that are used to test for kidney function, such as creatinine, is affected by factors such as whether the cat or dog in question has a lot of muscle mass and only starts to increase after around 75% of the kidney has been damaged. As such, in recent years, SDMA tests have been used more frequently for early screening of chronic kidney diseases, according to Bionote.
Bionote's 'Vcheck SDMA' diagnostic kit quantitavely measures the SDMA amount in samples, using an analyzer called Vcheck F V200, quickly and with ease. Bionote also explained that when the Vcheck SDMA results were compared with lab tests, 98% of the results were in agreement. The kit only requires 100 microliters of serum or plasma (heparin) samples and the results can be confirmed after only 11 minutes, said the Bionote spokesperson.
CEO of Bionote, Dr. Byung Ki Cho, said that "it has become possible for us to sell our Vcheck SDMA in Japan through this approval and registration" and that "We expect to be able to provide this product to over 3,000 animal hospitals in Japan from 2023 onwards". Bionote is currently in the process of going public in KOSPI through NH Investment & Securities and Korea Investment & Securities, at the end of the year.