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The world's first entecavir companion diagnosis system approved by the…

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작성일 14-04-14 13:29


GeneMatrix cited the announcement from the Ministry of Health and Welfare, and the Hepatitis B Entecavir drug resistance diagnostic agent, which adopted its original RFMP molecular diagnostic technology, was finally listed as a new medical technology (Ministry of Health and Welfare Notification No. That’s it. With this new medical technology license, GeneMatrix's'Hepbiter-Entecavir' products can be sold directly to the medical field.

Entecavir (product name; Baracrude Tablet) is the primary treatment for chronic hepatitis B, and recorded an outpatient prescription amount of about 150 billion won in 2012, ranking the first in sales of a single drug. It is a new blockbuster hepatitis B drug.

If entecavir drug resistance develops, the treatment effect decreases significantly. Therefore, effective hepatitis B treatment is possible only after confirming the presence or absence of resistance. Through the'Hepbiter-Entecavir' licensed this time, it is possible to determine whether to continue the medication and whether to replace or merge other drugs by finding out the genetic variation that causes entecavir's resistance. 'Hepvita Type-Entecavir' is the world's first companion diagnostics for entecavir, and the companion diagnostics are administered for the purpose of diagnosing the therapeutic response or resistance of the treatment to maximize the therapeutic effect of the drug or minimize side effects. It is a diagnostic product that is used in combination with.

According to a notice from the Ministry of Health and Welfare, the hepatitis B entecavir drug resistance diagnostic method was evaluated as a valid test with high accuracy in detecting mutations compared to the nucleotide sequence test. In addition, clinical efficacy has been verified through multi-center clinical institutions, and these clinical results have been published in about 10 SCI international papers including Antiviral Therapy, an internationally renowned antiviral therapy journal.

With this new medical technology registration, the era of customized treatment for hepatitis B has become possible, and we will continue to strive to develop new-concept diagnostic products that can monitor drug treatment effects, thereby contributing to the improvement of overall treatment effectiveness and national health finance efficiency.