Taiwan's Enimmune could reduce reliance on imported dengue combo tests
台灣的安特羅生技公司（Enimmune）可望減少對進口登革熱二合一檢測試劑的依賴。
| TAIPEI (Taiwan News) — Enimmune said Monday it has completed local clinical specimen testing for its dengue antigen–antibody combo rapid test, with results showing high accuracy and low false-positive and false-negative rates.
The company said it plans to submit an application to Taiwan’s Food and Drug Administration on Monday for approval as a Class 2 domestically manufactured medical device. If approved, the product would be the only domestically developed dengue antigen–antibody combo rapid test on the local market, according to UDN. Dengue is one of the world’s most common mosquito-borne viral infections. According to the World Health Organization, about 3.9 billion people in more than 100 countries are at risk of infection, with roughly 75% living in the Asia-Pacific region. There are currently three main types of dengue rapid tests. NS1 (nonstructural protein 1) antigen tests detect a protein produced by the dengue virus in the early stage of infection, while IgG and IgM (immunoglobulin G and M) antibody tests detect the body’s immune response. Combination tests, like Enimmune’s, detect both at the same time. In Taiwan, only two imported products offer this format. By detecting both viral antigens and antibodies in a single test, the kit can help doctors quickly identify possible dengue infections. Enimmune said it expects to receive regulatory approval before the end of the year. In addition to strengthening Taiwan’s disease response capabilities and supporting domestic medical manufacturing, the company said it aims to enter Southeast Asia’s dengue testing market, which it estimates is worth up to NT$3.16 billion (US$100 million). The company said the product was evaluated using clinical specimens at a Biosafety Level 3 laboratory at National Cheng Kung University Hospital under a National Science and Technology Council core facility platform. |
|
| Charlotte Lee Taiwan News, Staff Writer | |
| 2026-03-02 |
