The rapid diagnostic test, "CareStart™ Flu A&B Plus," which has been approved by the US FDA, is a product that can detect influenza type A and B by immunochromatography after taking samples of patients with flu symptoms. It is a field diagnosis product that quickly determines an infection within 10 minutes.
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According to the Centers for Disease Control and Prevention (CDC), from last winter to February, the number of deaths in the United States from the flu has exceeded 12,000. With the mounting criticism and concern over the spread of flu each year, the demand for flu diagnosis is also overgrowing.
Access Bio sated, "It took a lot of time to get the final permission as the licensing standards, including the US FDA's mandatory performance requirements, have been tightened for effective flu virus control. It also means that market entry barriers have increased, and thus high entry barriers will be a positive factor for the market expansion of Access Bio."
Also, "Through the US FDA 510(k) Clearance, we can sell the diagnostic test not only to the US but also to Canada. In the case of Europe, the approval from the US FDA can be used as a reference, so it is expected to make it easier to secure sales channels."
Access Bio plans to diversify its sales structure from Africa to advanced countries such as the US, Canada, and Europe with its flu diagnosis test.
