Access Bio Flu Diagnostic Kit Obtains US FDA Sales Approval

Responding to Rapidly Increasing Flu Diagnosis Demand in the US
Expanding Market Beyond Africa to Advanced Countries like the US, Canada, and Europe

Provided by Access Bio

[Asia Economy Reporter Minwoo Lee] Access Bio's flu diagnostic kit has obtained sales approval from the U.S. Food and Drug Administration (FDA).

Access Bio announced on the 24th that it has received final marketing approval from the U.S. FDA for the 'CareStartTM Flu A&B Plus Rapid Diagnostic Kit.' This product collects specimens from patients showing flu symptoms and detects influenza types A and B using the immunochromatography method. It is a point-of-care diagnostic product that quickly determines infection status within 10 minutes.

Through this, the company plans to respond to the rapidly increasing demand for flu diagnosis in the United States. According to the U.S. Centers for Disease Control and Prevention (CDC), the number of deaths due to flu in the U.S. has exceeded 12,000 since last winter. According to a Grand View Research report, the global flu market is estimated to grow from $1.9 billion (approximately 2.3 trillion KRW) in 2015 to $3.3 billion by 2024. Among these, the U.S. market accounted for the largest share at $500 million (based on 2014).

An Access Bio official stated, "To efficiently control the spread of the flu virus, the U.S. FDA has strengthened approval standards, including essential performance requirements for flu diagnostic products," adding, "As market entry barriers have increased, obtaining this sales approval will act as a positive factor for Access Bio's market expansion."

The company also plans to accelerate entry into other countries besides the U.S. Since it has obtained U.S. FDA sales approval, sales in Canada are also possible, and it can emphasize that the product is FDA-approved in the European region. Access Bio intends to diversify its sales structure, which is currently centered on Africa, to advanced countries such as the U.S., Canada, and Europe through this.