Q-linea’s ASTar Antimicrobial Test Named an FDA Breakthrough Device

Q-linea’s ASTar antimicrobial susceptibility test has received a Breakthrough Device designation from the FDA.

The CE-marked test, which can evaluate how a combination of antibiotics will work against gram-negative bacteria, can be used to support “optimal treatment decisions,” the company said.

The innovative test can analyze so-called fastidious bacteria that are difficult to grow.

The Uppsala, Sweden-based company is planning to submit a 510(k) application to the FDA for the test this spring.