DiaSorin Receives 510(k) Clearance for Blood Test Device

Italy-based DiaSorin has received 510(k) clearance from the FDA for its Liaison MeMed BV immunoassay that differentiates between bacterial and viral infections.

Rather than trying to identify pathogens directly, the test assesses the immune response to a viral or bacterial infection, enabling healthcare providers to make informed treatment decisions.

Current practices such as medical history, physical findings and other medical tests provide incomplete answers, especially when the infection site is inaccessible, the company said.

DiaSorin gained the rights to commercialize the test for use on its Liaison analyzer platform in the U.S. in a September 2020 licensing deal with MeMed.