DiaSorin Gets FDA Clearance for Test to Differentiate Bacterial, Viral Infections

Original from: 360DX

DiaSorin said Friday it received 501(k) clearance from the US Food and Drug Administration to market its Liaison MeMed BV, a high-throughput immune-response assay that can differentiate between bacterial and viral infections.

The company also announced the commercial launch of the test, which uses a fully automated chemiluminescent immunoassay panel to aid in the diagnosis of infectious diseases. The test measures levels of TRAIL, IP-10, and CRP proteins in patient blood to help physicians rule out bacterial infections.

The results can help physicians target treatments and reduce antibiotic overuse, the company said. Evaluations that rely on medical history, physical findings, and other conventional tests can provide incomplete answers, especially when an infection site is inaccessible. By measuring host-response proteins, the MeMed BV tests complement conventional technologies, according to the firm.

"The test provides significant clinical value that supports accurate and informed decisions for patients, accelerating their recovery," DiaSorin CEO Carlo Rosa said in a statement. "The MeMed BV assay has the potential to support that critical decision of whether a patient may have a bacterial or viral infection, when it is crucial to make a time-sensitive treatment decision."

Saluggia, Italy-based DiaSorin is selling the assay for use on its Liaison XL platforms under a 2020 licensing agreement with Haifa, Israel-based infectious disease test developer MeMed. Under that agreement, MeMed can also sell the test for use on its own platform, the MeMed Key. 

MeMed received 501(k) clearance in September 2021. That previous clearance was based on results of a multicenter blinded clinical evaluation study of more than 1,000 children and adults.

DiaSorin and MeMed gained CE marking for the test in November 2021.

Source: DiaSorin Gets FDA Clearance for Test to Differentiate Bacterial, Viral Infections