(Alliance News) - DiaSorin Spa reported Wednesday that it has received 510(k) clearance from the U.S. Food and Drug Administration for the new Liaison Plex Yeast Blood Culture Assay, the second multiplexing molecular diagnostic panel on Liaison Plex analyzer-

The Liaison Plex Yeast Blood Culture Assay represents the first of three panels for diagnosing blood infections on the group's new mutiplexing platform and enables the identification of 16 pathogens commonly associated with fungemias. Fungal pathogens are often considered an emerging threat and are of great concern because of their easy spread among patients in healthcare facilities.

"The clearance received today from the FDA is further testimony to the importance of the new Liaison Plex analyzer," commented Angelo Rago, president of Luminex.

"The Yeast Blood Culture Assay panel adds to our existing solution for the diagnosis of blood infections, in which we are a market leader, by providing a rapid solution for this critical clinical condition. Through the use of our Liaison Plex analyzer, clinical laboratories and the U.S. healthcare system will be able to meet their diagnostic and antimicrobial stewardship needs for better patient outcomes."

The Liaison Plex is a fully automated, easy-to-use and "sample-to-answer" system, has a simplified workflow and uses room-temperature consumables. Moreover, test preparation time is only two minutes per sample, and results are produced in less than two hours.

"The approval of the Liaison Plex Yeast Blood Culture Assay represents another strategic milestone for Diasorin as it strengthens its position in the expanding field of multiplexing molecular diagnostics," commented Carlo Rosa, CEO of Diasorin.

"We are strongly committed to continuing to expand our multiplexing offering on the new Liaison Plex platform we have just launched, which will enable laboratories to adopt this cutting-edge technology with the innovative flex cost system, paying only for the targets that really need to be analyzed."

By Giuseppe Fabio Ciccomascolo, Alliance News senior reporter

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