Devices & Diagnostics

Meridian Bioscience gets FDA clearance for Legionnaires’ disease test

Diagnostics company Meridian Bioscience (NASDAQ:VIVO) has received U.S. Food and Drug Administration clearance for a test to detect bacteria commonly associated with Legionnaires’ disease. Legionnaires’ disease is a severe lung inflammation caused by an infection. Cincinnati, Ohio-area Meridian said the test, called TRU Legionella, is an important addition to its respiratory product portfolio. “This new […]

Diagnostics company Meridian Bioscience (NASDAQ:VIVO) has received U.S. Food and Drug Administration clearance for a test to detect bacteria commonly associated with Legionnaires’ disease.

Legionnaires’ disease is a severe lung inflammation caused by an infection.

Cincinnati, Ohio-area Meridian said the test, called TRU Legionella, is an important addition to its respiratory product portfolio.

“This new assay solidifies our position as a leader in rapid, accurate testing methods for infectious disease testing,” CEO Jack Kraeutler said.

Meridian said the bacteria associated with Legionnaires’ disease is implicated in 5 percent to 8 percent of the 4 million to 5 million cases of community-acquired pneumonia per year in the U.S.

In December, Meridian received FDA clearances for tests for C. difficile and group B streptococcus.

sponsored content

A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

[Photo by flickr user Spec-ta-cles]