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FDA Clears Meridian Bioscience's Updated Mycoplasma Pneumoniae Test

NEW YORK (GenomeWeb) – Meridian Bioscience announced today it has received clearance from the US Food and Drug Administration for a Mycoplasma pneumoniae test.

The illumigene Mycoplasma Direct assay was launched in Europe earlier this year. It features a three-step procedure that eliminates the need for specialized techniques and training, the firm said in a statement, and is an improved version of a test that was cleared by the FDA in 2013.

The assay uses throat swabs and requires less than two minutes of hands-on time, Meridian noted.

"As the market share leader for Mycoplasma pneumoniae testing, we are pleased to be able to offer our customers an improved molecular assay for Mycoplasma pneumoniae," Mike Shaughnessy, vice president of Meridian and president of Meridian Global Diagnostics, said in a statement. He added that the firm's illumigene molecular diagnostics platform "does not require cumbersome capital equipment or costly hidden service contracts," and that the firm is now able to address a larger customer base to improve patient care.

M. pneumonia, or "walking pneumonia," is thought to account for 40 percent of community-acquired pneumonia cases, and there are about 2 million infections each year in the US, Meridian said. Typical antibiotics like penicillin and cephalosporins are ineffective against Mycoplasma bacteria because this genus lacks a cell wall. Detection of M. pneumonia with a molecular test can be achieved on the first day of symptoms, and could prevent empirical use of antibiotics, the company said.

Meridian's test menu on the illumigene platform also includes FDA-cleared assays for Clostridium difficileGroup A StrepGroup B Strep, Bordetella pertussis, and herpes simplex virus 1 and 2, with CE-marked assays for chlamydia, gonorrhea, and malaria available outside of the US.