Meridian Mycoplasma Pneumonia Test 510(k) Cleared

FDA has cleared a Meridian Bioscience 510(k) for a new molecular diagnostic test for Mycoplasma pneumonia. The Illumigene Mycoplasma Direct assay features a simplified three-step procedure that provides definitive results in less than one hour, the company says. Often referred to as “walking pneumonia,” M. pneumoniae is associated with up to 40% of community-acquired pneumonias and accounts for about two million infections annually in the U.S., it says.

The Illumigene Mycoplasma Direct “accurately detects infection on the first day of symptoms and provides the ability to avoid treating patients empirically to reduce the administration of broad spectrum antibiotics and the likelihood of antimicrobial resistance,” Meridian says. It uses throat swabs and samples are in process in less than two minutes of hands-on time. The Illumigene molecular assays also test for C. difficile, Group A Streptococcus, Group B Streptococcus, HSV 1 and 2, and Pertussis.