MONDAY, SEPTEMBER 26, 2016

FDA approves marketing for system that tests yeasts and bacteria

The U.S. Food and Drug Administration announced on Wednesday that it will allow U.S. marketing of the first mass spectrometer system that automatically identifies illness-causing bacteria and yeasts.

The VITEK MS is able to identify 193 different microorganisms and can conduct as many as 192 different tests in one automated series of testing. Each test takes approximately one minute to conduct.

The device is able to identify yeasts from the Malassezia, Cryptococcus and Candida groups, and bacteria from the Bacteroidaceae, Pseudomonadaceae, Enterobacteriaceae, Streptococcaceae and Staphylococcaceae families. Such yeasts and bacteria cause skin infections, bloodstream infections, meningitis and pneumonia. Immune compromised individuals are especially vulnerable to the infections.

"The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms," Alberto Gutierrez, the director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health, said. "Rapid identification of harmful microorganisms can improve the care of critically ill patients."

The VITEK MS uses a technology called matrix-assisted laser desorption/ionization - time of flight mass spectrometry to break bacteria and yeast specimens into small particles and identify a unique pattern in each microorganism. While traditional testing methods can take up to five days to produce similar identification results, the VITEK MS takes between 18 and 24 hours.

The VITEK MS is manufactured by the Durham, N.C.-based bioMerieux, Inc.