FDA approves novel mass spectrometer

FDA approves novel mass spectrometer
FDA approves novel mass spectrometer

HealthDay News -- The FDA has approved a novel mass spectrometer system designed to identify 193 yeast and bacteria that are capable of causing pneumonia, meningitis and skin and bloodstream infections.

The automated system, VITEK MS (bioMerieux Inc.), can perform as many as 192 different tests in a single automated series, with each test taking about one minute, the agency said in a press release.

“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,” said Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health. “Rapid identification of harmful microorganisms can improve the care of critically ill patients.” 

The mass spectrometer is able to identify yeasts such as those from the Candida, Cryptococcus and Malassezia groups, and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae and Bacteroidaceae families.

People with AIDS and others with weakened immune systems, such as patients undergoing cancer treatment or anti-rejection therapy following an organ, are most prone to infections from these germs.

The device uses a laser to break germs into pattern-forming particles that are unique to each yeast or bacterium and then compares the pattern with those stored in the system's database to identify the microorganism, the FDA said.

Mass spectrometry requires only a small amount of yeast or bacterial growth, so testing can start as soon as growth is visible, generally within 18 to 24 hours. This is much quicker than traditional methods, which take up to five days to produce the same identification results.

In clinical testing involving 7,068 microorganisms, the new device correctly identified a germ's scientific group or family more than 93% of the time (with 87.5% of microorganisms identified to species level) compared with sequencing and biochemical testing, the agency said.

The spectrometer yielded a "no identification" result for 3.2% of microorganisms included in the study. Just 0.8% were incorrectly identified. 

The FDA approved VITEK MS using its de novo classifcation process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

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