Updates

New Test System Identifies 193 Different Yeasts & Bacteria Known to Cause Illness

The U.S. Food and Drug Administration today allowed marketing in the U.S. of the first mass spectrometer system for automatedentification of bacteria and yeasts that are known to cause serious illness in humans. The VITEK MS canentify 193 different microorganisms and can perform up to 192 different tests in a single automated series of testing, with each test taking about one minute.

The VITEK MS canentify yeasts such as those from the Candida, Cryptococcus and Malassezia groups, and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae, and Bacteroidaceaefamilies, which are associated with skin infections, pneumonia, meningitis, and bloodstream infections. People with immune systems that are compromised or weakened by HIV/AIDS, cancer treatment, or anti-rejection therapy following an organ transplant are particularly vulnerable to these infections.

“The ability for laboratories to use one device toentify almost 200 different microorganisms is a significant advance in the timelyentification of pathogenic microorganisms,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s Center for Devices and Radiological Health. “Rapidentification of harmful microorganisms can improve the care of critically ill patients.”

The VITEK MS incorporates a technology called matrix-assisted laser desorption/ionization–time of flight mass spectrometry (MALDI-TOF MS). The technology uses a laser to break yeast and bacteria specimens into small particles that form a pattern unique to the microorganism. The VITEK MS automatically compares the microorganism pattern to 193 known yeasts and bacteria in the test system’s database toentify the microorganism.

Compared to otherentification methods that require abundant organism growth for testing, 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.  Traditional methods can take up to five days to produce the sameentification results.

The FDA reviewed the VITEK MS through its de novo ification process, a regulatory pathway for some novel low-to-moderate risk medical devices that are not substantially equivalent to an already legally marketed device.

For the de novo petition, the FDA based its decision on the results of a study of 7,068 microorganisms. When compared to sequencing and biochemical testing, the VITEK MS correctlyentified the scientific group or family 93.6 percent of the time (with 87.5 percent of microorganismsentified to species level). The VITEK MS provided a `‘noentification’` result for 3.2 percent of the microorganisms in the study. Of all test results, only 0.8 percent were incorrect and 2.4 percent were low discrimination with no correct result.

The VITEK MS is for clinical use for theentification of microorganisms cultured from human specimens. It is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

The VITEK MS is manufactured by bioMerieux, Inc. in Durham, N.C.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

For more information, contact: Media Inquiries Susan Laine Phone: 301-796-5349 Email: susan.laine@fda.hhs.gov

Consumer Inquiries Phone: 888-INFO-FDA Email: dsmica@fda.hhs.gov