French diagnostics developer bioMérieux won the FDA's approval for a new device designed to rapidly spot nearly 200 strands of bacteria and yeasts that can cause serious illness. The milestone builds on other U.S. regulatory, research and market victories the company has notched so far this year.
Specifically, the company's Vitek MS mass spectrometer system won the FDA's blessing. In an unusual move, regulators announced the approval themselves, noting the product is the first mass spectrometer system to gain marketing approval in the U.S. for automatic identification of bacteria and yeasts that can make patients quite sick.
"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, director of the FDA's Office of In Vitro Diagnostics and Radiological Health, said in a statement.
Regulators note that Vitek MS is designed to spot Candida, Cryptococcus and Malassezia groups, and bacteria from the Staphylococcaceae, Streptococcaceae, Enterobacteriaceae, Pseudomonadaceae, and Bacteroidaceae families. These can cause a wide variety of conditions, from skin and bloodstream infections to pneumonia and meningitis, and patients with compromised immune systems are at particular risk. The device is able to spot 193 different microorganisms and handle up to 192 different tests in a single automated series of testing, the FDA said (each test takes about a minute).
It's a significant advance for diagnostics in the U.S., because with many of these bacteria and yeast pathogens, quicker detection boosts the chance of successful treatment. The FDA said it based its approval of the company's de novo petition on the results of a study of 7,068 organisms, where VITEX MS spotted the bacteria or yeast scientific group or family correctly 93.6% of the time.
With this approval, bioMérieux is on a roll. In May, the company won approval for its companion diagnostic designed to go with two GlaxoSmithKline ($GSK) melanoma drugs. Earlier this year, bioMérieux subsidiary bioTheranostics generated encouraging results for a new molecular diagnostics test designed to predict the recurrence of prostate cancer. And bioMérieux continued to expand sales during the year in emerging markets.
While bioMérieux is a global company with operations in more than 150 countries, the test is manufactured in Durham, NC, regulators said.
- read the FDA's release
- here's the company's announcement