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The First SCF Nucleic Acid-Based Test For The Detection of Multiple Pathogens, Has Been Approved By The FDA

The FilmArray ME panel uses CSF secimens from patients who have signs of meningitis or encephalitis.

“Bacteria and yeast pathogens identified by the FilmArray ME Panel are Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Streptococcus agalactiae, Streptococcus pneumoniae and Cryptococcus neoformans/gattii. Viruses identified by the FilmArray ME Panel are Cytomegalovirus, Enterovirus, Herpes simplex virus 1, Herpes simplex virus 2, Human herpesvirus 6, Human parechovirus, and Varicella zoster virus.”

“Testing one sample for many pathogens and potentially having test results sooner should allow physicians to use this information, along with other clinical findings and test results, to provide improved diagnosis and treatment for these very serious illnesses,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA’s Center for Devices and Radiological Health.

Source: http://www.news-medical.net/news/20151012/FDA-permits-marketing-of-first-CSF-nucleic-acid-based-test-for-detection-of-multiple-pathogens.aspx

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