FDA OKs Multipathogen Nucleic Acid Test for CNS Infections

  • FDA,Multipathogen Nucleic Acid,CNS
  • medscape

The US Food and Drug Administration (FDA) today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous system (CNS) infections.

The FilmArray Meningitis/Encephalitis (ME) Panel (BioFire Diagnostics) is designed to test CSF specimens from patients who have signs and symptoms of these two conditions. The test can yield results in about 60 minutes. In contrast, it may take up to 3 days to identify a bacterial infection using current diagnostic technology, according to an FDA news release. The wait time for viral infections can be longer, given that specimens often must be shipped to specialized laboratories.

The quicker turnaround with the FilmArray ME Panel, the agency said, "may enable clinicians to make informed treatment decisions earlier."

The FilmArray ME Panel uses a small CSF sample. "Currently, testing CSF for multiple organisms is not always possible because it can be difficult to obtain enough fluid from each patient to run multiple tests," the FDA said.

The new test identifies the following pathogens:

Bacteria and yeast

  • Escherichia coli K1

  • Haemophilus influenzae

  • Listeria monocytogenes

  • Neisseria meningitidis

  • Streptococcus agalactiae

  • Streptococcus pneumoniae

  • Cryptococcus neoformans/gattii

Viruses

  • Cytomegalovirus

  • Enterovirus

  • Herpes simplex virus 1

  • Herpes simplex virus 2

  • Human herpesvirus 6

  • Human parechovirus

  • Varicella zoster virus

The FDA cautions that the FilmArray ME Panel does not identify all causes of CNS infections or pinpoint which antimicrobial drug may work the best against a bacterial kind. Accordingly, clinicians should still perform standard CSF bacterial and fungal cultures because the new test can produce false negatives and false positives. In addition, bacterial growth is needed for drug susceptibility testing in the case of positive results.

In a prospective study of CSF samples taken from 1560 patients with suspected meningitis or encephalitis, there was "high agreement" between the results from the FilmArray ME Panel and those from other test methods, including culture. The new test also proved accurate in identifying pathogens already known to exist in other CSF samples.

More information on todays announcement is available on the FDA website.


This link:http://www.chemcd.com/news/18904.html

The ChemCD compiler finishing, shall not be reproduced without permission, for reprint please indicate the source。

comments powered by Disqus

Categories

Related News

FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim's Basaglar™

2014/08/19 - The FDA today granted tentative approval for Basaglar? (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes.

FDA Approves Pembrolizumab for Advanced Melanoma

2014/09/05 - Today the FDA approved Keytruda (pembrolizumab), a new treatment for advanced melanoma, the deadliest form of skin cancer. Melanoma patients have been waiting anxiously for this day, given the promising data that early studies have shown.

FDA reviewers say Pfizer's Chantix should keep its black box

2014/10/20 - FDA staffers aren't as impressed with new safety data on Chantix as Pfizer ($PFE) wants them to be. In briefing documents filed in advance of Thursday's advisory committee meeting, reviewers say the stop-smoking remedy should keep its black-box warning about potential psychiatric side effects.

Otsuka wins early FDA approval for a colorectal cancer combo drug

2015/09/23 - Japanese drugmaker Otsuka won FDA approval for a two-drug therapy for colorectal cancer, planning to market the combination as a treatment for advanced forms of the disease.

FDA approves Flonase allergy relief for sale over-the-counter in the United States

2014/07/26 - GlaxoSmithKline plc today announced that the U.S. Food and Drug Administration (FDA) has approved Flonase? Allergy Relief containing the No. 1

Sanofi and Regeneron Announce Sarilumab Biologics License Application Accepted for Review by US FDA

2016/01/11 - Sanofi and Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab.