Good News in the Fight Against Blood Stream Infections: Bacterial Test Approved by FDA

July 8, 2012

The Food and Drug Administration (FDA) has recently allowed the marketing of the first nucleic acid test that can identify 12 different bacterial pathogens known to cause bloodstream infections.

Bloodstream infections are a common and serious illness occurring in the U.S. hospitals.  They result when bacteria enter the patient’s bloodstream, and can cause severe illness by infecting the patient’s heart, kidneys, and other vital organs.  Without effective treatment, bloodstream infections can result in serious illness, including death.

The newly approved test is called the Gram-Positive Blood Culture Nucleic Acid Test (BC-GP).  The test has been shown to identify several different types of bacteria, including the following problematic types:

  • Staphylococcus (including methicillin-resistant Staphylococcus aureus (MRSA),
  • Streptococcus,
  • Enterococcus (including vancomycin-resistant Enterococci (VRE), and
  • Listeria.

In the fight against bloodstream infections, this is very good news.  Bloodstream infections have to be treated with antimicrobial drugs.  Thus, it’s important to be able to quickly determine which drug is appropriate for the patient based on the type of pathogen causing the infection.  The BC-GP test allows the identification of the bacteria causing the infection within hours after a positive blood culture.  This gives providers the ability to prescribe the appropriate medication quickly.

The test is manufactured by Nanosphere.

Click here to read the FDA News Release.

Click here to visit the Nan0sphere website.

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