BD Molecular Diagnostics

Enteric pathogens causing diarrhea account for more than 2 million deaths annually.

Globally, there are 1.7 billion cases of diarrhea accounting for more than 2 million deaths annually. Children less than 5 years of age are particularly at risk with 760,000 deaths each year.1 In the U.S. there are greater than 375 million episodes of diarrhea resulting in 900,000 hospitalizations and 6000 deaths annually.2

Current stool culture based testing for enteric pathogens is complex and time consuming. Immunoassay methods are available for some but not all of the major bacterial pathogens and therefore do not alleviate the burden of culture. The majority (>90%)3 of cultures are negative and take at least 2-3 days before results are reported.

In addition to creating a large burden for the laboratory, this greatly complicates patient management since specific causative agents are not identified when a patient is first seen by a physician.

The BD MAX™ Enteric solutions aim to significantly reduce materials and labor for the stool bench by offering a broad menu of enteric pathogen panels and greatly decreasing the time to result of a broad range of enteric pathogens. The BD MAX™ Enteric solutions aim to significantly increase diagnostic accuracy for these enteric pathogens compared to most conventional methods.

Studies:

 

BD MAX™ System Enteric pipeline:

  • Enteric Bacterial Panel: Salmonella spp., Campylobacter spp. (jejuni / coli), Shigellosis disease causing agents [Shigella spp. and Enteroinvasive E. coli (EIEC)] as well as Shiga-toxin producing E. coli 
    • Addresses approximately 95% of bacterial organisms causing infectious gastroenteritis – FDA Cleared 5-6-2014
  • Enteric Parasite Panel*: Giardia lamblia, Cryptosporidium (parvum and hominis), Entamoeba histolytica
    • Can be used in conjunction with EBP or as a standalone assay.
    • Flexible panel options for molecular testing, potentially improving time-to-result and accuracy;
    • Eliminates labor intensive manual processes. – Available 2014.
  • Enteric Viral Panel**
    • Partner Assay developed by Diagenode SA, Belgium. The primers and probes kit is an automated in vitro diagnostic (IVD) test for the qualitative detection of Norovirus (genogroups I and II) and rotavirus species in stool specimens) – Launched (CE, IVD only)

* Product not launched/under development
** Not available for sale in the U.S.

1. WHO Fact Sheet, April 2013 accessed at http://www.who.int/mediacentre/factsheets/fs330/en/
2. World Gastroenterology Organisation Practice Guideline: Acute Diarrhea, March 2008
3. ASM Poster 2013; Evaluation of costs, technologists time and turn-around times for conventional stool cultures.