BD Diagnostics said Monday that its BD MAX Enteric Parasite Panel was awarded the CE Mark. The panel — designed for use with the BD MAX System in the treatment of infectious gastroenteritis — will be available throughout Europe beginning in June, said Doug White, vice president and general manager of Molecular Diagnostics and Women’s Health.
The BD MAX Enteric Parasite Panel is a qualitative in vitro diagnostic test that detects DNA from Giardia lamblia, Cryptosporidium (C. hominis and C. parvum) and Entamoeba histolytica in 10% formalin-fixed and unpreserved stool specimens. These pathogens represent commonly isolated and highly pathogenic organisms, White said.
According to BD, the panel is fully automated, rapid and accurate, performing sample preparation, extraction, amplification and detection. Results from the test are available in about four hours and can be used to replace complex, labor-intensive methods such as microscopy and immunoassay, which can take two or more days to identify pathogens, the company said.
The panel is not yet available in the U.S. White said the company is completing clinical trials and plans to submit a 510(k) notification to the FDA shortly thereafter.
Other BD MAX enteric panels are in development and, based upon their progress, BD Diagnostics will move to external validation and clinical trials, White said. — Kellen Owings
Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.