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FDA Approves Enteric Parasite Panel for Detecting Intestinal Parasites
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The FDA has approved the BD MAX Enteric Parasite Panel, the latest in a suite of assays that help to diagnose infectious gastroenteritis; the panel can detect common pathogenic intestinal parasites, the manufacturer announced.
“We continue to expand the BD MAX System menu of unique, clinically relevant panels,” Doug White, vice president and general manager of molecular diagnostics and women's health at BD Life Sciences, said in a press release. “BD’s suite of enteric assays will allow flexibility for specific testing needs based on patient and clinical presentation, enabling more efficient patient management and laboratory processes.”
The BD MAX Enteric Parasite Panel (BD Life Sciences) is a qualitative in vitro diagnostic that can detect DNA from Giardia lamblia, Cryptosporidium (C. hominis and C. parvum) and Entamoeba histolytica in both unpreserved and 10% formalin-fixed stool specimens, according to the release. Combined with the BD MAX Enteric Bacterial Panel, these assays can detect the pathogens that are responsible for up to 95% of the bacteria that cause gastroenteritis via a fully automated, fast and accurate platform, the manufacturer said.
According to the press release, the 1.7 billion global cases of diarrhea causing more than 2 million deaths per year (760,000 deaths per year in children younger than 5), can be caused by viruses, bacteria or parasites that may take 2 to 3 days or more to detect using conventional methods in a clinical laboratory. Giardia and Cryptosporidia, for example, are common, but may be underdiagnosed and under-reported in the U.S.
“The BD MAX assays for Clostridium difficile … and selected enteric bacterial and parasitic pathogens are the first commercial assays for selective, targeted diagnosis of enteric infectious diseases, an approach that is consistent with the recommendations of the American Society of Microbiology and the Infectious Disease Society of America,” Patrick Murray, PhD, senior director of worldwide scientific affairs at BD Diagnostics, said in the press release.
The BD MAX System provides automated sample preparation, extraction, amplification and detection on a single system, which saves time and improves efficiency in laboratories, and also provides simplified and standardized molecular testing to minimize result variability, according to the press release. The system’s full menu includes syndromic panels for health care-associated infections, reproductive and sexually transmitted infections, and enteric pathogens.
“The BD MAX Enteric Parasite Panel addition to the menu will further streamline our workflow, improve turnaround time and free up staff that were previously running [enzyme immunoassay] testing manually,” Annette Monterrubio, microbiology and molecular biology system technical coordinator at St. Luke's Health System in Boise, Idaho, said in the press release. “I believe this will greatly benefit patient care.”
Disclosures: Murray and White report they are employees of BD Life Sciences. Healio Gastroenterology was unable to confirm Monterrubio’s relevant financial disclosures at the time of publication.