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FDA clears molecular test for diarrhea-causing pathogens
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The FDA has granted 510(k) clearance to a new molecular test for detecting most of the harmful intestinal pathogens that cause acute gastroenteritis and infectious diarrhea, the manufacturer announced.
The BD MAX extended enteric bacterial panel is the newest addition to the company’s suite of enteric assays for diagnosing acute gastroenteritis, which includes the BD MAX enteric bacterial panel and the BX MAX enteric parasite panel. The addition will enable individualized testing based on patients’ symptoms and health history, according to a press release.
“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 for BD said in the press release. “The BD MAX system allows the diagnostic laboratory to perform molecular testing in a flexible, automated manner, enabling timely results and more efficient patient management.”
The BD MAX system streamlines sample extraction, amplification and detection on a single system to automate real-time PCR testing, and includes open system capability to automate in-house molecular assays. Syndromic panels for health care associated infections, reproductive and sexually transmitted infections and enteric pathogens are all included on the BD MAX menu, and the product can help lab professionals improve operations and reduce the time it takes to provide results vs. conventional methods, according to the press release.
“Thanks to the continued innovation and extended ability of the BD MAX enteric suite to adapt testing to the patient population, geography and clinical presentation, clinical laboratories are able to focus on what’s truly important — their patients,” Joel Mortensen, PhD, managing director for Mortensen and Associates, LLC, a microbiology and molecular diagnostics consulting firm, said in the press release.
Disclosures: White is employed by BD. Healio Gastroenterology was unable to conform Mortensen’s relevant financial disclosures at the time of publication.