NEW YORK (360Dx) – Becton Dickinson said today that the US Food and Drug Administration has granted 510(k) clearance for its BD Max enteric viral panel, a molecular diagnostic test for the detection and differentiation of pathogens that cause viral gastroenteritis.
The BD Max enteric panel detects the viral cause of infectious diarrhea symptoms, including norovirus, rotavirus, adenovirus, human astrovirus, and sapovirus, in all care settings, the firm said.
The panel can return results in less than 3.5 hours, shortening time to results over traditional test methods and allowing clinicians to more quickly understand the cause of the patient's illness, BD said.
Acute viral gastroenteritis can be contracted by virtually any patient and spread within close community settings such as daycare centers, nursing facilities, and cruise ships. Norovirus is the most common viral cause and accounts for 19 to 21 million cases of diarrheal illness annually in the US and 50 percent of all foodborne diarrheal outbreaks.
The firm's launch of the enteric viral panel and "suite of assays for diagnosing gastrointestinal conditions will provide clinicians with greater flexibility for more efficient and cost-effective patient management," Nikos Pavlidis, vice president and general manager of molecular diagnostics and women's health for BD, said in a statement.
BD said that its enteric suite of molecular tests for the detection of gastrointestinal bacteria, parasitic, or viral pathogens enable clinicians to perform targeted testing for patients based on their symptoms, health history, or exposure.
Its enteric panels run on the BD Max system — a fully integrated, automated molecular diagnostics platform that performs nucleic acid extraction and real-time PCR.
At the European Congress of Clinical Microbiology and Infectious Diseases earlier this year, BD introduced its first new molecular testing platform in several years, the BD Cor, a fully automated high-throughput, real-time PCR testing system expected to launch next year in Europe and compete with the likes of similar platforms offered by Roche, Abbott, and Hologic.