BD gets 510(k) for viral gastroenteritis diagnostic
- Medtech manufacturer Becton, Dickinson and Company said Thursday the FDA granted 510(k) clearance to a molecular diagnostic test it developed to detect and differentiate pathogens that cause viral gastroenteritis.
- The enteric viral panel, a version of the BD MAX system, is an automated, targeted diagnostic that distinguishes the root causes of infectious diarrhea symptoms like norovirus, rotavirus, adenovirus, human astrovirus and sapovirus.
- BD touted the turnaround time for results — less than 3.5 hours — enabling clinicians to more quickly isolate patients and limit spread of infection.
According to CDC, norovirus is the most common cause of acute gastroenteritis for people of all ages, with 685 million cases worldwide each year, causing nausea, vomiting, diarrhea and in some instances, death. BD also noted that norovirus accounts for 50% of all foodborne diarrheal outbreaks.
Norovirus and other gastrointestinal illnesses commonly cause highly contagious outbreaks everywhere from daycare centers and nursing homes, to cruise ships and college campuses.
In addition to helping isolate patients, BD said that its diagnostic is useful for ruling out other causes of infection in children, the elderly or immunocompromised patients. BD said its panel performs nucleic acid extraction and real-time PCR, and most assays can be tested within three hours. Other BD MAX variations include tests for sexually transmitted infections.
BD's diagnostic systems business, under its Life Sciences division, has seen a nearly 10% jump in revenue growth over the last year. Other companies with norovirus diagnostics in their portfolios include Abbott, QIAGEN and bioMérieux.