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FDA clears Cepheid’s Xpert GI panel for pathogen detection

Cepheid has received clearance from the US Food and Drug Administration (FDA) for its Xpert GI Panel, a multiplex polymerase chain reaction (PCR) gastrointestinal (GI) pathogen testing solution. The ...
National Institute for Health and Care Excellence

Integrated multiplex PCR tests for identifying gastrointestinal pathogens in people with suspected gastroenteritis (xTAG Gastrointestinal Pathogen Panel, FilmArray GI Panel and ...

July 2022: The guidance has been withdrawn because PCR tests now form part of standard care. Since the diagnostics guidance was published, expert advice suggests that clinical practice has moved on; ...
Business Wire

Applied BioCode Submits 510(k) Application to FDA for BioCode MDx-3000 with Gastrointestinal Pathogen Panel

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode announced today that it has submitted the BioCode MDx-3000 with 18-Plex Gastrointestinal Pathogen Panel (GPP) to the U.S. Food and Drug ...
Healio

FDA-cleared GI test detects ‘most likely causes’ of diarrheal syndromes

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. The test aids in detecting eight bacteria, two parasites ...
Business Insider

QIAGEN expands QIAstat-Dx syndromic testing menu in the U.S. with launch of molecular test to improve gastrointestinal care

Germantown, Maryland, and Venlo, the Netherlands, June 03, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the QIAstat-Dx Gastrointestinal ...
Nature

Infectious Diarrhea and Gastrointestinal Pathogen Detection

The burden of infectious diarrhoea remains a significant global health challenge, compounded by the diverse array of gastrointestinal pathogens including bacteria, viruses and parasites. Advances in ...
Business Wire

QIAGEN secures U.S. clearance for first QIAstat-Dx mini gastrointestinal panel to support year-round outpatient care

GERMANTOWN, Md., & VENLO, The Netherlands--(BUSINESS WIRE)--QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. regulatory clearance of the first in a series of QIAstat-Dx ...