July 2022: The guidance has been withdrawn because PCR tests now form part of standard care.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; ...

Molecular test reportedly simultaneously detects and identifies 15 pathogens, delivering results in five hours. Luminex’ xTAG Gastrointestinal Pathogen Panel (GPP) has been granted a CE mark in the ...

Background. Molecular syndromic diagnostic panels can enhance pathogen identification in the approximately 2–4 billion episodes of acute gastroenteritis that occur annually worldwide. However, the ...

This briefing describes the regulated use of the technology for the indication specified, in the setting described, and with any other specific equipment referred to. It is the responsibility of ...

Multiplex polymerase chain reaction (PCR) test has demonstrated its superiority in diagnosing gastrointestinal infections and has proved to be a rapid, sensitive and specific alternative to ...

Acute gastroenteritis afflicts adults of all ages, causing significant suffering and inflicting significant costs on the American healthcare system. A new study encompassing nearly 40,000 hospital ...

SANTA FE SPRINGS, Calif.--(BUSINESS WIRE)--Applied BioCode announced that it has received U.S. Food and Drug Administration 510(k) clearance for BioCode Gastrointestinal Pathogen Panel (GPP) with high ...

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 ...

Luminex Corporation has announced that it has received FDA clearance for its xTAG Gastrointestinal Pathogen Panel (GPP), the first comprehensive molecular diagnostic assay that tests for greater than ...

Stool culture is the traditional method for identification of bacterial gastrointestinal (GI) pathogens. Many of these pathogens are fastidious and can be rendered non-viable during transport to the ...