Neogen's Rapid Test For Salmonella Enteritidis Receives FDA Approval

Main Category: Infectious Diseases / Bacteria / Viruses
Also Included In: GastroIntestinal / Gastroenterology;  Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 13 Jan 2011 - 2:00 PDT


Neogen Corporation (Nasdaq: NEOG) announced that its rapid test for Salmonella enteritidis (SE) has been determined by the U.S. Food and Drug Administration (FDA) to be equivalent to the FDA's traditional testing method in accuracy, precision, and sensitivity for detecting SE.

The FDA's determination of equivalency will allow egg producers and processors to use Neogen's Reveal for SE to shorten the testing time and comply with the FDA's recently implemented SE-regulations without further scrutiny. In November, the AOAC International validated the accuracy of the Reveal for SE system when testing either environmental or egg samples.

"The FDA's determination of equivalency further validates our test as an invaluable tool to egg producers, as they comply with the FDA's new regulations, and seek to further reduce the likelihood of SE-contaminated eggs reaching consumers," said Ed Bradley, Neogen's vice president of Food Safety. "Until our introduction of an effective rapid test for SE, the industry had to wait up to 7 days for an outside laboratory's test results. Reveal for SE enables the industry to get quicker results and provides the accurate answer they need to manage their flocks and egg production."

Neogen, in cooperation with USDA scientists, began the development of this test in 2000.

"Using a rapid test for SE that uses the same sample enrichment protocol as the FDA not only allows analysts to quickly screen out negative test results, but also is compatible with the FDA confirmation process by using the same enriched samples," said Bradley. "Especially now, with the heightened concern for contaminated eggs, time is of the essence."

The foodborne illness caused by SE is generally due to eating raw, incompletely cooked, or recontaminated eggs. Ingestion of SE-contaminated poultry meat is the second leading cause of this illness.

Source: Neogen Corporation

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