USDA Issues No Objection Letter To Neogen’s NeoSeek STEC Detection System

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LANSING — Neogen Corp. (Nasdaq: NEOG) has announced the United States Department of Agriculture’s Food Safety and Inspection Service has issued a letter of no objection for the use of Neogen’s NeoSEEK pathogen DNA detection method to detect Shiga toxin-producing strains of E. coli, known in toxicology as STECs.

The letter of no objection allows the use of the 24-hour NeoSeek STEC system as a confirmatory method for six STEC serogroups (O26, O45, O103, O111, O121, and O145) and states the NeoSeek system is comparable to the reference method, FSIS MLG 5B.02, which can take three or more days to achieve a confirmatory result. This allows companies to use the NeoSeek system to comply with the USDA’s recently implemented regulation that requires the testing of raw beef trim for six new STEC serogroups, in addition to the previously regulated STEC, E. coli O157:H7.

“The letter from the USDA provides further assurance to our customers that our NeoSEEK system performs as designed,” said James Herbert, Neogen’s chairman and CEO. “As worldwide food regulation has evolved to address newly identified threats to our global food supply, such as STECs, Neogen’s test systems have evolved to rapidly and accurately detect those threats. NeoSEEK provides the DNA-definitive test the food industry needs that has been proven to be comparable to the older reference method, yet provides much quicker results.”

Neogen received the USDA’s letter of no objection as a result of extensive studies validating the effectiveness of the NeoSeek system. The NeoSeek  technology uses mass spectrometry-based multiplexing to determine the genetic composition of bacteria in a food sample, and then compares those results with the known genetic makeup of the target E. coli strains to identify and differentiate the target strains. NeoSeek provides confirmatory results directly from the enrichment broth, eliminating the need for single colony isolation and allowing for accuracy while delivering confirmatory results more rapidly.

NeoSeek assays a high number of independent genetic markers to detect and identify pathogens, which provides actionable results much sooner than conventional cultural methods.

Like the better known and widely regulated E. coli O157:H7 strain, these other six E. coli strains are known food safety concerns, and produce Shiga toxins, which are known to cause severe illness.

Neogen develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media, and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in the development of animal genomics along with the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals, veterinary instruments, wound care and disinfectants.

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