Food safety testing company Hygiena has launched the BAX System Real-Time PCR Assay for Highly Pathogenic Salmonella, a test that goes beyond detecting Salmonella and looks for genetic markers linked to the strains that most often make people sick. The assay was developed with the U.S. Meat Animal Research Center (USMARC) of the U.S. Department of Agriculture’s Agricultural Research Service (USDA-ARS), and was announced at the end of September 2026.
From presence to virulence potential
“For decades, pathogen testing has largely answered a binary question: Is salmonella present, or not?” said Steve Nason, Chief Executive Officer of Hygiena. The new assay is meant to add a second layer of information about the Salmonella that has been found.
Not all Salmonella strains carry the same risk. Of the more than 2,500 known serotypes, a relatively small number cause most human illness. A test that only reports presence or absence cannot distinguish between them.
How the assay works
The assay detects Salmonella spp. and up to three proprietary virulence-associated genetic markers. According to Hygiena, these markers are linked to the serotypes most frequently associated with human illness.
It is designed as a reflex test. Laboratories run it only after a sample has tested positive with the BAX System Real-Time Salmonella assay, using the same lysate from the original enrichment culture, so no new sample preparation is needed. Results are available in under 90 minutes. The kit contains 96 reactions in a lyophilized format with an internal positive control, and covers enrichment cultures from poultry, beef, and pork.
Research use only
Hygiena states that the assay is intended for research and ecological surveillance. Its results are not to be used for food safety, regulatory, or product release decisions. The company describes it as a tool for researchers to study differences among Salmonella populations and their potential significance for human health.
The science behind it
The assay is based on the Highly Pathogenic Salmonella (HPS) concept developed by USDA-ARS scientists at USMARC in Clay Center, Nebraska. In a study published in Frontiers in Microbiology in 2025, the USMARC team compared complete Salmonella genomes and identified virulence genes found mainly in serotypes associated with human illness. They combined these into a multiplex PCR and tested it on 1,303 Salmonella isolates from 69 serotypes collected by the USDA Food Safety and Inspection Service.
That research assay reached a specificity of 96.3% and a sensitivity of 73.5% for identifying serotypes linked to human illness. The authors proposed it as a way to support risk-based approaches that focus on the Salmonella strains of greatest public health concern, rather than on all Salmonella equally.
Why it matters for testing laboratories
Regulators and the meat and poultry industry have been discussing for several years how to move from a presence-or-absence standard toward one that considers which Salmonella strains are present. Tools that add virulence information to routine PCR screening could help generate the data needed for that discussion, starting in research and surveillance settings.