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FDA Clears Hologic's In Vitro Diagnostic Test for the Qualitative Detection and Differentiation of Five Common Bacterial Pathogens Associated with Gastrointestinal Illness

Unlike tests involving culture-based methods, the new Prodesse ProGastro SSCS Assay allows labs to test the common bacterial pathogens associated with in hours instead of days

Hologic's Prodesse ProGastro SSCS Assay, a real-time multiplex polymerase chain reaction (PCR) in vitro diagnostic test for the qualitative detection of the most common bacterial pathogens associated with gastroenteritis, has been cleared for marketing by the U.S. Food and Drug Administration (FDA). 

This Assay is intended for the detection and differentiation of Salmonella, Shigella, and Campylobacter (C. jejuni and C. coli only, undifferentiated) nucleic acids and Shiga Toxin 1 (stx1) and Shiga Toxin 2 (stx2) genes. With Hologic's new Assay, diagnostic laboratories will no longer need to wait 48 hours or more for culture results, which may be ambiguous. Not only does this cost-effective solution help streamline lab workflow, but it is easily scalable and fits the mid- to high-throughput setting. 

The Prodesse ProGastro SSCS Assay runs on a common bench-top platform that exists in many laboratories. The ProGastro SSCS Assay has been optimized to use the same samples that physicians are collecting and labs are already accustomed to processing for stool culture, streamlining the transition to a molecular detection method. 

About Prodesse 
Hologic's Prodesse business is a leader in respiratory infectious disease diagnostics, and the ProGastro SSCS Assay expands the infectious disease portfolio of the Prodesse product line. All Prodesse assays are simple to use and easily integrate into a lab's existing workflow. They have been optimized for use with automated extraction technology to minimize technician hands-on time. Test results can be obtained in as little as four hours, a significant improvement over culture-based methods that can take many days to provide a result. 

About Gastroenteritis 
According to the US Centers for Disease Control and Prevention, gastroenteritis is the inflammation of the stomach and small and large intestines. The main symptoms include vomiting and watery diarrhea; other symptoms include fever, abdominal cramps, nausea and headache. Infections causing gastroenteritis can be viral, bacterial or parasitic in origin. Infections causing gastroenteritis can be spread by contaminated food or water or through an infected food handler. CDC estimates that each year roughly 1 in 6 Americans (or 48 million people) suffer from gastroenteritis, 128,000 are hospitalized, and 3,000 die of foodborne diseases. 

Hologic, Prodesse, ProGastro and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.