Serosep’s EntericBio Dx Molecular GI Panel Cleared by FDA

Serosep Ltd. have been cleared by the US Food and Drug Administration (FDA) for the company’s in-vitro multiplexed nucleic acid based test for direct, qualitative detection and identification of common enteric pathogens from symptomatic individuals with suspected gastroenteritis.

The EntericBio® system detects target DNA directly from Cary-Blair stool specimens, circumventing the requirement for commercial nucleic acid extraction/purification. The EntericBio® Dx assay is provided in a lyophilised and ready to use format with automated reaction set up performed on the EntericBio® Workstation liquid handling robot. Amplification & detection is performed on the ABI 7500 Fast Dx real-time PCR instrument with fully automated results analysis using Ugentec Fastfinder EntericBio®Dx software. The system can process 1-30 patient specimens per run with consecutive runs every hour and first results available in <3 hours. The EntericBio system is the market leader in its segment in the UK/Ireland and provides the medium/high throughput lab with a rapid, reliable and easy to use solution for their enteric pathogen testing needs.

Serosep has announced the exclusive distribution of the EntericBio® Dx assay to the US market through Quidel Corporation. Quidel Corporation (Nasdaq: QDEL) is a California-based leading manufacturer of diagnostic healthcare solutions serving to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system.

“Quidel is pleased to be able to offer EntericBio® Dx system, a rapid, high throughput, molecular system with a multiplex gastrointestinal panel, providing results within 3 hours direct from sample.” Quidel CEO Douglas C. Bryant said in a statement.

CEO of Serosep Dermot Scanlon announced “Serosep is very pleased to partner with Quidel, a company that shares the same values of commitment to customer service and support. These values have set Serosep apart from its competitors ensuring EntericBio is now the most widely used Gastrointestinal Molecular Diagnostic test both in Ireland and the UK. Serosep is hoping to replicate this success in the USA through its co-operation with Quidel.”