The Campylobacter bacteria affects 2.5 million people each year in the US.
Invisible Sentinel’s Veriflow test uses a molecular detection system designed to comply with stricter food testing standards. Its designed to speed up the time it takes to identify whether samples are contaminated. It is also intended to make it easier to use and more easily transported. The assay utilizes a PCR detection method coupled with a rapid, visual, flow-based assay that develops in 3 minutes post PCR amplification and requires only 24 hours of non-specialized incubation for maximum sensitivity. The Veriflow™ Campylobacter system eliminates the need for microaerobic chambers, gel electrophoresis or fluorophore based detection of target amplifications, and does not require complex data analysis.
Once the AOAC greenlights a performance tested method, it is recognized by the US Department of Agriculture, the Food and Drug Administration, certain European Union counterparts and other global regulatory agencies.
Ben Pascal, the CEO, said its manufacturing facilities in the University City Science Center is up and running and the company is talks with distribution partners in the US and Europe. The Campylobacter assay is the first in a suite of tests that are expected to be rolled out out next year for listeria, E. coli and Salmonella. The company expects to more than double its staff of 12 next year, to support sales and marketing.
Pascal told MedCity News earlier this year that its diagnostic platform could be used to detect hospital acquired infections. Such a move would require securing 510(k) approval from the U.S. Food and Drug Administration, but Pascal said the design of its diagnostic platform means that when the company is ready to shift its attention to HAI, it could make such a submission in a relatively short timeframe.