With media reports highlighting the problem of foodborne pathogens like Salmonella in cantaloupe and e Coli in ground beef, a life science company is preparing to launch the first of a group of diagnostic platforms designed to simplify and improve detection of the four most common foodborne pathogens. Its applications go beyond the food industry and it could be used to improve detection of hospital acquired infections.
The outbreaks have been followed by an uptick in testing food in the U.S. for microbial contamination, according to a report published last year by Strategic Consulting.
Invisible Sentinel has set up pilot manufacturing facilities in the University City Science Center in Philadelphia as it awaits regulatory approval for its diagnostic system for a bacteria most commonly associated with chickens, Campylobacter jejuni, CEO Benjamin Pascal told MedCity News in a phone interview.
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The AOAC International, the Association of Agricultural Chemists, a nonprofit scientific association and regulation body, is expected to give its decision this fall. Invisible Sentinel will later seek approval for its Cartridge Sentinel as a diagnostic system for listeria monocytogenes and eventually E. coli O157:H7 and Salmonella enterica. The Science Center has been home to the company since it was launched.
Pascal said its diagnostic platform could be used to detect hospital acquired infections, a frequently cited problem by providers keen to improve readmission rates to avoid any Medicare reimbursement penalties. 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.
Pascal said current technology to test food frequently produces false positives and takes several hours and is unwieldy. Its own technology is compact, can be used by non-scientists is pocket-sized. “We are as fast as the most sophisticated technology on the market, we do it without the high learning curve, the data is extremely easy to interpret, and we’re lowering the hurdle to do complex molecular lab testing,” said Pascal. He described the food testing market as dominated by handful of major players.
“Food is a white hot industry right now,” said Pascal. He pointed to the groundbreaking Food Safety Modernization Act signed into law last year as the first significant change in food safety regulation in 70 years, which raised food safety standards for foods grown and processed domestically as well as for goods that are imported.
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Prior to working full-time for Invisible Sentinel in 2008 when the company secured its first offering, Pascal worked in research and development department of medical device manufacturer B Braun. To date, the company has raised $5 million from angel investors.
About 48 million people gets sick from foodborne diseases each year with 128,000 requiring hospitalization and 3,000 dying from the illnesses, according to the Centers for Disease Control’s website. It estimates the market opportunity for the food safety market in the U.S. to be more than $1bn and with more stringent regulations in Europe, the market opportunity there is even higher.
