Vivione partners with FDA to expand pathogen detection tech

By Joseph James Whitworth contact

- Last updated on GMT

Vivione's RAPID-B system
Vivione's RAPID-B system

Related tags: Bacteria, Chief executive officer, Food

Vivione Biosciences has partnered with the Food and Drug Administration (FDA) to expand its diagnostic system for detecting bacterial pathogens.

The three-year Cooperative Research and Development Agreement (CRADA) is with the FDA’s National Center for Toxicological Research (NCTR).

The Vivione RAPID-B system looks at each bacterium's physical properties (including size, shape, and transparency) and analyzes responses to probes and DNA dyes.

RAPID-B allows testing of food products in seven hours or less, including sample preparation versus other commercial systems that take up to 48 hours to provide results.

Quick results

Kevin Kuykendall, chief executive officer at the firm, told that the system uses hardware, software and wetware.

“Food factories have two shifts on and one shift off to clean, if you get results of that cleaning two days later it is two days of inventory that you have produced. With RAPID-B you can shut the line down, reclean and not waste any inventory.

“You cannot diagnose quality on end products, it has to start on incoming products, it is too late with end products, you need to catch it further up.”

He said the firm, formed seven years ago, had E.coli and STEC going through AOAC validation at the moment with results expected in Q1 2014.

AOAC ruling on the Salmonella platform was targeted for Q3 and on Listeria in Q4 2014.

Upfront quality

Imports and exports represented a tremendous food safety opportunity, said Kuykendall.

“You can’t get quality at the end so it is important to work at prevention and give manufacturers the chance to monitor anti-microbial use, as they are treating every machine and every animal the same to knock down infections.

“You could use this system in a preventive measure, when you clean the line at the moment you clean all the lines because you have no data.

“Swabs are taken to test machines and then they strike the plate but with RAPID-B you know you have got to clean that one with that much anti-microbial and that it is not the same as the next one because you can see how the different machines are trending.”

He said it was the “perfect storm​” for the firm with manufacturers in the middle of a squeeze between the Food Safety Modernization Act emphasis on faster and more sensitive testing and customers, such as supermarkets, pushing back to reduce recalls and risk.

Kuykendall said the partnership with Kirkegaard and Perry Labs​ would take months out of the process towards commercialisation.

“[They] are antibody manufacturers so they develop and produce antibodies and the time and cost saving involving using their antibodies in our system is months and half a million dollars per assay.

“We are a small but nimble company and we have some good partners, such as the FDA but we know we will have to partner with someone to get the distribution done for our TB and prions products.”

Related topics: R&D, Lab instruments and equipment

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