Crystal Diagnostics inks agreement with Hardy Diagnostics

By Joseph James Whitworth

- Last updated on GMT

The CDx Xpress System
The CDx Xpress System

Related tags Escherichia coli

Crystal Diagnostics (CDx) has signed an agreement with Hardy Diagnostics to sell and distribute its pathogen detection platform in North America.

The CDx Xpress System combines proprietary liquid crystal technology with antibody-coated paramagnetic microspheres (read how it works here​) to selectively capture and detect an organism from food matrixes.

The agreement adds an equipment line to Hardy’s position in food safety testing reagents and proprietary enrichment media. 

Partnership benefits

Jim Bruce, CDx president and CEO, told FoodQualityNews that the firms met at IAFP last year and Hardy was intrigued by its unusual technology which he claimed was faster, more accurate and generally less expensive.

When asked about the benefits of the partnerships, Bruce said: “There are two things, this is a high tech field dominated by companies such as DuPont and 3M and there is massive competition.

“Credibility is very difficult to obtain so to go with Hardy who have a good reputation in the food testing arena with their proprietary media, it gives us instant credibility. It was important to them to come and see how we worked and speak to our people, as they didn’t want to align with something that wouldn’t work in the market.”

In the past twelve months Crystal Diagnostics has sold Xpress Systems to a number of processors, government and commercial test labs, as well as academic and research organizations.

This includes a sale to the US Food and Drug Administration (FDA) in College Park, Maryland and it has leased a system to the USDA in Nebraska where it does the majority of its beef research.

The system has AOAC accreditations, including E. coli O157 and the “Big 6” STECs (serogroups O26, O45, O1O3, O111, O121, and O145).

Bruce added it was clear it could not enter the market without AOAC accreditation.

For time to result, it takes 10 minutes after enrichment which is nine hours compared to PCR where it can take 12-16 hours.

The firm expects accreditations for Salmonella and Listeria by the end of Q1 2016 and Campylobacter in summer this year. 

Crystal Diagnostics is the exclusive licensee of liquid crystal technologies developed through a research partnership between Kent State University and Northeast Ohio Medical University.

Why Hardy and future plans

Christopher Catani, Hardy corporate vice president, said, “Distribution rights for the unique CDx detection system clearly demonstrate the Hardy commitment to bringing the most advanced, fastest, and most accurate diagnostic system to our customers."

Hardy Diagnostics manufactures over 2,700 products for the culture and identification of bacteria and fungi.

The firm employs more than 300 people and has nine distribution centers in the US.

Manufacturing takes place at its headquarters in Santa Maria, California and a facility in Springboro, Ohio. The company also exports products through over 65 foreign distributors.

Its portfolio includes products used to culture and detect pathogens, such as E. coli, Salmonella and Listeria. It claims more than 9,000 laboratories use Hardy Diagnostics for their supplies.

Bruce said Crystal Diagnostics is in the process of drafting contracts for distribution in Central America and Australia and also sees Europe as a market of interest. 

“FSMA regulations are starting to get implemented after industry was somewhat resistant. There will be a lot more testing as food safety is a major issue and from everything I’ve seen it is growing around 10% every year. 

“Foods are travelling further and further afield, it is not just local produce anymore. It is truly international and these longer distance times are an opportunity for spoilage organisms to grow."   

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