SQI Diagnostics said this week that it will design a food-testing panel for Silliker, a global network of laboratories that provides nutrition, food safety, and quality assurance.
Under the terms of the agreement, Toronto-based SQI will create an array-based assay to test for the presence of food-borne botulism, a harmful toxin produced by the bacteria Clostridium botulinum found in environments with little oxygen, such as in canned food.
SQI said it has already developed a prototype of the panel, called IgXplex BOTX, which will run on its SQiDman instrument. Silliker has agreed to purchase SQiDman systems and IgXplex consumables from SQI upon successful development and validation for the test panel and system.
SQI has granted exclusive global market and distribution rights to Silliker to resell the assay and SQiDman system to its customers, which include some of the world's largest food companies, the firm said. SQI will also be responsible for commercializing the IgXplex panel, and Silliker will validate the assay and complete and file all regulatory documents related to its clinical use in the different markets it serves.
Food testing is a new market for SQI. The firm in November 2009 received US Food and Drug Administration clearance to sell its array-based IgXplex rheumatoid arthritis assay in the US (BAN 11/3/2009). The RA assay is used to help physicians diagnose and monitor patients with rheumatoid arthritis. The company received Health Canada licenses to sell the test and system to Canadian labs in 2008 (BAN 12/2/2008). SQI has said it plans to file a Celiac Panel with US and Canadian regulatory agencies this summer, and to file a Vasculitis Panel with the same agencies by year end.
The Canadian firm's product portfolio consists of its internally developed, automated SQiDWorks system and QuantiSpot, a 96-well microarray consumable. SQiDman is a semi-automated version of SQiDWorks for lower-throughput users. The system can typically process multiplexed assays to quantify serum concentrations of up to 12 individual biomarkers, or qualitatively detect up to 24 biomarkers per patient, according to SQI.
CEO Claude Ricks said in a statement that SQI's "emerging customer relationship with Silliker is a continuation of our commercialization process overall as a company and in particular for the [food-testing] market." He said that SQI intends to work with Silliker in expanding its use of food-toxin and antigen-based multiplexed testing on the SQI platform, and will seek to "build out a pipeline of tests in this field."
"This is the first microarray-based food test we've done," Chief Financial Officer Andrew Morris told BioArray News this week. Other tests in development for Silliker are "mostly multiplexed panels directly assaying the presence of toxins or food-borne pathogens," he said. He did not elaborate.
Based in Chicago, Silliker is part of Institut Mérieux, the French holding company that also owns and operates Marcy l'Etoile, France-based in vitro diagnostics firm BioMérieux and Strasbourg, France-based Transgene, a biotech company. Silliker has 50 locations worldwide and employs around 3,000 people.
Morris said that Silliker will likely seek to regulate the introduction of IgXplex BOTX in the US market by making sure the assay meets AOAC International guidelines. AOAC is a non-profit scientific organization that sets standards for chemical and microbiologic analyses.
Russ Flowers, chairman and chief scientific officer of Silliker, said in a statement that the lab network believes there is a "great opportunity to be the world's first commercial user of the only microarray-based multiplexed test for food-borne botulism." Current methods of botulism testing include enzyme-linked immunosorbent assays, electrochemiluminescent tests, mouse inoculation or feeding trials, and culture.
While Silliker could be the first food safety provider to offer array-based botulism testing, other lab networks are adopting array technology for food testing. For instance, Indian testing giant Super Religare Laboratories last year began offering food intolerance testing on Omega Diagnostics' Genarrayt platform (BAN 6/23/2009).