The Veterinary Laboratories Agency, a UK government-funded network of 16 labs that surveil new and emerging diseases for the government and the animal-health industry, has won a £450,000 ($890,000) award from the Public Sector Research Exploitation to commercialize a line of array-based pathogen tests.
According to Andrew Soldan, commercial program manager for VLA, the capital, which it received last month, will enable the agency to sell its menu of Identibac tests to European customers for indications such as detecting antimicrobial resistance and virulence factors for bacterial strains such as Staphylococcus aureus, and Escherichia coli pathotyping.
“One of the things we have put a lot of time into in the last couple of years is the development of arrays in various guises,” Soldan told BioArray News last week. “Last year the only selling we did was to research collaborators, but from the beginning of this calendar year we have begun to sell to people who just wanted to buy the arrays. The money from PSRE will help support that work.”
VLA is responsible for diagnosis and surveillance of animal diseases in England, Wales, and Scotland. The agency has an annual budget of £100 million, with the majority of its funding coming from the government. However, VLA also has a commercial program that is responsible for exploiting internally developed intellectual property, and the agency sells services and tests to researchers both internal and external to VLA, Soldan said. He estimated that the commercial side of VLA has annual revenues of around £7 million.
Identibac is a more recent commercial project supported by VLA. Historically, VLA sold PCR assays for use in a network of labs. More recently, the agency partnered with Clondiag Chip Technologies, a Jena, Germany-based array firm, to develop array-based assays for several indications, all of which are sold through the Identibac business, which is wholly owned by VLA. Clondiag did not return an e-mail seeking comment by press time.
Specifically, the project with Clondiag offers Identibac antimicrobial-resistance detection and typing in gram-negative bacteria; Identibac EC for pathotyping E. coli; Identibac SA for identifying antimicrobial resistance and virulence factors in S. aureus strains; Identibac PA for identifying P. aeruginosa strains and for identifying virulence factors; and Identibac CH for identifying Chlamydiaceae species.
All five assays are based on Clondiag’s ArrayTube platform, which has been specifically tailored for use in serological and nucleic acid-based diagnostics. Soldan said that VLA decided to work with Clondiag because it found the ArrayTube to be the “most usable and near-market application for [the] type of arrays that we wanted to produce.”
“If it successful it will need to be spun out and stand on its own.”
The Identibac group, which includes around half a dozen employees, sells and supports the tests; VLA packages and ships the arrays, and invoices and bills customers.
Soldan said that while Identibac remains part of VLA, the agency definitely plans to spin the group out as an independent company, hopefully within the next few years.
“If it’s successful it will need to be spun out and stand on its own,” he said. “I expect that [to happen] in two to three years time, but we will just have to see how it goes.”
Part of the reason for VLA’s adoption of Clondiag’s platform is its price. A typical Identibac array costs £35 per tube. Soldan said that ArrayTube readers generally cost £5,000, and the remaining hardware — such as a PCR cycling machine and pipettes — usually cost about £2,000.
“It is very low capital to get into compared to many array systems,” he said.
According to Soldan, the main aim of Identibac is to replace current PCR tests in the field with the array-based assays. “When you only want to know about one virulence gene in an E. coli, then you can do it by PCR, but when you look for multiple ones, the time and cost become prohibitive, that is the gap in the market that [this technology] fits,” he said. “It allows you to look at a large number of genes, compared to PCR, but not compared to the larger arrays that are around. It is the right number for looking at these genes.” Soldan said that Identibac’s arrays usually include between 60 and 90 genes.
Soldan said that Identibac’s current customers include researchers investigating antimicrobial resistance or virulence. The firm is also developing a Salmonella chip that will become available sometime before the end of September.
“There are a lot of people doing PhDs, there is lot of national surveillance for [antimicrobial resistance] and changes in virulence genes. It is certainly a European thing now,” said Soldan, referring to an increasing incidence of MRSA. According to the European Antimicrobial Resistance Surveillance System, nearly half of staph infections in the UK and Greece, and up to a quarter in Germany and Spain, are methicillin-resistant.
He said that VLA already has the infrastructure in place to deliver the array-based tests to its customers, and that the relative novelty of the technology should not be a disadvantage in pushing the arrays out into the market.
“We sell a large number of diagnostic tests to UK and international customers already, so these would just be effectively other diagnostic tests we will sell,” he said. He added that Identibac will begin offering its antimicrobial-resistance assay as a service in the next month to six weeks.
Soldan said that VLA has not patented its Identibac assays, but noted that its probe design remains a trade secret, and the real value the tests bring to market is that they have been validated by VLA for use in diagnostic labs.
“It is difficult and expensive to validate these tests, and VLA has very rigorous validation system,” he said. “With the move to higher quality standards in most labs these days, the requirements for properly validated tests have grown a lot. That is one of the added value things that we have given it and it helps promote it and protect it from competition.”