Northern Ireland-based Randox Laboratories and economic development agency Invest Northern Ireland have announced plans to invest £123 million ($203 million) into commercializing Evidence, the company’s biochip protein array technology.
The “Evidence” system is an automated biochip-based protein analysis platform that the company says can be used to conduct as many as 25 or more single sample tests simultaneously from as many as 180 patients per hour on a 1 cm² chip. The company will start with 25 mainly cytokine-based tests on the platform, and add content as market demands require.
The system includes the Evidence analyzer, which automates assays for the biochips. The analyzer consists of a twin carousel, which is designed to enable continuous operation of the system, and a loading area, a reagent/sample addition station, an incubator, a wash station, signal station, and imaging station.
The technology has been in development for nine years and represents an investment of £55 million ($92 million) thus far, the County Crumlin, UK-based company said.
The company is not alone in its space, with a list of competitors stretching from the Roche Diagnostics/Affymetrix duo, to Affibody, Biacore, Ciphergen, Metrigenix, PerkinElmer, and Zyomyx. However, few have made such a lofty financial commitment to commercializing a very early-stage technology.
Invest Northern Ireland said in a statement that it is offering Randox £16.2 million ($26 million) in employment grants and financing repayable in preferential shares, and an additional £1.8 million ($3 million) toward the cost of establishing a center of excellence. The company will provide the remainder of the funds from its operations.
Some of the funding is part of a year-old effort by the agency to pursue venture capital investment, Jim O’Connor, the Boston-based vice president for business development for INI told BioArray News.
The funds derive from tax monies and are part of a strategic effort to boost the biotechnology sector in Northern Ireland, he said.
“We are trying to key off the expertise in the indigenous workforce and the educational system, which is strong in life sciences,” O’Connor said. The agency expects this funding to help Randox create as many as 800 new jobs over the next three to five years, ranging from professional positions to laboratory technologists.
Taking Care of Baby
The Evidence technology was launched in 1998 in Malaysia, at the Asian Pacific Congress, said Clement Fitzgerald, the firm’s marketing director. The family-owned diagnostics company, founded in 1982, has a team of 170 people working on the system developed in collaboration with Queens University of Belfast and Langford Lodge, a Crumlin, Northern Ireland-based engineering firm.
For Randox, Evidence is “our little baby,” said Fitzgerald. “We are not a research company who takes a technology to the point of development. We are a classical clinical chemistry company — that’s our bread and butter — producing diagnostic proteins and enzymes and increasing our business 40 percent each year for 21 years. We made a decision that we must have equipment and we took a look at a range of technologies that were being prophesized and microarrays was what we choose. Everything we have earned, we have put back into R&D.”
And protected it with patents, he said.
Randox has nearly 20 patents on its system, said Fitzgerald. The patents that are applicable this device, according to the United States Patent database are US Patent Nos. 6,498,010; 6,341,182; and 6,308,751.
No. 010 is “Method for making a device for the simultaneous detection of multiple analytes.” The patent, granted on Dec. 24, 2002, describes a multianalyte system comprising a solid state device of 1 cm² and a process for covalently binding ligands to a hydrophilic substrate surface that is non-uniform and may contain features such as channels, pits, wells, or pillars and is constructed of ceramic (aluminum oxide), quartz, glass, or silicon. The probes can be attached over constructs of latex, dendrimers, or polyethylene glycol. Also included in the invention is an integrated analysis system, including sampling and liquid handling units, a temperature-controlled dark box, a CCD camera, and image processing software.
The company also has US Patent No. 6,341,182, “Method and apparatus for analyzing an image,” and No. 6,308,751, “ Liquid dispensing apparatus.”
Location, Location, Location
The company, Fitzgerald said, has so far delivered 18 of the systems, which are about 5 feet high and 7 feet long and can operate self-contained, or attached to plumbing, as well as to a mainframe computer.
According to a news report in the Financial Express, an Indian publication, Apollo Hospitals, a Hyderabad, India-based healthcare services provider, has installed the Evidence protein biochip analyzer and is seeking to create a genetic research and diagnostic center in Hyderabad to provide services to other hospital groups and to expand on an already-established molecular diagnostics center.
“The only thing that holds us back is choosing where to put it in,” Fitzgerald said. The company has placed the systems throughout the world in the six months that it has been offering it commercially.
Evidence has earned its CE mark, a European regulatory standard, and the US Food and Drug Administration is reviewing the system, Fitzgerald said.
The company has the capacity to produce 20 million of the biochips a year, and has tested the system with a pilot run of 3 million. It also has a separate system for producing the instrumentation.
“We are not standing out drinking tea and waiting for a bit a half a centimeter smaller: We mill our own [drill] bits,” he said. “We are a solution driven company.”
Randox, a UK-based diagnostic firm with nearly 500 employees and subsidiaries in 12 additional countries, is counted as the largest manufacturer of clinical chemistry diagnostic reagents in the UK.