Randox, a Crumlin, UK-based medical diagnostic company, will launch a microarray for colorectal cancer in the first quarter of 2006 and is preparing a chip for breast cancer later that year, BioArray News has learned.
Clem FitzGerald, the firm's marketing director, told BioArray News that the chips will be sold for research use only until Randox completes clinical trials for the early-stage cancer diagnostic chips. Both arrays are used with Randox's Evidence Investigator system, a newer, more compact version of the larger Evidence Analyzer system the company launched in 2003 for biochip assays (see BAN 7/2/2003).
"[These] DNA biochips are for use with Evidence Investigator. The Evidence Analyzer has been designed for high-throughput protein analysis and is targeted towards arrays of cytokines, drugs of abuse, cell adhesion molecules, et cetera," FitzGerald said.
According to FitzGerald, the Ranplex colorectal cancer arrays are focused assays that test for 28 mutations. The Ranplex breast cancer biochip, which is still in development, has not been finalized, but FitzGerald anticipated that more than 20 SNPs will be selected.
Randox has invested £65 million ($115 million) into its biochip portfolio since it was founded in 1982 and is focusing more on content, rather than instrumentation, FitzGerald said.
"We've been running your typical cardiac profiles and liver profiles for many, many years, but they haven't changed an awful lot. And it became a number-crunching game, rather than a real information game. So the whole industry has to rethink what it is doing and show and prove the value of the result."
"[We are] working on more content and different disease areas," he said, including tests for cancer, heart disease, and arthritis. "All of us in what I call the in vitro industry are trying to show value for the test results that come out of the systems. We've been running your typical cardiac profiles and liver profiles for many, many years, but they haven't changed an awful lot. And it became a number-crunching game, rather than a real information game. So the whole industry has to rethink what it is doing and show and prove the value of the result," FitzGerald said.
To be sure, Randox isn't the only company that has expressed an interest in colorectal cancer and breast cancer diagnostics. Roche, the world's largest diagnostic company by market share, has signaled publicly that it is interested in introducing an AmpliChip test on the Affymetrix platform for colorectal cancer in the future (see BAN 9/8/2004).
And other in vitro diagnostics players such as BioMérieux, DiaGenic, and Agendia, have all expressed interest in breast cancer, most notably Agendia, which last year launched its MammaPrint test that assesses breast-cancer recurrence risk (see BAN 5/19/2004).
Part of how Randox has decided to "show value" for its tests has been to make its array technology more accessible by, among other things, making it smaller. Until a year and a half ago, assays using the company's chips were run on the company's fully automated Evidence Analyzer, which is 5 feet tall and 7 feet long.
With the new Evidence Investigator, the company "took the large automated [Evidence Analyzer] system, [took] the camera out of that, connected it up with software, and added a manual application whereby you do the prepping and incubation stages manually [to create a benchtop sized system]" FitzGerald said. "This means you've got a lower-cost access to the biochip technology."
He said that the system was initially called Investigator because it was designed for research purposes, "but some lower-throughput clinical labs are thinking of using it for routine testing as well, because we do have routine clinical chips."
FitzGerald added that the new chips will "initially … be launched for research investigating the true benefit and relevance of detecting gene mutations in colorectal cancer. Only then will we understand their suitability for diagnosis, prognosis, and predicting recurrence."
He said that Randox is seeking partners for early-stage clinical trials for the colorectal cancer chip. "We are at a stage at the moment where we are really looking for good centers to check out these chips and use them as a tool."
"We are actually seeking suitable partners to do the first-level clinical trials at the moment," he said.
As the company rolls forward with the content arrays for its Evidence Investigator it has also been racking up array-related IP in the US. Last Spring Randox received a trio of patents related to its array technology.
According to the United States Patent and Trademark Office database, the company received US Patent No. 6,881,572, "Assay device incubator," in April, followed by US Patent No. 6,897,026, "Array imaging method," in May, and US Patent No. 6,902,897, "Biochip deposition system and method," in June.
Specifically, the '026 patent describes a "method used to locate the reaction sites accurately on [an] array, and to correct for any misalignments." The '897 patent claims a system that deposits spots on array.
FitzGerald told BioArray News in 2003 that Randox also has around 20 patents related to the Evidence Analyzer system.
Justin Petrone ([email protected])