Boston — Fleshing out the menu for its Evidence biochip systems, Randox plans to launch eight new panels this month for applications such as drugs of abuse, cerebral disorders, colorectal cancer, and cardiovascular disease.
The availability of the new content-specific chips will greatly expand the Crumlin, UK-based company's current offering for its Evidence systems, and makes good on earlier promises by management to grow its biochip portfolio by this spring, (see BAN 12/14/2005).
Angela Wilson, a product specialist in biochip array technology at the company, told BioArray News here last week during Cambridge Healthtech Institute's GOT Summit that the company plans to launch the chips in coming months.
Victoria Gault, a product specialist for the company, confirmed the product launch this week and said the assays are designed to work on Randox's 3-year-old automated Evidence Analyzer system, as well as its more recently released semi-automated benchtop Evidence Investigator system, Gault said.
According to Gault, the first two of the eight chips to hit the market are its antimicrobial panel, "designed to test for those drugs used in therapeutic and prophylactic treatment of animal disease," and a growth promoters panel, which "offers a simultaneous screen for a number of prohibited substances [that] increase the efficiency of animal weight gain, can stimulate the appetite and can increase aggression," Gault said.
"We should have a panel that will be appropriate to most settings; we have a very wide target market."
"These substances can prove detrimental to human health and thus it is important to have an effective screen for them," she explained. It will likely be marketed to government laboratories, dairy farms, veterinary labs, racing industries, slaughterhouses, and import-export houses, she added.
Over the next "couple of months," Gault said that Randox will release its Ranplex CRC array, for the detection of point mutations associated with colorectal cancer, and the Ranplex CVD array, which the company claims can detect 27 SNPs from across 22 genes to indicate predisposition to cardiovascular disease.
The CVD assay uses whole blood while the CRC assay uses stool. Both are based on an addressable tag array, Gault said.
According to Gault, the CRC assay "allows the amplification of low-abundance genes from a background of wild type DNA from stool." The company has timed its release with the Colon Cancer Screening Program in the UK, she added. Both of these DNA panels will be marketed to hospital labs, private clinics involved in screening, and CROs, Gault added.
She also said that the CRC and CVD assays will be released for research use only. "Especially the DNA chips will be used for the research market," Gault added.
Drugs of Abuse II
Randox does have plans to bring one of the new arrays through regulatory approval processes in the US and in Europe.
Gault said that Randox's Drugs of Abuse Array II, which extends the company's existing array "to accommodate trends in drugs currently being abused by humans," will "probably go forward" for regulatory approval. Randox already sells an older Drugs of Abuse panel, which was cleared by the US Food and Drug Administration for clinical use, along with the Evidence Analyzer system, in 2003. Both arrays screen for antibodies produced by the use of selected drugs.
According to Gault, Randox's new Drugs of Abuse panel "will be available for semi-quantitative analysis of urine, blood, and oral fluid [and] will be of interest to those working in any form of drug screening laboratory, medical examiners and toxicology departments, and police laboratories."
Randox's interest in providing multiplexing capabilities for drug screening could exploit an overlooked area in the microarray market. One company that has developed a similar screening tool is China's CapitalBio, which will be screening athletes at the Olympic Games in Beijing in 2008 (see BAN 2/14/2006).
Other companies, such as Fluidigm, sell customizable antibody array technology that could lend itself to such screening, but do not sell actual assays for drug screening (see BAN 4/4/2006).
Cytokine and Cerebral Arrays
To broaden its presence in both academic and pharmaceutical R&D operations, Gault said that Randox will soon release two cerebral arrays and the fourth installation of its cytokine array offering.
Gault said that Cerebral Arrays I and II have been "designed for research and clinical studies involving cerebral and cardiovascular disorders" and the "panels will be of use to those currently working within this field in hospitals and university research departments."
Randox's Cytokine Array IV will "extend [its] cytokine menu for research and clinical studies [and] will be applicable to a wide range of research projects, and will be of use to those working in research departments in hospitals and universities as well as [general clinical research centers] and pharmaceutical companies," Gault said. She did not indicate for which research projects the cytokine arrays could be used.
While the cerebral arrays appear to be a unique offering, Randox's cytokine arrays will compete directly with cytokine array products from rivals like EMD Biosciences as well as Takara Bio's Clontech subsidiary, which in January said it has plans to launch cytokine arrays in the future (see BAN 1/17/2006).
More on the way
According to Gault, the variety of the new products fits in with Randox's strategy of having a broad portfolio. "We should have a panel that will be appropriate to most settings; we have a very wide target market," she said.
It is also the result of increasing investments from the firm in R&D. Clem FitzGerald, the firm's marketing director, told BioArray News in December that the company has invested £65 million ($115 million) into its biochip portfolio since it was founded in 1982 and has been focusing more on content, rather than instrumentation (see BAN 12/14/2005).
At the time, FitzGerald said that the company was also working on a chip for early-stage breast cancer detection. He added that all of its arrays would be sold for research use only until they could be cleared by US and European regulatory agencies.
Gault did not comment on the breast cancer array last week, but indicated that Randox has plans to sell a biochip for brain disorders and disease in the future.
— Justin Petrone ([email protected])