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Randox Has Cooked Up a Full Plate of Protein Diagnostic Chips: Seeking FDA Approval

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Just about every chip company these days says it’s interested in “getting into diagnostics” somewhere along the line. In fact it’s almost a given that a biochip company’s PowerPoint presentation will end with the diagnostic angle.

But what about the converse trend, that of diagnostics companies “getting into” microarrays? These companies have considerable resources and know-how in the clinical diagnostics arena they can use to create parallel array-based assays. Despite these resources, few have ventured into the area far enough to get to the product stage. An exception, however, is Randox, a UK-based diagnostic company with nearly 500 employees and subsidiaries in 12 additional countries.

The company, which was founded in 1982 and is headquartered in Crumlin, Northern Ireland, is the largest manufacturer of clinical chemistry diagnostic reagents in the UK. Recently, Randox scientists have added to their product offering both antibody and antigen microarrays for diagnostics, according to a recent presentation by Randox scientist Mandy Wright. The biochips the company is developing include ones with sandwich immunoassays for thyroid hormones, fertility hormones, allergen-specific IgE’s, antibiotic drug residues, and drugs of abuse, cardiac markers, and tumor markers. The company has also made a cytokine and growth factors chip.

The company has also developed an analyzer that allows automated assays for these 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, wash station, signal station, and imaging station.

Randox has just finished evaluations of its drugs-of-abuse biochip at two test sites, and is currently marketing all of its chips except the IgE one, which is still under development, to a limited group of initial customers drawn from its pool of diagnostics customers, said John Lamont, the company’s manager of R&D.

The company plans to eventually produce these biochips in high-volume, at a manufacturing facility capable of churning out 20 million chips per year, Wright said.

This high-throughput facility is in fact ready to go, and Randox is gearing up for a full-on marketing effort, said Lamont. “We have a broad customer base and we have been telling them for the last two or three years this has been coming,” Lamont said. “We [also] have the key sites lined up.”

Does this mean that diagnostic protein chips have finally arrived? Randox hopes so, but there are still considerable obstacles having to do with cost and general resistance to new technologies in the already lucrative area of diagnostics.

“If you have an assay established in a scientific laboratory, it always takes years and years to take it to routine diagnostics,” said Thomas Joos, a biochemist at the NMI Natural and Medical Sciences Institute at the University of Tuebingen in Germany.

Randox, in fact, started to develop its diagnostic arrays 10 years ago, according to Lamont.

The main obstacle is approval of a test by the US Food and Drug Administration, (which can be initially circumvented by selling your test as a home-brew). This approval is the obvious benchmark of success, but requires millions of dollars in investment. Luminex of Austin, Texas, is the only company to have won this approval for its microarray-like bead assays — indirectly through its commercial collaborators. Nanogen is working in that direction, but the three-to-four-figure price tag of a single NanoChip for the system is prohibitive for high-throughput diagnostic labs, according to tech watchers.

Randox also aims to get FDA approval for its system by the end of the year, Lamont said.

Even with this passport to the diagnostic market in hand, the company is likely to face stiff competition from other non-array diagnostics producers, which it has to compete with on cost per assay. But Lamont sees the company’s throughput capabilities as a key advantage. “The other [advantage] is that we will be able to add on tests rapidly to each chip and improve the specificity for diagnosing particular diseases,” he said.

Could another big diagnostics player usurp Randox’s first-mover position by gobbling up a microarray producer or getting in quickly itself?

Not yet, it seems. Boeringher Mannheim, which was acquired by Hoffman-La Roche in 1989, had developed a fully automated microspotting system for multiplex immunoassays, said Joos, but the system never made it to market.

“I don’t think the diagnostic companies want to get into microarrays because as long as they earn money with a standard assay format, why should they invest in the development of other systems?” Joos said.

— MMJ

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