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German Startup Clondiag Prepares Arrays And Sets Its Sights on Diagnostics Marketplace

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Clondiag Chip Technologies is one among a growing number of companies to place its chips onto the diagnostics end of the board. Based in Jena, Germany, the company has been developing easy, reliable, and inexpensive platforms for diagnostic laboratories or point-of-care diagnostics.

“What we are aiming to create is a cartridge similar to a pregnancy test,” said Eugen Ermantraut, Clondiag’s managing director for science and technology. “You just supply your sample, for example a drop of blood, and everything — like target amplification, hybridization, and detection — happens within the cartridge.”

This product, Ermantraut said, will be ready next year. Meanwhile, the company launched its initial platform-- arrays in a microtube — earlier this year, and last week announced it had co-developed a fluorecence reader for the system with Canadian company Biomedical Photometrics, and that both companies will now be selling the tube arrays.

Fueled by State VC

Clondiag‘s technology, and its five founders, come out of Jena’s Institute for Physical High Technology (IPHT) and the Hans-Knöll-Institute for Natural Product Research. Initially funded by private capital from the founders in 1998, the company attracted € 4 million from Venture Capital Th ringen, a regional venture fund run by the state of Thuringia, and TBG, a venture fund of the federal state of Germany, in December 1999. Undisclosed revenues from products and partnerships with other companies have further fueled the company’s research and development, which has so far consumed € 11 million. Soon after its founding, Clondiag outgrew its first home at the IPHT and moved into its own space, now occupying 9,000 square feet and employing 35 people.

Stealth Launch in 2002

The first year, Ermantraut remembered, was spent “playing around with different methods and models, and carrying out some feasibility studies to determine where we would go.”

After figuring out what technologies it needed to develop in-house, the company decided to forge ahead quietly “because we were convinced it would be a good idea to start with the launch of a product into the market, without a big fuss about the technology,” said Ermantraut.

That happened in April 2002, when Clondiag introduced its ArrayTube platform, microarrays in the bottom of a microtube, which it aims at diagnostic researchers for genotyping and SNP analyses, although they are also available as antibody arrays The 3.4 mm by 3.4 mm glass-based arrays are custom-made and can be either spotted — with up to 144 features — or carry up to about 4,000 features of in situ synthesized 24 mer oligos.

Clondiag uses its own patented in situ synthesis technique, called micro wet printing, which utilizes conventional DNA synthesis chemistry, as well as fluidic masks and microchannels to direct acid to certain areas on the array.

Keeping Reader Costs Low

The cost for each tube array is “far below €100,” said Ermantraut. Unlike most other microarray platforms, the system uses detection based on simple light transmission rather than fluorescence. Colloidal gold particles are attached to the target and, after hybridization, the signal is enhanced by allowing silver to precipitate on the gold particles. A special reader measures the light passing through the array.

Though the company stresses the low cost of its reader — it sells for less than €20,000 — the unconventional and non-linear detection method might have put off some potential customers, possibly explaining Clondiag’s partnership with Biomedical Photometrics to develop an alternative fluorescence reader. “It is expected that the addition of this new fluorescence reader will accelerate customer acceptance and implementation of the ArrayTube platform,” Clondiag said last week in a statement announcing the new reader.

But Clondiag does not only rely on manufacturing and selling custom arrays to end users. At the moment, it is partnering with several companies to develop biological content for off-the-shelf tube arrays. A thrombosis chip, developed in collaboration with Ogham Diagnostics in M nster, Germany, will soon be marketed by Ogham, said Ermantraut.

Several other catalogue arrays will be available in 2003, he added. These will be marketed and sold by other companies as well: “Clondiag is still lacking efficient marketing and sales channels, which we definitely need in order to be successful,” Ermantraut said.

Meanwhile the company’s point-of-care genotyping platform, called Assay Processor, is nearing completion, with a prototype already finished. Each AP cartridge contains a 3.4 mm by 3.4 mm microarray with up to 4,000 features, its probes synthesized by micro wet printing. Integrating a heater, the cartridge combines target amplification, labeling, and hybridization. Detection occurs via fluorescence.

Ermantraut said the system will be first commercialized next year by a company that has been developing a pathogen detection assay for it. However, Clondiag is eager to find more partners to develop further applications.

Patent, Then Publish

In order to increase the visibility of its technology, Ermantraut said, the company is currently preparing several articles, to be published in scientific journals. A number of the 20-plus patents the company has filed have been granted, he said, so “now we feel confident enough to publish scientific and technological details on the performance of the platforms and the technology behind it.”

Apart from its two main platforms, Clondiag has also developed a fluorescent polymer array that can serve as a standard for data normalization and a microarray LIMS system.

— JK

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