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Febit Glimpses Future in Diagnostics Market Through University of Leicester Installation

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Last week, Febit Biotech announced that the University of Leicester in the UK had purchased two of its Geniom microarray systems for research purposes.

Specifically, the German array company said that the first Geniom system was set up in Leicester in June, and that the second system will be installed in late summer. The university will use the system for DNA analysis, Febit said.

Febit's client in the Leicester deal is Anthony Brookes, a professor in Leicester's Department of Genetics, as well as an adjunct professor at the Karolinska Institute. Although Brookes has worked with partners in the past that have used array technology, it is actually Brookes' first microarray system.

Brookes said this week that he plans to translate a new DNA analysis technique he has developed called dynamic allele-specific hybridization, or DASH, to the Geniom platform, and added that DASH may be suitable for diagnostic applications down the road.

While Brookes stressed that the path to commercialization is "up in the air," he maintained that "the main application for DASH on this platform is DNA diagnostics."

The fact that Febit's clients are preparing diagnostic assays on the Geniom system offers a glimpse into Febit's possible future, according to a company official.


"Febit's long-term vision is to use the underlying technology, [which will be] proven and applied in the research area, to build a next-generation molecular diagnostic platform."

Peer Stähler, Febit's chief scientific officer, told BioArray News this week that while Febit is currently focused on the research tools market, it does have long-term plans to enter the diagnostics space as an array-based diagnostic platform provider, similar to Affymetrix or Osmetech.

"Febit positions itself as a provider of tools — instruments, reagents, system business — for the research market," Stähler said. "The target customers are biomedical, biology and biotechnology professionals in academia, pharma, and diagnostics companies," he explained.

"Febit does not push towards diagnostics too much; instead, we feel quite comfortable with using our platform for research," he said.

Febit's "long-term vision," however, "is to use the underlying technology, [which will be] proven and applied in the research area, to build a next generation molecular diagnostic platform," Stähler said.

"We anticipate this to happen several years from now. In the meantime, the content — which is, what targets to look at and why — will improve, and the molecular diagnostics market will be prepared for the next level of product," he said.

Once that happens, it is likely that Brookes' DASH application could be one of the initial assays to run on the platform. "The combination of DASH with our fully flexible custom microarray platform is very likely to then form part of the diagnostics platform we will develop," Stähler said.

DASH

Brookes said that DASH addresses what he feels has been a systemic problem with microarray applications — the expectation that all DNA molecules are optimally hybridized under the same conditions.

"For array experiments based on hybridization, the field for a decade now has been running their experiments with single-temperature hybridization and a single-temperature stringent wash," Brookes said.

"What we've been doing is looking at how the DNA melting process happens on these arrays as you increase the stringency or steadily heat the temperature," he added.

Brookes' solution is DASH, where the oligonucleotide is hybridized at a low temperature and then heated under controlled conditions. "Then we just watch the point at which it denatures and that causes the fluorescence to go away. It's not just a case that the hybridization signal is on and then it just goes away. It melts with a certain sigmoid curve. And you track that curve," Brookes said.

According to Brookes, "all different sequences in different sequence contexts will hybridize at the start of the experiment, be denatured at the end, and there will be a melt curve in between that is specific to the individual sequence."

"Whatever the genes, they will all give an accurate indication of their sequence content relative to the probe that was hybridized to them," he said. Such capabilities could provide clinicians with a "way to resequence any gene or sequence of genes with very high precision and with nothing to optimize in the assay."

The DASH technology can then be used to produce SNP genotyping assays that do not require optimization, but provide the user with reliable results. That capability could be useful in the diagnostic arena, Brookes said.

"Obviously there are certain genes out there that would be of interest in that respect — certainly cystic fibrosis and breast cancer," he said.

While Brookes stressed that his diagnostic plans for DASH are long-term, he said that he has considered its path to commercialization.

"Ultimately, if there are these high-use applications, the idea with a company is that we will design a system where people won't have to buy the system that makes the arrays, they'll just have to buy the reader. And we'll [make] the arrays for their genes or genes of interest," he said.

Still, he added that it's "all up in the air how we actually bring this through to market."

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