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ExonHit Develops Array-Based BSE Test With Roche, Seeks Licensing Opportunities


ExonHit Therapeutics has validated biomarkers for blood-based detection of bovine spongiform encephalopathy in living animals through a partnership with Roche Applied Science, the company said last week.

Officials from the Parisian company said this week that ExonHit will exclusively retain all IP related to the discovery and that they are looking to license it to a partner that can finish developing a BSE Test.

"We are looking to license the IP," Laurent Bracco, ExonHit's vice president of research and technology development, told BioArray News this week.

Bracco said that ExonHit does not intend to become a diagnostics company, and instead would rather partner with larger companies in drug discovery, diagnostics, and biochips that can bring the technology to market. He mentioned that companies specializing in veterinary diagnostics could be an ideal vehicle for the new BSE test.

"You just take some blood and extract the RNA from the whole blood. So that's the difference; it is from the live animal. You don't need to take brain RNA and kill the cow."

"We are good at finding biomarkers and developing splice variant arrays, but we don't want to become a diagnostic company," Bracco explained. "We are looking [to partner with] a diagnostic company that has activities in the diagnostic market and further develop these assays. Roche is obviously one candidate, but we are looking for additional partners as well." The veterinary diagnostic partner will decide a commercialization route, Bracco said.

Bruno Tocque, ExonHit's CEO, told BioArray News this week that he believes there could be interest in countries with large beef industries, such as the US and Brazil for this kind of screening test. "There are companies in the US that are definitely involved in that kind of screening and that are moving away from the trend in diagnostics of post-mortem screening," he said.

Bracco provided statistics from the US Department of Agriculture's Foreign Agriculture Service that showed that Brazil slaughtered 36 million cattle for human consumption in 2004 compared to 34 million in the US and 26 million in the European Union.

Tocque said that the interest in developing such a test may be closer to home in the European Union, and Roche could explore that possibility.

Bracco said that the BSE collaboration grew out of Roche's interest in ExonHit's "expertise and IP in the field of alternative splicing and blood diagnostics." ExonHit saw the gesture as an opportunity because, as Bracco said, expensive BSE blood samples are easier for larger companies like Roche to obtain than for ExonHit.

"They proposed [that we] work on BSE since BSE was a hot topic in Europe [in 2003]," Bracco said. "They had the resources to get the blood samples that are required for making any progress in the field [and] we worked for two years on this project."

However, if Roche decides to develop a BSE test based on the collaboration it will most likely use quantitative RT-PCR instead of ExonHit's microarray technology. Roche Applied Science used RT-PCR to validate the biomarkers in the study, according to a statement last week. Bracco said that whoever develops the test further could use either arrays or RT-PCR.

"It has been validated through two different technologies — array-based detection and validated through quantitative PCR. You can use either one, depending on what type of technology you want to [use]," he said.

Bracco said "either technology would be appropriate as the number of markers is limited and the quantity of RNA derived from cattle blood would not be an issue either. The appropriate platform would be selected by the diagnostic company."

BSE Methodology

According to Bracco, the strength of the ExonHit-Roche BSE Test is that it relies on simple blood samples taken from a suspected animal, as opposed to brain RNA taken after the animal has died.

"You just take some blood and extract the RNA from the whole blood," he explained. "So that's the difference; it is from the live animal. You don't need to take brain RNA and kill the cow."

Bracco said that ExonHit used its qualitative gene-profiling technology, called differential analysis of transcripts with alternative splicing, or DATAS, in the experiments that yielded the biomarkers that could differentiate between pre-symptomatic BSE carriers and healthy individuals. The DATAS technology characterizes all the functionally distinct mRNA variants that differ between any two conditions, according to the company's website.

"We applied our proprietary DATAS technology to identify splicing alterations between the blood of infected versus normal cattle," Bracco explained. "A custom array was then built to be challenged with individual blood samples."

ExonHit did not use any of its different splice variant arrays in the BSE work. The company launched the SpliceArray service last February and signed distribution agreements with Agilent and Affymetrix this autumn (see BAN 10/19/2005).

The new BSE test was developed through ExonHit's diagnostics program, Bracco said. BioMérieux, the firm's main partner in that program, has expressed interest in the market for food safety tests and launched a FoodExpert ID test on the Affymetrix program two years ago (see BAN 10/22/2003).

ExonHit recently strengthened an agreement with BioMérieux to co-develop biomarkers for use in cancer diagnostics. However Tocque said that ExonHit had limited interest in pursuing other projects related to food safety.

"We don't want to get into that field," he said. "It's just one aspect of our blood diagnostic program, which as of today relies on the exclusive program we have with BioMérieux in the cancer field," he said. Tocque explained that ExonHit had become interested in BSE due to its interest in neurodegenerative diseases.

— Justin Petrone ([email protected])


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