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Patent Allowances in EU, India, Australia Enable DiaGenic to Begin Selling Its Dx

DiaGenic this week said that it has received a notice of allowance from the European Patent Office for its gene expression-based Alzheimer’s disease diagnostic.
When granted, the patent will be valid in 19 European countries and cover the use of differentially expressed informative probes for diagnostic purposes, the Norwegian life-sciences company said.
DiaGenic previously received a European patent, EP0979308, covering only the use of informative probes isolated by non-sequence-based methods for diagnostic purposes.
“From our point of view it is a real milestone for several reasons,” CEO Erik Christensen said this week. He said that not only will the newly awarded IP protect the company from potential litigation, it will also make it a more attractive partner for future diagnostics collaborations.
The Europe allowance comes as the company seeks to protect its IP worldwide as it transitions its focus from research and development to commercialization. For instance, DiaGenic has recently been notified that the Indian and Australian patent authorities have accepted the claims comprising the use of gene sequences in the detection of, among other indications, breast cancer and Alzheimer’s disease.
In 2004, the US Patent Office awarded DiaGenic a patent to use gene-expression signatures to diagnose Alzheimer’s disease, and the European patent similarly covers the use of expression signatures. However, Christensen said that the European patent includes the use of “more modern, non-sequencing base methods,” and said the allowance will be a “cornerstone in DiaGenic’s communication towards [the] market in Europe.”
DiaGenic has developed array and RT-PCR-based assays for Alzheimer’s disease and breast cancer. The company partnered with UK-based Opaldia last December to offer a research-only version of its early stage breast-cancer test to private clinics. Opaldia has also secured the rights to sell DiaGenic’s early-stage Alzheimer’s test in the UK when it becomes available (see BAN 12/18/2007).
Meantime, the company is working with an undisclosed Indian lab to eventually bring the breast cancer test to the Indian market by the end of this year. Christensen said that DiaGenic’s global strategy is to enter into partnerships, such as the one with Opaldia, to make its tests available rather that entering the market on its own.
The company believes that having its patents protected in as many countries as possible will help it secure more partnerships and facilitate the launch of its diagnostics as they become available.

“Due to a strike, our cartridges were stuck for weeks in customs in India in 40 degree [Celsius] temperatures and they were not destroyed.”

“We are creating good protection within this diagnostic field,” he said. “We have a goal of worldwide protection for our technology and patent applications are in process in all major markets,” said Christensen. “There are different speeds for different countries. So we will still have ongoing applications in Europe and US about other diseases in this area.”
Europe, India, US
As evidenced by the deal with Opaldia, DiaGenic plans to debut its first diagnostics in Europe, taking advantage of the relatively simple process for obtaining a CE Mark. “In Europe it is a speedier approach” than in the US, he said. “We plan to have EU approval of both our breast cancer and Alzheimer’s tests by the end of this year, and we are looking forward to having revenues in the second half of this year from our partnership in the UK that will increase into 2009.”
The company will also try to enter the Indian market with help from its undisclosed partner. Christensen said that patent coverage in India sends an “important signal” that DiaGenic is protected.
“We are looking into strategic partnerships in India to have long-lasting cooperation for targeting that market,” he said. “For the major players in that marketplace IP is important.”
DiaGenic originally developed its tests to run on Applied Biosystems’ RT-PCR TaqMan 7900 HT platform as well as on Applied Microarrays’ CodeLink bioarray platform. Christensen said that, for now, both Opaldia as well as DiaGenic’s India partner will be using the 7900 to run the breast cancer assays.
“One of the reasons for success in India is the use of these cartridges,” Christensen said of the 7900 platform. “Because it is a more closed system with microflidics inside, it can sustain the environment and challenges of India,” he said. “Due to a strike, our cartridges were stuck for weeks in customs in India in 40° [Celsius, 104° Fahrenheit] temperatures, and they were not destroyed.”
Christensen said that DiaGenic has had an extensive relationship with Applied Biosystems and that the firm might count on ABI as a partner when it eventually seeks to bring its tests to the US market. He said that ABI’s planned spinout from Applera this summer could kickstart talks about deeper collaboration.
“Then it will be ABI’s liberty to make decisions within their field that won’t be restricted by Applera’s diagnostic preference,” he said. “From my point of view it is an interesting development within ABI, and we have had a long relationship with them.”
However, he hinted that other platform providers, including array vendors, have been interested in talking with DiaGenic about partnering on bringing its tests to the US market. “We are having ongoing dialog with the management of several US platform providers and we are looking at next-gen [sequencing] platforms,” he said.
Christensen added that the company is “not only focusing on RT-PCR,” but that it also has the “liberty to choose from several different platforms,” including CodeLink. He said that once the tests had shown superior technical performance on the platforms, Diagenic would also consider pricing and regulatory issues before further developing the tests.  
“These companies are now looking for opportunities within the diagnostics market as well as in the research market,” Christensen said of DiaGenic’s potential US suitors, whom he declined to name. “We are providing the applications needed for these platform providers to enter the US diagnostics market and large US trials have to be performed.”

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