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European Consortium Gets $427,000 to Develop Technology, Protocols for Handling Blood Samples

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This story originally ran on Aug. 26.

A consortium headed by Swedish sample-preparation firm Denator has received €300,000 ($427,000) from the EU Eurostars Programme to improve the handling of human blood plasma samples with the aim of advancing discovery of blood-based protein biomarkers.

With the funding, announced this week, the consortium expects to develop an instrument to use in the handling of blood samples, as well as protocols for handling the fluid.

The Eurostars funding is for 20 months, though work is expected to continue beyond that, Charlotte Emlind Vahul, head of business development for Denator, based in Gothenburg, told ProteoMonitor this week.

Eurostars is a joint initiative between Eureka — an intergovernmental initiative to spur on technology R&D projects in Europe — and the EU Seventh Framework Programme for Research and Technological Development, and is aimed at encouraging small companies to develop new products. In addition to the €300,000 from the program, the four members of the consortium will also be contributing money to the project, bringing the total budget to €495,000.

The consortium members are Sigolos, a technology firm based in Uppsala, Sweden; the Biomolecular Mass Spectrometry Unit at Leiden University Medical Center in the Netherlands; and the BioScope group at Universidade Nova de Lisboa in Portugal.

A large drug firm that Emlind Vahul asked not be identified will also provide support to the project.

Last year, Denator launched the Stabilizor T1 for the instant stabilization of tissue samples. By stopping degradation in tissues, the instrument allows researchers to study biological samples and their proteins and peptides closer to an in vivo state.

While Emlind Vahul said that market reception to the instrument has been "very good," and Denator is "very pleased" with it, the company knew that the greater market opportunity lay in blood, probably the most commonly used biological fluid for testing. Specifically, the need is for technology that can separate plasma efficiently from whole blood.

"The way that blood samples are handled today is not good enough to ensure that degradation doesn't take place," she said. "Like everyone else, we're interested in seeing what actually the in vivo state of the sample is. We want to know what's in the body, not what is the result of degradation that goes on after we've taken the sample from the body."

Though Denator had been mulling over the idea of creating an instrument similar to the Stabilizor T1 for use with blood samples, even as it was developing the Stabilizor T1, it knew it needed outside partners to do so. Late last year, the company began work on such a system, but as a small shop founded in 2004, "we don't hold all the competencies that we would need for the project in house," Emlind Vahul said. "The development so far has been in house, but we see it [being] beneficial to bring in partners with new perspective [and] competencies. And in terms of getting the word out there and showing what we're doing, working with different universities and big pharma is, of course, very beneficial."

Denator approached the other members of the consortium and applied for the Eurostars funding last November. In June, they were told they would be getting the funding. The first installment of the funding will be dispersed after the four partners sign an official agreement and deliver it to Eurostars.

According to Emlind Vahul, the consortium applied to the Eurostars program because as a small company, Denator felt its chances for one of the larger EU grants, such as a Framework 7 grant, were slim. The Eurostar program, however, is directed at businesses such as Denator. In addition, its grants are specifically for developing products, rather than general research, exactly the goal of Denator and its partners.

As part of the project, Denator and Sigolis will continue improving Denator's plasma-sampling platform by developing prototypes and parameters and tweaking it. Leiden University and the Universidade Nova de Lisboa will conduct biological verification and validation work, as well as identify biomarkers of disease and degradation.

At this stage, no specific disease groups are being targeted, Emlind Varhul said. The two universities will also be addressing the dynamic range of blood and attempting to find low-abundance biomarkers via a number of different strategies, though she declined to elaborate.

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The top-10 drug firm participating in the effort will be providing input to ensure the instrument being developed will meet the needs of large pharma in their drug-development work.

The system would be targeted to the clinical setting, including hospitals, clinics, and labs, as well as at pharma and biotech.

While the Eurostar funding is for 20 months, Emlind Varhul said that, realistically, it will take between three and four years before a system could be commercially available, the same amount of time it took to bring the Stabilizor T1 from the development stage to market.

Denator is currently securing intellectual property rights for the system and Emlind Vahul was reluctant to describe in great detail the instrument but said that it "aims to better sample preparation and sample handling, meaning it would be easier, quicker, and better than the existing solutions out there today," at preventing degradation and improving separation of plasma from whole blood.

The company is doing pilot studies on the instrument, "which are looking really good," she said. The system has not reached the beta stage yet, but "we have some proof of concept that it works and it will work," she said. "Is it working as well as we want? Not yet, but we have a fair understanding of how we will get there."

In addition, the consortium is developing protocols for the handling of blood samples, a problem that all researchers are aware of but which the proteomics field, in actuality, has done little to solve.

"The way blood samples are handled today [is] a very long [but] not standardized process" Emlind Vahul said. As a result, samples can become corrupted and potential information can be lost, and tests based on the samples may come back with erroneous or inconclusive findings. In protein biomarker research, poor sample-handling methods have been identified as a significant reason for the poverty of biomarkers that have reached clinical stage.

The sampling process "depends on where you are and how rapidly you can get access to the blood, and that takes [anywhere] from 10 minutes to hours," Emlind Vahul said. "And during that period of time, a lot of things have occurred in the sample. It's very difficult to be certain what the in vivo state of that sample [is].

"What we want to have is a standardized way of handling it so that you can compare, regardless of [whether] you're a clinic in New York or a research group in Uppsala. The ultimate aim would be that the same sample handling of the blood plasma would be in place, so that it would be easier to compare the quality and the results of the plasma," she added.

Due to IP concerns, she declined to describe in detail the consortium's protocol development work but said "what we see is it takes too long, there's too much risk of degradation … of distortions and variations between samples, so for us, the main focus" is on improving the handling of the blood.

In a statement, Yuri van der Burgt, assistant professor at Leiden University Medical Center, said the work of the consortium could improve biomarker discovery. "Improved and standardized sample handling is a key issue for the discovery of novel peptide- and protein-based biomarkers. This project holds the potential of immensely facilitating that process."

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