DiaGenic announced this week that it has concluded its discovery work on an early-stage, peripheral blood-based test for Alzheimer's disease and that it has developed a gene-expression signature that can identify the disease in an individual with 87 percent accuracy.
DiaGenic CEO Anders Lönneborg said in a statement that developing the signature represents "a major step" towards DiaGenic's goal "to develop a simple blood-based test that will enable physicians to discriminate between non-AD and AD patients at an early stage."
"We are currently validating the results from the microarray platform on a RT- PCR platform, TaqMan, and have already found that the gene-expression signature can be transferred to commercially viable diagnostic platforms. Thus, we expect to be able to have the first product prototype ready for clinical trials by the end of this year," Lönneborg said.
Håkon Sæterøy, head of investor relations at DiaGenic, told BioArray News this week that the company has not decided yet whether it will sell its test for use on a microarray platform or with RT-PCR. Instead, Sæterøy said the company expects that the test could become available on multiple platforms.
"I believe that these types of studies will increase as soon as we can demonstrate that there is information stored in the blood that you can access easily and that reflects what is occurring elsewhere in the body. If we can prove that is true, then the number of projects will increase."
"It is too early to decide which platform will be the first one for commercial use. However, we expect that a number of platforms can be used, which is interesting since potential commercial partners are expected to have different preferences regarding platforms for commercial use," he said.
What separates DiaGenic from some other molecular diagnostic companies is that it is pursuing diagnostics that are based on peripheral blood samples rather than, for example, tumor biopsy material. The Norwegian molecular diagnostic firm last August announced its intent to develop the gene-expression signature with partner IMGM Laboratories. Together the companies used Applied Biosystems' Expression Analysis System and standard human arrays to develop the signature, according to the statement (see BAN 8/17/2005).
DiaGenic's announcement comes at the same time that IMGM is embarking on a second blood-base study using the ABI platform. The firm, an authorized ABI service provider, last week said it will use the ABI platform and peripheral blood samples to help an Austrian company test a dietary supplement it is developing.
According to IMGM CEO Mirko Vanetti, the project with the Austrian company, called SUK Vienna, is in its initial stages and that the partners are working together to establish efficacy for the supplement, called PanSan, in order to attract investments for further studies.
"We want to attract investors who will help us make the new study and we want to collect first evidence for effects," Vanetti told BioArray News last week. The firm currently only has animal data.
While IMGM is using ABI's platform, Vanetti said ABI is not involved in the project. Additionally, SUK will have all rights to the information that comes out of the study.
IMGM will generate the RNA data while another testing partner, TopLab, will generate protein data using electrophoresis, according to Vanetti. He said that IMGM expects more blood-based projects in the future.
"What's special about this is the ability to analyze genes from blood," Vanetti said. "Usually you would expect gene expression to occur somewhere in the body, in a specific tissue. But we have no chance to get into these cells and look at them, apart from animal studies, and that's why researchers are now considering blood as an alternative source," he said.
"I believe that these types of studies will increase as soon as we can demonstrate that there is information stored in the blood that you can access easily and that reflects what is occurring elsewhere in the body. If we can prove that is true, then the number of projects will increase," Vanetti said.
Vanetti added that the discovery project with SUK is likely to be concluded by the end of this year. SUK Vienna could not be reached for comment.
— Justin Petrone ([email protected])