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Norway s DiaGenic is Latest to Throw Lot Into Alzheimer s Disease Molecular Diagnostics

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Joining the race to produce a molecular diagnostic related to Alzheimer's disease, DiaGenic has teamed up with Applied Biosystems to confirm a set of blood-based biomarkers it plans to use in a test for early detection of the disease.

The Norwegian company has added itself to the list of contenders for a fairly large market. The molecular diagnostics companies already angling for an Alzheimer's diagnostic of their own include Ciphergen, Genaissance, and Celera Diagnostics, but it's difficult to tell who is closest to the finish line.

About 4 million Americans have been diagnosed with Alzheimer's disease, according to the US National Institute of Mental Health. A definitive Alzheimer's disease diagnosis depends upon direct examination of the brain, but there are a few immunohistochemistry tests that check for variations of beta-amyloid proteins and tau proteins in cerebrospinal fluid.

ABI will be the platform provider for the Alzheimer's test, should the testing of a DiaGenic prototype go well, Richard Hayhurst, a spokesperson for the company, told Pharmacogenomics Repoter sister publication BioArray News this week.

Martinsried, Germany-based IMGM Laboratories will validate the company's biomarkers with a test of about 400 samples using ABI's microarray platform and TaqMan assays, said Marion Hirt, the head of IMGM's Gene Expression Center. IMGM expects to finish the study by the end of this year.

DiaGenic already has a preliminary list of IVD-ready biomarkers, according to company representatives. "We have identified a set of predictive genes for Alzheimer's disease, but it is based on a study with a very limited sample size," said Praveen Sharma, the firm's technology and product development director. "Together with IMGM we will have a much larger set of samples including several controls."

DiaGenic said that it will begin developing a prototype test after it receives the results of the study from IMGM. The company then expects to enter into discussions with a larger commercial partner, such as an "IVD company or service lab," that can distribute the test, Dag Christensen, the frim's marketing director, told BioArray News.

DiaGenic will have "full coverage of any IP linked to this discovery," Christensen told BioArray News. ABI was not able to comment on the partnership before press time.

Ciphergen has an amyloid-beta assay that it provides to clients for research purposes only, said Carol Berry, head of corporate marketing for Ciphergen. "We'll probably launch a few of our assays next year," through Ciphergen's alliance with Quest Diagnostics, she said.

The utility of early Alzheimer's disease detection is that it can direct more aggressive treatment — such as with the drug Aricept, a product of Eisai and Pfizer, Berry suggested.

Ciphergen announced last year that it and its collaborators had discovered 39 biomarkers in cerebro-spinal fluid associated with a variety of Alzheimer's disease parameters, four of which were used to identify 29 of 30 Alzheimer's patients and 33 of 35 normal patients, said Berry.

Ciphergen is now "in the midst of determining whether or not those biomarkers could be a diagnostic test at some point," Berry said. One key to producing a diagnostic is to ascertain whether the four biomarker proteins Ciphergen has chosen from among its panel of 39 are equally useful in serum, versus cerebro-spinal fluid, she said. "We're still in the assay development phase of this thing, and in some of the future meetings we're going to be presenting some of that data."

In the meantime, pharmaceutical companies are interested in using Ciphergen's biomarkers in drug development, Berry said. The company will be issuing announcements this quarter regarding pharma's interest, she added.

Also in the search for an Alzheimer's disease diagnostic, Celera Diagnostics has been involved in a project with Merck since last year to identify novel targets for drug discovery and diagnostic markers. Merck receives rights for therapeutic applications, while Celera Diagnostics will retain the rights to diagnostic applications, according to a Celera statement.

"We've been working with Merck very closely on the [partnership]," David Speechly, a Celera spokesperson, told Pharmacogenomics Reporter this week. "We just completed the research phase of that just in the last few months, and we're looking at various ways of moving that forward," he said.

Celera has extensive R&D invested into the area, Speechly said. "We've done discovery, we've done replication, we're working through the cornerstone of the utility studies, and that's pretty much what the process is" in the development of the company's late-onset Alzheimer's diagnostic. He declined to specify when the company might produce a diagnostic product in the disease area.

"A lot of people are doing a lot of work in this area," said Speechly. "It's the size of the sample" that matters when it comes to validating tests and biomarkers, and the company is using samples "significantly larger than a few hundred" for Alzheimer's, he said.

Genaissance, meanwhile, is working with an unnamed partner to try to uncover markers for predisposition to Alzheimer's disease, the strongest of which are linked to a particular age of disease onset, said Richard Judson, the company's CSO.

The company has "struggled" with the idea of developing a diagnostic, partly due to evidence in the scientific literature suggesting that five particular genes are needed to predict age of disease onset, said Judson. Genaissance has submitted a patent application for one of these genes, Trk1. Athena Diagnostics has a test for another, ApoE, but no one knows what the third, fourth, and fifth genes are, he said. The American Psychiatric Association has gone on record asking that physicians refrain from recommending the Athena test because an incomplete answer can sometimes do more harm than good, Judson added.

— Chris Womack ([email protected])
and Justin Petrone ([email protected].com)

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