DiaGenic, a Norwegian company developing array-based in vitro diagnostics, will use ABI's technology to validate a test it is developing for Alzheimer's disease, and will soon wrap up a large study that will help it refine its IVD prototype for possible commercialization, according to company officials.
Dag Christensen, the firm's marketing director, told BioArray News this week that DiaGenic will use Applied Biosystems' 1700 Expression Array System and Human Genome Survey Microarray to finalize its list of biomarkers for early detection of Alzheimer's disease. He added that DiaGenic will use ABI's RT-PCR-based TaqMan Assays to validate the results of the study, which will involve 400 samples and be carried out by DiaGenic partner IMGM Laboratories.
Christensen said the company partnered with ABI for the development of the test because "in our view ABI is able to offer a complete solution from the [initial] discovery with the whole-genome arrays and down to looking at singular genes validating with the TaqMan. Part of the agreement with ABI is that they will place the TaqMan instrument in our lab [and] we will lease that for a certain time," he said.
Christensen did not disclose financial details of the agreement, but said that DiaGenic will have "full coverage of any IP linked to this discovery."
"After we finalize this very large study and get the type of info that we are convinced is pioneering, [then] we will go in to discussions for commercial partners."
ABI declined to comment on the partnership with DiaGenic. A spokesperson from the firm told BioArray News that ABI plans to release an official announcement about the agreement in the next few weeks.
To help bring its early-stage Alzheimer's test to market, DiaGenic has turned to Martinsried, Germany-based IMGM Laboratories as its validation partner. Marion Hirt, the head of IMGM's Gene Expression Center, said last week that IMGM plans to use ABI and Agilent equipment to validate and discover more biomarkers for diagnosing Alzheimer's disease, working with samples from 400 individuals.
"We will be providing our laboratory equipment, including the ABI 1700 microarray platform and an Agilent BioAnalyzer [in our study]," Hirt wrote in an e-mail to BioArray News last week.
"The whole processing of approximately 400 samples will be carried out at our facility, starting from total RNA and resulting in the transmission of microarray data and quality check parameters to DiaGenic," she said. IMGM expects to finish the microarray experiments for DiaGenic by the end of this year.
Representatives from DiaGenic said that the company already has a preliminary list of IVD-ready biomarkers for detecting Alzheimer's disease, but the study is expected to help them validate and expand the list where needed.
"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. Together with IMGM we will have a much larger set of samples including several controls," explained Praveen Sharma, the firm's technology and product development director, in an interview this week.
Representatives from DiaGenic said they will present a poster on their work at the International Psychogeriatric Association meeting next month in Stockholm, Sweden.
"We will present the data that indicates that blood-based [gene] expression can be used to detect Alzheimer's disease," Sharma told BioArray News.
The company declined to add further detail to what may be presented at the IPA meeting in September.
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 that can distribute the test.
According to Richard Hayhurst, a spokesperson for the company, the partnership with ABI includes the study with IMGM, and if the test developed by DiaGenic goes forward, ABI will be the platform provider for the Alzheimer's test.
"We will evaluate the predictive genes we identify from a low-density array using these samples. What we anticipate is that after we validate these predictive genes then we will have a prototype and we will start some type of clinical trials or clinical studies," explained Sharma.
"We anticipate that after this study we will get a validated signature and we will have a kind of a prototype and at that stage we will go out and seek a partner for further product development. At this stage we do not want to go after real partner discussions, but after we finalize this very large study and get the type of info that we are convinced is pioneering, [then] we will go in to discussions for commercial partners," Christensen said.
He added that a "commercial partner" could be a larger "IVD company or service lab."
By moving ahead with that project, Christensen will be making good on a prediction he made earlier this year in an interview with BioArray News when he forsaw that "due to medical need" DiaGenic may "experience a higher speed on [its Alzheimer's] project and therefore a shorter time to market," than another IVD the firm is preparing for breast cancer.
Both tests use blood samples from patients to identify gene expression patterns that can be linked to early diagnosis in either disease.
Sharma told BioArray News this week that the company has been working with Agilent Technologies on its breast cancer IVD. "This project is continuing and we also intend to develop a commercial platform. Research with [the] Agilent [microarray] platform is going well, we are analyzing the data, and we hope to be able to deliver the prototype by 2006," he said.
Still, Anders Lönneborg, DiaGenic's managing director, pointed out that DiaGenic has "no direct agreement with Agilent like we have with ABI."
Stuart Matlow, a spokesperson for Agilent Technologies, confirmed that the companies are working together on the breast cancer IVD. "We indeed are working with DiaGenic in the development of diagnostics for breast cancer. It's still in the research stage, DiaGenic is developing these tests, but yes, they are using our platform," he said.
— Justin Petrone ([email protected])