DiaGenic, a Norwegian in vitro diagnostics company developing an array-based test for early breast cancer detection, is looking for a chip vendor to help it develop and eventually launch the product, the company said last week.
The publicly held company said it initially developed the gene-expression profiles for the test with home-brewed macroarrays, but through research learned that the test works on Agilent’s microarray platform, and that it may work with other commercial microarrays as well.
“The study confirms that the diagnostic information relating to breast cancer can be mined from the Agilent platform,” Dag Christensen, DiaGenic’s vice president of marketing, wrote in an e-mail to BioArray News. “If it works on Agilent it will also work on other platforms of similar quality.”
DiaGenic is now testing the accuracy of the diagnostic using a variety of commercial platforms at the Norwegian Radium Hospital. The firm said that the fact the test works with commercial chips broadens the field of possible collaborators for the development of its IVD.
“This opens up [the possibility] for the development of a product for early diagnosis of breast cancer, which could be very important for treatment and survival with respect to this disease,” said Anne-Lise Børresen-Dale, who runs the lab at the hospital where the tests are being conducted.
DiaGenic said that it can develop the test on schedule in 2006 with a budget of NOK 10 million ($1.6 million), and that it was looking to partner with a platform provider within the first half of 2005. Since it was founded in 1998, the Oslo-based firm has raised NOK 60 million in private funding and public grants.
DiaGenic did not set a tentative date for a product launch.
Christina Maehr, a spokesperson for Agilent, said she could not comment on whether Agilent was involved in discussions with DiaGenic, but said the firm is interested in partnering for these kinds of diagnostic tests. “We are already in discussion with some parties about possible diagnostic opportunities and we are absolutely interested in having more of those discussions,” Maehr said.
Maehr said she was aware of several companies that were developing IVDs on the Agilent platform. Agilent already is the platform-supplier for MammaPrint, an IVD for the recurrence of breast cancer developed by Agendia (see BAN 12/15/2004).
“We believe that there are a number of researchers that are developing or identifying signatures for potential diagnostic use on our platform,” she said.
Another possible partner for DiaGenic could be Applied Biosystems. According to Tracy Ferea, the head of microarrays at ABI, her firm has been working with the Norwegian Radium Hospital, and the duo have been able to identify 582 genes in different subclasses of breast cancer. Ferea told BioArray News at the World Microarray Congress in Vancouver, BC, last week that ABI was aware of DiaGenic’s efforts to find a partner for a prospective IVD for early breast cancer.
According to Dag Christensen, DiaGenic developed the gene-expression profiles for the test by using home-made macroarrays to compare blood from women with breast cancer against women without the disease. Christensen said that his company had identified a certain number of genes that could be used in a diagnostic. DiaGenic has not reported how many or which genes may be targeted in its diagnostic test.
Central to DiaGenic’s approach is the theory that diagnostics can be run on simple blood samples taken from the patient, as opposed to other tests that use biopsy samples.
The company is currently using the same methodologies to develop a diagnostic for Alzheimer’s disease. Christensen would not speculate as to when such a test would become available, but said “due to medical need” DiaGenic may “experience a higher speed on [its Alzheimer’s] project and therefore a shorter time to market,” than its breast cancer IVD.
“The samples are being collected [now] and the analysis is planned to start just after summer,” he said.
The company said that because its method using blood samples has been confirmed to work on a commercial platform, it could shave time off future development of a similar diagnostic, like the one being prepared for Alzheimer’s.