DiaGenic ASA, a Norwegian company and the winner of Frost & Sullivan 2007 Entrepreneurial Company of the Year Award in the European molecular diagnostics market, is planning to introduce early next year a blood test to detect breast cancer in its earliest stages. Opaldia, United Kingdom’s private breast cancer care provider, will be distributing the genetic diagnostic blood test in the country, according to a press release.
At the heart of the test is the technology called Gene Expression Signatures, which is essentially expression patterns of noncancerous genes detected from samples of peripheral blood, that the company believes could be characteristic enough to be used to help diagnose early breast cancer. DiaGenic reports that its blood test “has been validated in international trials, most recently in India, suggesting there is no ethnic variability in the gene expression signature.”
DiaGenic’s unique and patent-protected concept for the diagnosis of disease is based on the finding that even when a disease is localized at specific body site, secondary responses that are also specific for the disease can be measured in clinical samples obtained from the peripheral parts. One such response includes characteristic changes in the expression pattern of selected genes in peripheral blood samples. DiaGenic’s concept involves identifying these genes and using them to develop a disease-specific gene expression signature to form the basis of a diagnostic test.
Being able to base a diagnosis on the analysis of gene expression signatures in sample material taken at a distance from the site of the disease, such as peripheral blood, has clear advantages for both patients and clinicians. Most competitors that are developing products based on gene expression use sample material taken from the site of the disease, namely tissue samples obtained by biopsy. This traditional approach has severe limitations. For example, there has to be a suspicion of the disease, which is not required with DiaGenic’s concept. DiaGenic also has a significant advantage in cases where it is impossible or extremely difficult to take samples from the site of the disease itself. This is particularly important with neuro-degenerative diseases, such as Alzheimer’s disease, and various forms of cancer – diseases where today we lack good diagnostic tools. Against this background DiaGenic has chosen to focus on the two diseases, breast cancer and Alzheimer’s disease.