DiaGenic announces preliminary results from Indian breast cancer study

Pesenting preliminary results of its multi-centre breast cancer study using its early breast cancer gene expression blood test at The Federation of Obstetrics and Gynecology Societies of India (FOGSI) annual meeting in New Delhi, Norwegian biotechnology company DiaGenic ASA, said the results showed "good diagnostic performance."

DiaGenic said, the results from the first 113 patients show that the gene expression signature, previously identified in Scandinavian and US cohorts, shows good diagnostic performance in an Indian population. Preliminary data shows similar levels of accuracy obtained with the European / US cohorts as for the Indian cohort. DiaGenic now aims to complete the study of 720 subjects in the next few months and is in dialogue with local partners to market the test in India.

The DiaGenic breast cancer blood test offers a unique range of advantages over existing methods. Firstly, the use of venous blood as the test-sample is patient-friendly. The test also detects breast cancer in pre-menopausal women with good accuracy whereas mammography has major problems due to high breast density, which obscures the mammographic image. This is especially important in India, where breast cancer is seen at a significantly lower age than in Western countries. Finally, the disease can be discovered at a very early stage, thus paving the way for effective intervention.

One of the key investigators in the trial, Dr Yathish Kumar, Panacea Hospitals Pvt. Ltd, Bangalore, welcomed the initial results, explaining that there is a major need for an early blood test in India: "Currently, survival rates for breast cancer are low in India and there is not an effective screening programme. Furthermore, Indian women tend to have denser breast tissue and to suffer from the disease earlier than in the West. Using blood as the sample material and being able to screen earlier is thus an extremely attractive proposition and would enable us to start tackling the problem effectively."

DiaGenic CEO Erik Christensen commented: " This study demonstrates that there is no ethnic variability in the gene expression signature that impacts the diagnostic performance. Working with an excellent CRO and service laboratory, we have been able to both recruit patients from right across the Indian subcontinent and to successfully transfer the testing procedure to an Indian laboratory. These initial results give us the confidence to prepare for making the test commercially available through a local partner in India."

DiaGenic is currently a world leader in analysing gene expression signatures related to disease in easily available clinical samples such as peripheral blood. This unique method is based on the principle that even when a disease is localised at a specific part of the body, secondary responses, which are also characteristic of the disease, can be measured in other parts. Significant potential in numerous diseases such as breast cancer, Alzheimer's and Parkinson's disease has been identified. The company has been granted patents in the US and Europe.