By Arun AK, Research Associate, Clinical Diagnostics - Healthcare

Clinical diagnosis forms the basis for any better therapeutic outcomes. Though effective drugs hold the key, timely and accurate diagnosis forms the corner stone in the treatment of any pathological condition. This holds true for life threatening diseases like cancer which is one of the most deadly disease of this century.

Although various types of cancer continue to burden the human race, breast cancer continues to be one of the most threatening diseases for women worldwide. It was estimated that the incidence of this disease is on a rise and around 300,000-400,000 deaths occur each year. But medical advancements and better treatment options had a check on the mortality rate of this disease which has improved the quality of life amongst the patients.

Present day diagnosis

Today physicians have handful of options for diagnosing breast cancer. But very few have found a sound application in diagnosing the disease. Imaging techniques like digital mammography, biopsy techniques and normal breast examinations are most commonly performed tests to detect any lumps or the severity of the disease. But simple and accurate clinical test for detecting breast cancer is the need for the day as early detection improves the survival rate of the patients.

In-vitro diagnosis and breast cancer

There are several tests available in the market to diagnose breast cancer. The first blood test to be approved by FDA in this front is the one developed by Biomira Diagnostics Inc. in 1996 for detecting the recurrence of breast cancer. The test is a simple radioimmunoassay which measures CA 27.29, a tumor marker. Though tests like HER-2 / neu breast cancer testing, measurement of cancer antigen (CA) 15-3 levels are available currently, these tests are mainly helpful for better patient management. So the quest for clinical test that help in early diagnosis of breast cancer is still continuing. Research and developments in this horizon is convincing and breast cancer diagnostics market is likely to explode once these new products hit the market.

Novel technologies hold the promise

Two research collaborations in breast cancer diagnosis holds huge promise for the future. Both these research agreements were initiated in 2003 by two IVD companies based on novel technologies.

ExonHit’s alternative splicing technology was identified as one of the future potential in cancer diagnostics by bioMérieux, and entered in to an agreement to mutually benefit from individuals strength. ExonHit has applied its gene profiling technology DATAS (Differential Analysis of Transcripts with Alternative Splicing) and found 54-gene signatures for breast cancer which can potentially be helpful in distinguishing healthy females from those with early stage breast cancer.

On the other hand, Roche Diagnostics has entered in to an agreement with Epigenomics, the pioneers in DNA methylation technologies, to develop diagnostics products for use in early detection of cancer. DNA methylation is a natural phenomenon which prevents the expression of all genes in cell to be expressed at the same time. Disease identification based on this methylation process involves identifying differentially methylated cytosines corresponding to particular disease which aids in early detection of the disease. The promise of this technology has already attracted many researchers and currently more research is carried on this front by both new innovative and IVD companies.

Other promises in this field include the research collaboration between Abbott and Europroteome AG which involves utilising proteomic and bioinformatic technologies to identify novel markers for breast cancer diagnosis and potential screening.

Further a recent research study (August 2006) in colloboration between University College London in the UK and the University of Pennsylvania in the US has found that combinations of protein markers can be helpful in screening several cancers in one blood test.

Conclusion

The in vitro cancer diagnostics market was totaled to approximately $420 million in 2005 and the current technological advancements is likely to open new vistas in the next 4 – 5 years which will bolster the growth of this market. Further the rising incidence rates of this disease along with growing awareness amongst women is forcing the scientists to advance the research process which will prove beneficial both for the people and the companies.

This article originates from Frost and Sullivan

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