Blood Tests for Early Detection of Breast Cancer

The data were presented at the annual meeting of the American Association for Cancer Research in April 2006 in Washington (DC, USA).

The data were announced by French drug and diagnostic company ExonHit Therapeutics (Paris, France) and bioMirieux (Marcy l'Etoile, France), a major provider of in vitro diagnostics. A blood test would enable clinicians to make a better therapeutic decision more quickly, thereby improving the chances of successfully treating patients.

The research enabling such new diagnostics is based on ExonHit's expertise in identifying specific genetic signatures from alternative RNA splicing associated with diseases and will capitalize on bioMirieux's know-how in developing and commercializing diagnostic tests.

The scientific data show that a panel of genetic signatures identified by ExonHit can clearly distinguish healthy women from those with early-stage breast cancer. A total of 54 genes were able to correctly classify, with accuracy of 86.7%, a group of 92 women, 55 with stage I/II breast cancer and 37 healthy women. A prospective multi-center clinical study of 1,000 women has been initiated to validate the specificity and selectivity of the markers identified.

"These results provide a clear proof of concept that by using a well-characterized set of molecular markers in blood it can be possible to develop a valuable diagnostic test for breast cancer,” observed Bruno Tocqui, president of the management board of ExonHit Therapeutics. "This is an extremely positive development, which I view as a first success in our collaboration with bioMirieux. We are very pleased to work with bioMirieux to manage a multi-center clinical study, the next stage in the development of what we believe could be a major advance in the diagnosis of breast cancer.”

ExonHit applied its gene profiling DATAS (Differential Analysis of Transcripts with Alternative Splicing) to the blood samples of healthy women and stage I/II breast cancer patients, which led to the identification and isolation of a set of genes. The most significant diagnostic markers have been identified using ExonHit's SpliceArray technology applied to the microarray platform of Affymetrix (Santa Clara, CA, USA). As a result, the 54-gene signature was capable of correctly classifying 86.5% of the controls (32/37) and 92.7% of the breast cancers (51/55).



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