Diagnostic Development Begun for Breast Cancer

The launch of a formal breast cancer diagnostic development program based on a series of biomarker discoveries has been announced by Ciphergen Biosystems, Inc. (Fremont, CA, USA). The discoveries were made using Ciphergen's surface enhanced laser desorption/ionization (SELDI) technology and Pattern Track biomarker discovery process.

The process began with an original study published in 2002 detailing the discovery of three serum biomarkers that can improve detection of breast cancer. Two of the three markers have been identified and validated by studies. The first study validated and identified the complement protein C3 as a biomarker for breast cancer. The sample cohort from three sites consisted of 46 age-matched healthy women, 32 with ductal carcinoma in situ, 37 with various benign breast disease, and 61 with locally invasive breast cancer. Another study showed C3 as an up-regulated biomarker and also confirmed the down-regulation of breast cancer marker one (BC1) from a former study. Further identification of BC1 is ongoing.

Ciphergen plans to expand its breast cancer development program based on these promising results. Expanded studies are planned with the University College of London (UCL, UK) and UCL BioMedica plc (also in London), which will involve analysis of samples collected from 200,000 women for breast and ovarian cancer and is expected to complement Ciphergen's current collaboration with the Johns Hopkins School of Medicine (Baltimore, MD, USA).

"Only 63% of breast cancers are localized at the time of diagnosis,” said Gail S. Page, president and CEO of Ciphergen. "Ideally, most women would prefer a simple blood test that would measure molecular markers for the presence of an early lesion. At Ciphergen, we are planning multi-site studies to validate several candidate biomarkers that could form the basis of a multi-marker assay to detect ductal carcinoma in situ (DCIS), since the majority of women diagnosed at this stage can be cured.”




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