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European BioPharmaceutical Review
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| Voula Kodoyianni at GWC Technologies, Inc and Richard Rouse at HTS Resources LLC look at personalised therapeutics and discover how unique genetic fingerprints can lead to more effective disease treatments
Researchers have worked hard to find genetic causes for various diseases, and their discoveries are reshaping the way medicine is practiced today. During the past decade in particular, science has experienced an exponential growth in understanding about gene-disease relationships. Now, genomic technologies are being integrated into clinical applications, such as a clinically validated laboratory test developed by Genomic Health.
The OncoType DXTM is designed to predict the likelihood of breast cancer recurrence in women with newly diagnosed, early-stage invasive breast cancer. It also forecasts each patient’s unique response to chemotherapy. Predictable patterns of genomic expression are increasingly recognised by clinicians as important therapy decision-making tools. They complement pertinent diagnostic information from traditional clinical data sources, such as the IHC test for oestrogen receptors (ER) and progesterone receptors (PR), as well as Her2/neu and EGFR and their gene amplifications/mutations. Diagnostic imaging systems such as CT, MRI and PET scans, along with molecular-level patient and disease monitoring methods, are employed to initiate suitable therapy and monitor tumour responses to specific treatments.
While OncoType DXTM profiles 21 breast cancer-related gene expressions, its rival assay, MammaPrint® by Adgendia, monitors 70 genes linked to breast cancer and provides information about a patient’s risk of disease recurrence. MammaPrint® predicted the 10-year survival of patients at a significant level of accuracy (96.7 per cent), over three times greater than existing methods (1). Recent FDA approval is a positive indicator regarding the trend of the application of molecular science and technologies for therapy management. There seems to be a bright future involved in taking genetic information and using it to enhance patient care. |
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Voula Kodoyianni is Chief Scientific Officer for GWC Technologies, Inc, which develops and markets labelfree array analysis systems for the life scientist. Voula holds a Master’s degree in Organic Chemistry from Duke University and a PhD in Biochemistry from the University of Wisconsin-Madison. Prior to her current position, Voula was a Howard Hughes Medical Institute Fellow in molecular biology and Team Leader in a human genome sequencing project at the University of Wisconsin, Madison. Voula is co-inventor of the SpotReadyTM chip, a patented product offered by GWC Technologies, Inc.
Richard Rouse is a Technical Applications Specialist who runs HTS Resources, LLC, a company based in San Diego California, US, that focuses on providing microfluidic instrumentation, microfabrication and research services. Much of the work Richard does is related to protein microarray technologies. He is a USPTO registered patent agent who drafts patents from time to time. |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
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Improving the patient recruitment process is imperative to avoid wasted
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