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Drug-Diagnostics Co-Development in Oncology
The idea of combining drugs and diagnostics in oncology is not new. When the selective estrogen-receptor modulator tamoxifen was developed in the 1970s for the treatment of breast cancer, data
on estrogen-receptor status were correlated with the treatment outcome. Based on a phase II study performed in patients with advanced breast cancer, published in 1976, the investigators concluded:“a
high degree of correlation between response and positive estrogen-receptor assay suggests the value of the diagnostic test as a means to select patients for tamoxifen treatment” (1). Despite the fact that this conclusion was drawn nearly 40 years ago, the
adaptation of the drug-diagnostic co-development model has been relatively slowand it is only within the last decade that it has gained widespread acceptance.
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