Oncotype DX Development
Oncotype DX® was developed in multiple clinical trials using breast cancer tumor samples that had been stored, or archived, following surgery.
Studying breast cancer genes
First, studies were performed to identify a large number of genes associated with breast cancer. Genomic Health® performed its own studies in this area and also relied on the extensive databases developed as part of the Human Genome Project, as well as other sources in scientific literature. Many of these studies were conducted using research tools called microarrays, which are capable of performing whole-genome analyses of tissue samples and determining whether specific genes are expressed.
Clinical trials
Once highly relevant groups of breast cancer genes were selected, Genomic Health performed clinical trials with leading oncology centers to explore the correlation of gene expression (using the identified genes) with likelihood of breast cancer recurrence.
Applying their proprietary technology, Genomic Health conducted trials looking at the gene expression profile of each individual tumor. They then matched each genomic profile with the patient's clinical outcome to see whether or not breast cancer recurred, thus determining which specific genes correlated best with recurrence.
A formula for determining recurrence
The team at Genomic Health selected a specific set of genes from these early studies. After analyzing hundreds of samples, the team developed a mathematical calculation that could help determine the likelihood of recurrence with precision. This formula results in one number, the Recurrence Score®, which is easy to interpret by the healthcare provider. To verify its accuracy, this calculation was validated in additional clinical studies involving over 650 breast cancer patients. The gene expression analysis technology and the formula are the two key components of Oncotype DX.
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